CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Allograft mucosal enhancement with dental implant +1 moredevice
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/NCT04082143
NCT04082143Phase 3Completed

CATER: Comprehensive Alveolar and Tooth Esthetic Replacement

University of Illinois at Chicago·interventional·Posted Sep 9, 2019·Updated Feb 28, 2025

In Brief

A Phase 3 clinical trial evaluating Allograft mucosal enhancement with dental implant and No allograft mucosal enhancement at time of dental implant placement for Dental Implant Failure Nos. Completed, enrolled 39 participants across 1 site.

Detailed Summary

The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm\*) during dental implant therapy improves implant health and appearance. On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum graft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire. Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic at 1 year after implant placement for implant evaluation. At this final study appointment, x-rays and a 3D intraoral scan will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be assessed via bleeding upon probing and completion of a brief questionnaire, respectively.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 9, 2019
Enrollment StartAug 25, 2019
Primary CompletionJul 1, 2022
Study CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.8 years ago

Interventions

Allograft mucosal enhancement with dental implantdevice

implant placement with allograft mucosal enhancement

No allograft mucosal enhancement at time of dental implant placementdevice

implant placement without allograft mucosal enhancement