J Clinic Periodontology - 2020 - Wang - Immediate Versus Delayed Temporization at Posterior Single Implant Sites A

Received: 24 April 2020 | Revised: 22 June 2020 | Accepted: 28 July 2020
DOI: 10.1111/jcpe.13354
ORIGINAL ARTICLE IMPL ANT DENTISTRY
Immediate versus delayed temporization at posterior single

implant sites: A randomized controlled trial
Joseph Wang1 | Gila Lerman1 | Nurit Bittner2 | Weijia Fan3 | Evanthia Lalla1 |
Panos N. Papapanou1
1
Division of Periodontics, Section of Oral,
Diagnostic and Rehabilitation Sciences, Abstract
College of Dental Medicine, New York, NY, Aims: We conducted a randomized controlled trial to assess the clinical outcomes of
USA
2 two loading protocols involving either immediate or delayed prosthetic temporiza-
Division of Prosthodontics, Section of Oral,
Diagnostic and Rehabilitation Sciences, tion of single implants placed at posterior, healed sites.
College of Dental Medicine, New York, NY,
Materials and Methods: Forty-nine patients in need of single implants at premolar or
USA
3
Department of Biostatistics, Mailman
molar sites were randomized to receive a temporary crown either immediately after
School of Public Health Columbia University, implant placement or 3 months later. Randomization was stratified by sex, implant
New York, NY, USA
location (premolar/molar) and arch (maxilla/mandible). Final implant screw-retained
Correspondence zirconia crowns with angulated screw channels were delivered at 5 months after sur-
Panos N. Papapanou, Section of Oral,
Diagnostic and Rehabilitation Sciences,
gery. Radiographic bone levels (primary outcome), peri-implant mucosal margin levels
Division of Periodontics, Columbia and peri-implant probing depths were recorded at baseline, 6 and 12 months after
University College of Dental Medicine, 630
West 168th Street, PH-7E-110, New York,
surgery.
NY 10032, USA. Results: Both treatment arms showed similar patterns of soft tissue and bone re-
Email: [email protected]
modelling from the implant platform over 12 months [mean bone level change 1.6 mm
Funding information (SD 1.0 mm) in the delayed, and 1.2 mm (SD 1.3 mm) in the immediate temporization
This study was partially funded through
a contract between the Office of Clinical
group], with the majority of changes occurring within the first 6 months.
Trials, Columbia University Irving Medical Conclusions: Immediate or delayed temporization of single implants placed at pos-
Center and Nobel Biocare Services AG,
Kloten, Switzerland (grant number 2014-
terior healed sites resulted in largely similar 1-year outcomes with respect to peri-
1287). implant bone levels and soft tissue changes.
KEYWORDS
dental prostheses, loading, partial edentulism, prospective, provisionalization
1 | I NTRO D U C TI O N Lazzara & Porter, 2006; Niznick, 1991; O'Sullivan, Sennerby, &
Meredith, 2000). New restorative options included screw-retained
The original osseointegration protocol, introduced in the late prostheses that eliminated the need for cement and facilitated
1970s, featured a two-stage approach (Brånemark et al., 1977). retrievability, but generally required precise implant placement
Successful clinical outcomes using parallel-walled implants paved for optimal restoration (Hebel & Gajjar, 1997; Wittneben, Joda,
the way for modifications in implant designs and prostheses. Weber, & Brägger, 2017). The recent introduction of an angulated
Developments included the introduction of tapered implants, in- screw channel compensates to a certain degree for unfavourable
ternal hex connections and platform switching (Callan et al., 2000; implant placement and allows fabrication of a screw-retained
ClinicalTrials.gov (ID NCT02387970).
© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
J Clin Periodontol. 2020;47:1281–1291. wileyonlinelibrary.com/journal/jcpe | 1281

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1282 WANG et al.
restoration without sacrificing aesthetics (Gjelvold, Sohrabi, &

Chrcanovic, 2016).
Clinical relevance
Loading times have also evolved, ranging from conventional to
Scientific rationale for the study: A variety of loading pro-
immediate loading (Aparicio, Rangert, & Sennerby, 2003; Degidi &
tocols exists for the restoration of dental implants. Data
Piattelli, 2003; Wang et al., 2006). Conventional loading calls for de-
comparing 1-year outcomes in immediate versus delayed
livery of a prosthesis after an unloaded healing period of at least
temporization of single implants at posterior sites are
3 months in the mandible and 5–6 months in the maxilla. Immediate
limited.
loading is defined as the placement of a restoration at the day of im-
Principal findings: At 12 months after implant placement,
plant surgery and can be either functional or non-functional (i.e. with
largely similar patterns in bone level and soft tissue re-
a restoration with or without occlusal contacts, respectively); this
modelling were observed between implants placed in
approach primarily facilitates aesthetic needs while guiding soft tis-
healed ridges that were temporized either immediately or
sue architecture during the healing period (Ghoul & Chidiac, 2012).
3 months later. Most of the observed changes occurred
However, both functional and non-functional immediate loading
within the first 6 months post-placement.
entail an increased risk for implant failure, as even minimal occlu-
Practical implications: Immediate temporization and de-
sal forces may cause micro-movement of the fixture during healing,
layed temporization of posterior implants appear to result
leading to soft tissue encapsulation and impaired osseointegration
in largely similar clinical outcomes one year after implant
(Strub, Jurdzik, & Tuna, 2012).
placement.
The above loading protocols are not fully substantiated by
solid research data, and clinical outcomes resulting from immedi-
ate versus delayed temporization approaches at posterior implant
sites have not been adequately documented (Del Fabbro, Testori, or poorly controlled diabetes (HbA1c > 8%); and (f) administration of
Francetti, Taschieri, & Weinstein, 2006; Esposito, Grusovin, bisphosphonates intravenously within a year prior to screening, or
Maghaireh, & Worthington, 2013; Sennerby & Gottlow, 2008). scheduled in the study period.
Therefore, the aim of this randomized controlled trial (RCT) was
to compare treatment outcomes at 6 and 12 months after implant
placement, attained through either an immediate or a delayed 2.2 | Primary outcome and sample size calculation
temporization protocol of single implants at posterior healed sites,
followed by delivery of a permanent zirconia crown with an angu- The primary outcome was peri-implant bone re-modelling, that
lated screw channel. is the change in the distance between implant platform and
bone crest, from baseline (time of implant placement) to 6 and
12 months post-surgery. Sample size calculation was based on
2 | M ATE R I A L S A N D M E TH O DS anticipated differences in the primary outcome between the two
treatment arms.
2.1 | Study design Based on similar published data, the expected bone re-modelling
was set at 1 mm in one arm and at 1.5 mm in the other arm resulting
The study was conducted at the Postdoctoral Periodontics and in an expected mean difference between the two arms amounting to
Prosthodontics Clinics of the College of Dental Medicine (CDM), 0.5 mm (Esposito et al., 2013). With a common standard deviation in
Columbia University. It was approved by the Institutional Review both arms of 0.6 mm, the two-tailed effect size for a Student's t test
Board of the Columbia University Irving Medical Center (IRB- (Cohen's d) amounted to 0.83 mm. With a significance level of 0.05
AAAO5901) and registered with ClinicalTrials.gov (NCT02387970). and power of 0.80, a sample size of 24 individuals per treatment arm
Inclusion criteria were as follows: (a) age ≥ 18 years; (b) single, was required to detect this difference between two arms using a
healed edentulous spaces at maxillary/mandibular, premolar/molar two-sided two sample t test.
regions, with extractions carried out >3 months prior to recruitment;
(c) teeth present both mesial and distal to the implant site; (d) ridges
free of clinically or radiographically evident pathology; (e) systemi- 2.3 | Enrolment and randomization
cally healthy individuals, or with well-controlled conditions; and (f)
availability for follow-up during a 1-year period after implant place- Enrolment was initiated in 2/2015 and was completed by 2/2018.
ment. Exclusion criteria were as follows: (a) pregnancy or pregnancy A total of 473 individuals were pre-screened by telephone, of
intention over the study period; (b) current smoking > 10 cigarettes/ whom 212 were screened in person by two clinicians (JW and GL).
day; (c) parafunctional habits/excessive occlusal forces, as evidenced To account for dropout, the study enrolled 52 patients meeting
by excessive occlusal wear and signs of bruxism; (d) current ortho- the inclusion criteria. Stratified randomization by sex, surgical site
dontic therapy; (e) uncontrolled hypertension (BP > 160/100 mmHg) (premolar/molar) and arch (maxilla/mandible) was conducted using
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WANG et al. 1283
(a)
(b)
FIGURE 1 (a) Enrolment flow diagram. (b) Study timeline
a pre-established scheme, and resulted in 25 patients assigned 2.4 | Surgical and restorative protocol
to the delayed temporization arm (DEL) and 27 to the immediate
temporization arm (IM). A patient flow chart and study outline are Two licensed clinicians, 2nd and 3rd year residents at the CDM
illustrated in Figure 1. Postdoctoral Periodontics Program (JW and GL), performed all
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1284 WANG et al.
surgeries under specialist faculty supervision (EL and PNP). Sites time (Figure S1). Radiographic files were de-identified with respect
were anaesthetized with 2% lidocaine/1:100,000 epinephrine via to patient, treatment allocation and time point and forwarded to
local infiltration. After full-thickness flap elevation, the osteotomy an oral radiologist at the University of Göteborg, Sweden, who car-
was prepared, and cortical and/or screw tap drills were used at the ried out bone level assessments at the mesial and distal surface of
surgeon's discretion based on bone quality, as per the manufacturer's each implant in a blinded fashion. Adobe Illustrator CC was used to
guidelines. Implant placement (NobelParallel Conical Connection, mark the distance from the implant's most coronal and widest part
Nobel Biocare AB) was carried out with the intent to position the to the marginal bone level along the implant surface (Figure 3). This
implant platform flush with the most apical portion of alveolar crest. distance was converted into millimetres by comparing the radio-
After placement, an implant stability measuring device (Osstell®, graphically measured diameter against the actual implant diameter.
Osstell AB) was used to assess the implant stability quotient (ISQ) The measurements were forwarded back to the investigators at
value based on resonance frequency analysis, at four sites (mesial, CDM and re-associated with the patient study number and time
distal, buccal and lingual). ISQ measurements were obtained twice point.
and averaged per implant. A cover screw (Nobel Biocare AB) or a Secondary outcomes were clinical parameters assessed by two
temporary abutment (Nobel Biocare AB) was placed on implants calibrated examiners (JW and GL) using a UNC-15 probe at six sites
temporized in a delayed or immediate fashion, respectively. Simple per implant, and included probing depth (in mm), bleeding on probing
interrupted 4–0 chromic gut sutures were placed, and patients were and plaque levels (yes/no) at 6 and 12 months. Peri-implant muco-
prescribed amoxicillin 875 mg BID for one week and ibuprofen sal margin levels were measured from a custom-made, pre-fabri-
600 mg, for pain as needed. Participants in the IM group received cated individual thermoplastic stent at temporization, and at 6 and
a temporary crown on the same day, fabricated under supervision 12 months (Figure S2). A second set of ISQ values were obtained at
by a specialist in Prosthodontics (NB). The temporary crowns were the time of delivery of the final prosthesis.
fabricated using auto-polymerized polymethyl methacrylate (Alike,
GC America) and a titanium temporary abutment (Nobel Biocare).
Participants in the DEL treatment arm underwent a second surgery 2.6 | Statistical analyses
at 3 months to remove the cover screw and insert a healing abut-
ment (Nobel Biocare AB), followed by fabrication of a temporary Changes in peri-implant bone level from baseline to 6 and 12 months
crown 1 week later. Temporary crowns, regardless of randomization (Figure S3) were computed, along with changes in clinical parame-
group, were screw-retained without occlusal contacts. In both arms, ters over time (probing depths, bleeding on probing, plaque, ISQ and
the final prosthesis, a monolithic zirconia screw-retained implant level of peri-implant mucosal margin).
crown with angulated screw channel (NobelProcera FCZ implant Baseline characteristics and outcomes were reported as mean
crown; Nobel Biocare AB), was delivered at 5 months post-surgery with standard deviation or median with first quartile and third
and torqued to 35 Ncm (Figure 2). quartile for continuous variables, and count with percentages for
categorical variables by treatment arms. T test, Kruskal–Wallis test
and Fisher's exact test were conducted as appropriate. Two sepa-
2.5 | Data collection rate random intercept models were fitted to assess the effect of
treatment arm (IM or DEL) on changes in peri-implant bone level
Standardized periapical digital radiographs were obtained at im- from baseline to 6 months or from baseline to 12 months, adjusting
plant placement (baseline), 6 and 12 months, using a long-cone for potential confounders. Mesial/distal surface was nested within
technique and a custom-fabricated stent made of polyvinyl silox- patients and was treated as a random effect, and an autoregressive
ane bite registration material (Futar D Bite Registration Material, correlation structure was used to account for the correlated nature
Kettenbach) to achieve reproducible radiographic geometry over of the data.
F I G U R E 2 Clinical example of
temporization and final restoration. (a)
Pre-operative. (b) After temporization. (c)
(a) (b) (c)
After final crown delivery
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WANG et al. 1285
3 | R E S U LT S in approximately 65% of the DEL sites and 44% of the IM sites

(p = .350). A cortical drill was used in 87% of the DEL and 73% of
3.1 | Study sample the IM surgical sites (p = .299), and screw tap was used in 32% of the
DEL and 46% of the IM sites (p = .382). Of the 49 implants, 4.3 mm
Forty-nine of the randomized 52 patients—26 in the IM and 23 in the diameter regular platform implants comprised approximately 70% of
DEL group—completed the 12-month follow-up and were included those in the DEL treatment arm compared to 58% in the IM arm
in final analyses (Figure 1a); one patient in each treatment arm was (p = .517; Table S1). Final insertion torque values ranged from 5
unreachable after the surgical appointment, and a second patient to 50 Ncm (Figure S4) with a median of 45 Ncm in both the DEL
in the DEL group moved to another city and was unable to attend and IM groups. Approximately 8% of all implants required use of a
follow-up visits. bone graft (Creos allograft, Nobel Biocare AB) at the time of implant
Table 1 describes baseline demographic characteristics of the 49 pa- placement to cover buccal plate dehiscences. A median increase in
tients who completed the study. Their mean age was 46.8 ± 10.7 years ISQ from surgery to final crown delivery of 3.4 units (Q1-Q3: 0.6,
(range 25–70 years), and approximately 69% of the participants were 4.65) was noted in the DEL group, and of 2.2 units (Q1-Q3: −1.2, 5.7)
female. Two participants reported controlled diabetes and 5 reported in the IM arm (p = .7046; Figures S5 and S6).
controlled hypertension. Only one participant was a current smoker
(<10 cigarettes/day). No statistically significant differences were ob-
served in these variables between the treatment arms. 3.3 | Primary outcome: Radiographic bone level
change over time
3.2 | Site distribution and surgical covariates In both IM and DEL arms, a reduction in peri-implant bone support
was noted between baseline and 6 months after implant placement,
Table 2 shows that 57% of the edentulous spaces treated were molar while bone levels appeared to stabilize between 6 and 12 months.
sites and 55% maxillary sites. Type 3 bone density was observed While the differences in longitudinal bone level change between the
arms did not reach statistical significance (p = .297), implants in the
DEL group displayed a mean reduction in bone support of 1.6 mm
over 1 year, compared to a reduction of 1.2 mm in the IM group
when averaging values at mesial and distal surfaces (Table 3).
3.4 | Secondary outcomes
Comparisons of peri-implant probing depth (PD), plaque and bleed-

ing on probing (BOP) at various time points between the two treat-
ment arms are shown in Table S2. Only the average maximum PD
differed statistically between the arms (3.40 ± 1.05 mm in the DEL
group, 2.83 ± 0.82 mm in the IM group, p = .050), and no statistically
significant differences emerged for any of the remaining parameters.
A slight apical shift in the level of the peri-implant mucosal margin
was noted in the IM arm over time, while the soft tissue in the DEL
arm migrated to a coronal direction. However, these differences did
not reach statistical significance (Table S3).
3.5 | Regression analysis
The two random intercept models that examined the effect of

treatment arm allocation on bone level changes from baseline to
6 months and from baseline to 12 months also included final inser-
tion torque and implant diameters as covariates (Table S4). No statis-
tically significant effects of treatment allocation were detected for
either the short-term (p = .114) or the long-term (p = .265) bone level
F I G U R E 3 Reference points for the assessment of peri-implant
radiographic bone level. Green dots mark the implant platform. Red change. Likewise, no significant effects of the examined covariates
dots mark the most coronal level of supporting bone were noted.
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1286 WANG et al.
TA B L E 1 Study participant
Delayed Immediate Total analysed
* characteristics
(n = 23) (n = 26) (n = 49) P-value
Age
Mean (SD); years 48.8 (11.1) 45.1 (10.3) 46.8 (10.7) .236
Range 31–70 25–63 25–70
Sex
Male 7 (30.4%) 8 (30.8%) 15 (30.6%) .999
Female 16 (69.6%) 18 (69.2%) 34 (69.4%)
Ethnicity
Hispanic 9 (39.1%) 11 (42.3%) 20 (40.8%) .999
Non-Hispanic 8 (34.8%) 8 (30.8%) 16 (32.7%)
Not reported 6 (26.1%) 7 (26.9%) 13 (26.5%)
Diabetes
No diabetes 22 (95.7%) 25 (96.2%) 47 (95.9%) .999
Controlled diabetes 1 (4.3%) 1 (3.8%) 2 (4.1%)
Hypertension
No hypertension 20 (87.0%) 24 (92.3%) 44 (89.8%) .655
Controlled 3 (13.0%) 2 (7.7%) 5 (10.2%)
hypertension
Smoking
No smoking 23 (100.0%) 25 (96.2%) 48 (98.0%) .999
Current smoker, <10 0 (0%) 1 (3.8%) 1 (2.0%)
cig./day
*Fisher's exact test or t test was conducted as appropriate.
3.6 | Protocol deviations and adverse events Therefore, given the difficulty to conceal the treatment allocation
from the surgeon when the patient was inevitably aware, the de-
Forty-eight of 49 implants in the study were restored as originally cision was made to prepare all osteotomies, irrespective of treat-
planned using monolithic zirconia screw-retained implant crowns, ment allocation, aiming at a ≥30 Ncm final insertion torque, that
with angulated screw channels. One protocol deviation occurred is the minimal torque required for immediate temporization. This
because of a single crown that was cement-retained due to exces- was also deemed necessary to avoid abandonment of the pre-allo-
sive angulation. No adverse events—such as crown fracture, screw cated treatment post-randomization, in cases of poor-quality bone
loosening or implant removal/failure—occurred within the study randomized to the immediate temporization arm. As illustrated in
period. Figure S4, a ≥30 Ncm torque was indeed achieved in all but four pa-
tients. Thus, by avoiding over-preparation of osteotomies, as if all
fixtures were destined for immediate temporization, we prevented
4 | D I S CU S S I O N potential bias due to minor but systematic changes in the surgical
protocol between the two arms. Likewise, the two surgeons strived
We conducted an RCT to examine whether immediately tempo- to place all implants flush with the bone, although this was not
rized single implants at posterior sites exhibit different clinical achievable at all occasions, given that edentulous ridges are often
outcomes at 12 months than implants submerged and temporized irregular. Nevertheless, we purposefully avoided sub-crestal posi-
3 months later. Our findings show that patterns of bone and soft tioning of the implant platform, common in clinical practice when
tissue re-modelling were largely similar in both groups and that increased initial torque is desirable for immediate temporization.
most of the bone level changes occurred within the first 6 months Platform position in relation to the bone crest, and the associated
post-placement. location of the microgap, has been shown to profoundly influence
Some important details in the study procedures need to be the longitudinal re-modelling of peri-implant crestal bone that can
appreciated. Although patients were randomly assigned to either resorb up to 2 mm (Oh, Yoon, Misch, & Wang, 2002). A non-sub-
the IM or DEL groups, logistical issues related to patient sched- merged position of the implant platform was indeed achieved in
uling (i.e. allocation of shorter, surgical-only appointments or of both the DEL and IM treatment arms, with average bone level
longer appointments to accommodate same-day provisionaliza- values indicating a slightly supra-crestal location, by 0.05 and
tion) precluded the conduct of the trial in a double-blinded fashion. 0.04 mm, respectively (Figure S7).
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WANG et al. 1287
TA B L E 2 Surgical site distribution and

Delayed Immediate Total analysed
surgical covariates
(n = 23) (n = 26) (n = 49) P-value*
Surgical site
Premolar 9 (39.1%)a 12 (46.2%) 21 (42.9%) .774
Molar 14 (60.9%) 14 (53.8%) 28 (57.1%)
Arch
Maxilla 13 (56.5%) 14 (53.8%) 27 (55.1%) .999
Mandible 10 (43.5%) 12 (46.2%) 22 (44.9%)
Bone density
Not reported 0 1 1 .350
Type 1 0 (0.0%) 2 (8.0%) 2 (4.2%)
Type 2 3 (13.0%) 6 (24.0%) 9 (18.8%)
Type 3 15 (65.2%) 11 (44.0%) 26 (54.2%)
Type 4 5 (21.7%) 6 (24%) 11 (22.9%)
Cortical drill used
Yes 20 (87.0%) 19 (73.1%) 39 (79.6%) .299
No 3 (13.0%) 7 (26.9%) 10 (20.4%)
Screw tap used
Not reported 1 0 1 .382
Yes 7 (31.8%) 12 (46.2%) 19 (39.6%)
No 15 (68.2%) 14 (53.8%) 29 (60.4%)
Implant diameter
3.75 mm 1 (4.3%) 4 (15.4%) 5 (10.2%) .517
4.3 mm 16 (69.6%) 15 (57.7%) 31 (63.3%)
5.0 mm 6 (26.1%) 7 (26.9%) 13 (26.5%)
Final torque
Mean Ncm (SD) 39.1 (14.5) 43.1 (7.1) 41.2 (11.3) .801
Median Ncm (Q1, 45 (30, 50) 45 (35, 50) 45 (35, 50)
Q3)
Range Ncm 5–50 30–50 5–50
Bone graft at implant placement
No 21 (91.3%) 24 (92.3%) 45 (91.8%) .999
Yes 2 (8.7%) 2 (7.7%) 4 (8.2%)
a
Percentages in parentheses denote column %.
*Fisher's exact test or Kruskal–Wallis test was conducted as appropriate.
TA B L E 3 Primary outcome: Bone level change over time (mm)
Baseline to 6 months
Delayed Immediate P-value*
Mesial Distal Mesial Distal Mesial Distal
Mean (SD) 1.85 (1.16) 1.82 (0.76) 1.26 (1.10) 1.36 (1.27) .088 .165
Median (Q1, Q3) 1.67 (1.16, 2.58) 1.81 (1.71, 2.14) 1.35 (0.31, 2.11) 1.46 (0.56, 2.07) .142 .118
Delayed Immediate P-value
Mesial Distal Mesial Distal Mesial Distal
Mean (SD) 1.57 (1.17) 1.60 (0.88) 1.14 (1.20) 1.22 (1.40) .235 .297
Median (Q1, Q3) 1.54 (0.99, 2.12) 1.66 (1.19, 2.19) 1.10 (0.09, 2.26) 0.98 (0.64, 2.14) .349 .192
*T test or Kruskall–Wallis test, as appropriate.

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1288 WANG et al.
TA B L E 4 Primary outcome: Frequency distribution of bone level change over time
Delayed Immediate P-value*
Bone level changea Mesial Distal Mesial Distal Mesial Distal
Unreadable 2 3 2 4
(−2mm,−1mm] 0 (0.0%) 0 (0.0%) 1 (4.2%) 0 (0.0%) .434 .143
(−1mm, 0mm] 2 (9.5%) 1 (5.0%) 2 (8.3%) 4 (18.2%)
(0mm, 1mm] 1 (4.8%) 1 (5.0%) 6 (25.0%) 5 (22.7%)
(1mm, 2mm] 9 (42.9%) 11 (55.0%) 7 (29.2%) 6 (27.3%)
(2mm, 3mm] 6 (28.6%) 6 (30.0%) 7 (29.2%) 4 (18.2%)
(3mm, 4mm] 2 (9.5%) 1 (5.0%) 1 (4.2%) 3 (13.6%)
(4mm, 5mm] 1 (4.8%) 0 (0.0%) 0 (0.0%) 0 (0.0%)

Bone level
change Mesial Distal Mesial Distal Mesial Distal
Unreadable 2 2 1 3
(−2mm, −1mm] 0 (0.0%) 0 (0.0%) 1 (4.0%) 1 (4.3%) .515 .188
(−1mm, 0mm] 2 (9.5%) 1 (4.8%) 4 (16.0%) 4 (17.4%)
(0mm, 1mm] 4 (19.0%) 4 (19.0%) 6 (24.0%) 7 (30.4%)
(1mm, 2mm] 8 (38.1%) 9 (42.9%) 5 (20.0%) 5 (21.7%)
(2mm, 3mm] 5 (23.8%) 6 (28.6%) 9 (36.0%) 2 (8.7%)
(3mm, 4mm] 1 (4.8%) 1 (4.8%) 0 (0.0%) 3 (13.0%)
(4mm, 5mm] 1 (4.8%) 0 (0.0%) 0 (0.0%) 1 (4.3%)
6 to 12 months

Bone level
change Mesial Distal Mesial Distal Mesial Distal
Unreadable 1 2 1 1
(−3mm, −2mm] 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (4.0%) .800 .397
(−2mm, −1mm] 4 (18.2%) 2 (9.5%) 3 (12.0%) 1 (4.0%)
(−1mm, 0mm] 12 (54.5%) 11 (52.4%) 12 (48.0%) 12 (48.0%)
(0mm, 1mm] 5 (22.7%) 6 (28.6%) 9 (36.0%) 11 (44.0%)
(1mm, 2mm] 1 (4.5%) 2 (9.5%) 1 (4.0%) 0 (0.0%)
a
Positive values denote reduction in bone support over time, and negative values denote bone apposition.
*Fisher's exact test.
Adequate insertion torque remains the benchmark upon which Helms, and Brunski (2019) further support the notion that high
a decision for immediate or delayed provisionalization is made in insertion torque may be associated with peri-implant bone dam-
clinical practice. While this is commonly accomplished by delib- age. However, other studies did not corroborate these observa-
erately under-sizing the osteotomy, the impact of the resulting tions and reported that high insertion torques (as high as 176 Ncm)
increase in bone strain on osseous re-modelling remains controver- did not result in unfavourable cortical bone re-modelling (Consolo,
sial. Barone et al. (2016) showed that high (≥50 Ncm) final insertion Travaglini, Todisco, Trisi, & Galli, 2013; Grandi, Guazzi, Samarani,
torque resulted in more bone re-modelling than that observed in & Grandi, 2013; Khayat, Arnal, Tourbah, & Sennerby, 2013; Trisi,
implants placed with lower torque. In an animal study using strain Todisco, Consolo, & Travaglini, 2011). Although all implants in
gauges, Duyck et al. (2010) reported that torque above 50 Ncm led this study—regardless of treatment arm—were placed aiming at a
to excessive strain of the marginal bone and may induce bone loss. 30–45 Ncm insertion torque, a 50 Ncm final torque was measured
Additional studies by Cha et al. (2015) and Monje, Ravidà, Wang, in 21 of 49 implants (43%; Figure S4), which slightly exceeds the
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WANG et al. 1289
maximum threshold recommended by the manufacturer. While microgap at the abutment/fixture interface and contribute to bone
the regression model showed no statistically significant impact of loss (Oh et al., 2002).
insertion torque on bone level change, implants placed with high Most published literature on osseous re-modelling patterns
torque exhibited a wide range of bone change values (Figure S8). according to provisionalization schemes have reported no signifi-
Therefore, it remains plausible that insertion torque may partly cant difference in bone level changes between immediate and de-
account for the rapid bone re-modelling observed, and additional layed loading groups (Benic, Mir-Mari, & Hämmerle, 2014; Gjelvold
studies are clearly needed to further substantiate the relationship et al., 2017; Imburgia & Fabbro, 2015; Meloni, De Riu, Pisano, De
of insertion torque, bone strain and longitudinal peri-implant bone Riu, & Tullio, 2012). The non-statistically significant more favourable
re-modelling. bone re-modelling noted in the IM group may either represent ran-
Classical literature suggests that implants are expected to expe- dom variation, or may be the result of lack of power to detect a true,
rience approximately 1.5 mm of bone re-modelling during the first underlying difference between the treatment arms. It is important
year after final prosthesis delivery, followed by less than 0.2 mm of to recognize that published studies have generally not adequately
bone loss annually thereafter (Adell, Lekholm, Rockler, & Brånemark, accounted for variation due to functioning versus non-functioning
1981; Albrektsson, Zarb, Worthington, & Eriksson, 1986; Cox & Zarb, immediate provisionals. Furthermore, an immediate provisional with
1987). For implant designs with polished necks and no micro-threads no occlusal contacts may still entail risk for excessive implant mi-
to the top, the expected location of the osseous support after loading cromotion during daily function. Although a micromotion of 100-
is the implant's first thread (Jung, Han, & Lee, 1996). In the context of 150 µm is tolerable during healing, risk of fibrous encapsulation
bone re-modelling with respect to loading protocols, Gjelvold, Kisch, increases when forces exceed this threshold. However, other stud-
Chrcanovic, Albrektsson, and Wennerberg (2017) reported an approx- ies suggest that a certain amount of force during immediate loading
imate average of 0.5 mm of bone re-modelling in an apical direction may indeed aid in bone deposition (Schincaglia, Marzola, Giovanni,
for both delayed- and immediately loaded implants at 6 months, out of Chiara, & Scotti, 2008).
the total average of 0.7 mm at 12 months. In an 11-year follow-up of The strengths of the present RCT include its generalizability, as
immediately loaded implants placed in mostly healed extraction sites, enrolled patients received single implants at premolar and molar sites
Glauser (2016) reported that out of an average total of 1.66 mm bone in both the maxilla and mandible. The randomization scheme was
level change over the entire study length, a mean change of 1.16 mm stratified by sex, dental arch and tooth type in order to account for ef-
occurred during the first year of loading. Thus, our observation of a fects by confounders. Study limitations include the non-feasibility of
bi-phasic pattern of re-modelling (an early accelerated phase followed a double-blinded design, the small sample size that may have impaired
by a relatively quiescent phase) is in accordance with the literature, al- power to detect more subtle differences in clinical outcomes and
though the average magnitude of the change in the DEL arm (1.83 mm the short follow-up time. Data obtained beyond the one-year period
at 6 months, 1.58 mm at 12 months, Table 3) is higher than expected. would provide valuable information about longer-term tissue stability.
Likewise, the distribution of bone level change values (Table 4) indi-
cates larger than expected (i.e. >2 mm) reduction in osseous support in AC K N OW L E D G E M E N T S
a substantial proportion of the implants: 9/23 implants in the delayed We would like to thank oral radiologist Dr. Agneta Lith, Sahlgrenska
group and 8/26 implants in the immediate group at 6 months, and 7/23 Academy, University of Göteborg, Sweden, for measuring radio-
and 9/26 implants in the respective groups at 12 months. The reasons graphic bone levels, and Ms. Romanita Celenti, College of Dental
for this discrepancy with the published literature are currently unclear. Medicine, Columbia University, for serving as the study coordinator.
Periosteal elevation and surgical trauma are known to result in bone
loss around teeth (Donnenfeld, Hoag, & Weissman, 1970; Ramfjord C O N FL I C T O F I N T E R E S T
& Costich, 1968; Wildermann, Pennel, King, & Barron, 1970) and im- The authors declare no conflicts of interest.
plants (Adell et al., 1981). However, these universal factors were obvi-
ously not unique to our study and cannot account for the higher than ORCID
expected bone re-modelling observed. Joseph Wang https://orcid.org/0000-0002-8346-5318
Violation of the peri-implant mucosal seal, especially in the DEL Evanthia Lalla https://orcid.org/0000-0002-1074-7031
group that underwent a second stage procedure, may also have neg- Panos N. Papapanou https://orcid.org/0000-0002-6538-3618
atively affected stability of peri-implant marginal bone. Repeated
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https://doi.org/10.1097/01.id.0000246248.55038.3a

J Clinic Periodontology - 2020 - Wang - Immediate Versus Delayed Temporization at Posterior Single Implant Sites A

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Received: 24 April 2020 | Revised: 22 June 2020 | Accepted: 28 July 2020

ORIGINAL ARTICLE IMPL ANT DENTISTRY

Immediate versus delayed temporization at posterior single

dental prostheses, loading, partial edentulism, prospective, provisionalization

ClinicalTrials.gov (ID NCT02387970).

J Clin Periodontol. 2020;47:1281–1291. ﻿ wileyonlinelibrary.com/journal/jcpe | 1281

restoration without sacrificing aesthetics (Gjelvold, Sohrabi, &

FIGURE 1 (a) Enrolment flow diagram. (b) Study timeline

3 | R E S U LT S in approximately 65% of the DEL sites and 44% of the IM sites

3.4 | Secondary outcomes

Comparisons of peri-implant probing depth (PD), plaque and bleed-

3.5 | Regression analysis

The two random intercept models that examined the effect of

*Fisher's exact test or t test was conducted as appropriate.

TA B L E 2 Surgical site distribution and

TA B L E 3 Primary outcome: Bone level change over time (mm)

Delayed Immediate P-value*

Mesial Distal Mesial Distal Mesial Distal

Delayed Immediate P-value

Mesial Distal Mesial Distal Mesial Distal

*T test or Kruskall–Wallis test, as appropriate.

TA B L E 4 Primary outcome: Frequency distribution of bone level change over time

Delayed Immediate P-value*

Bone level changea Mesial Distal Mesial Distal Mesial Distal

Delayed Immediate P-value

Delayed Immediate P-value

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J Clin Periodontol. 2020;47:1281–1291. wileyonlinelibrary.com/journal/jcpe | 1281