CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Hard tissue augmentation at the buccal aspect of single implants. +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05143242
NCT05143242N/ACompleted

A Randomized Controlled Trial Comparing Guided Bone Regeneration With Connective Tissue Graft to Re-establish Buccal Convexity at Implant Sites: Three-year Results.

University Ghent·interventional·Posted Dec 3, 2021·Updated Dec 3, 2021

In Brief

A clinical study evaluating Hard tissue augmentation at the buccal aspect of single implants. and Soft tissue augmentation at the buccal aspect of single implants. for Guided Bone Regeneration. Completed, enrolled 42 participants.

Detailed Summary

The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction. A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal. An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used. The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2021
Enrollment StartMar 1, 2015
Primary CompletionMar 1, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 4.6 years ago

Interventions

Hard tissue augmentation at the buccal aspect of single implants.procedure

One or two releasing incisions are made. The periosteum is released and multiple bone perforations are made in the buccal bone prior to the application of deproteinized bovine derived xenograft. A Creos® membrane (Nobel Biocare, Gothenburg, Sweden) is used to cover the occlusal part of the alveolar crest and the xenograft particles. Finally, multiple single monofilament sutures are used for primary tension-free wound closure.

Soft tissue augmentation at the buccal aspect of single implants.procedure

A CTG is taken from the palate and transplanted to the buccal side between the alveolar bone and the buccal flap. The CTG is secured with single monofilament sutures.