Phase 3
N=39
CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
Dental Implant Failure Nos
Bottom Line
View on ClinicalTrials.gov: NCT04082143 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning — 15.5; 16.8 percentage of volume change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Allograft mucosal enhancement with dental implant (Device); No allograft mucosal enhancement at time of dental implant placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning |
15.5; 16.8 | — |
| SECONDARY Percentage of Implant Survival |
100; 90 | — |
| SECONDARY Marginal Bone Levels (MBLs) |
-0.17; -0.01 | — |
| SECONDARY Vertical Tissue Change as Measured by 3D Intraoral Scanning |
0.18; 0.16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Willing and able to provide informed consent
- In need of one implant to replace a missing tooth
- At least 20 teeth in good repair and occlusion
- Sufficient bone volume for dental implant placement without required bone augmentation
- Site development (soft and/or bone tissue) performed at least 5 months before implant placement, when required
Exclusion Criteria
- Current smoker
- Implant cannot be placed without bone graft
- Unable to pay for crown
- Untreated rampant caries and/or uncontrolled periodontitis
- Absence of adjacent (mesial and/or distal) natural tooth
- Uncontrolled diabetes
- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- use of bisphosphonates
- History of radiation in the head and neck region
- Unable or unwilling to return for follow-up visits
- Unrealistic esthetic or functional demands
- Unlikely to be able to comply with study procedures
- Unwilling or unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT04082143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.