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CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
Phase 3 trial testing Allograft mucosal enhancement with dental implant in Dental Implant Failure Nos in 39 participants. Completed in 20 December 2022.
| Lead sponsor | University of Illinois at Chicago |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 25 August 2019 |
| Primary completion | 1 July 2022 |
| Estimated completion | 20 December 2022 |
| Sites | 1 location across United States |
University of Illinois at Chicago
18 and older, any sex, with Dental Implant Failure Nos. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning
| Group | Value | 95% CI |
|---|---|---|
| Implant With Prophylactic Allograft | 15.5 | ± 19 |
| Implant Without Prophylactic Allograft | 16.8 | ± 62 |
Implant survival at 12 months post implant surgery. Percentage of implants surviving after 12 months of placement
| Group | Value | 95% CI |
|---|---|---|
| Implant With Prophylactic Allograft | 100 | |
| Implant Without Prophylactic Allograft | 90 |
Marginal bone levels (in millimeters) as measured by radiographic translucency. Bone levels between implant/abutment interface and crest of the bone were measured at time of implant placement and at 12 months later. The negative sign in the results below indicates that there was bone loss in both groups.
| Group | Value | 95% CI |
|---|---|---|
| Implant With Prophylactic Allograft | -0.17 | ± 0.33 |
| Implant Without Prophylactic Allograft | -0.01 | ± 0.11 |
This measurement is for the vertical position of the gingival margin change based on superimposed 3D intraoral scans
| Group | Value | 95% CI |
|---|---|---|
| Implant With Prophylactic Allograft | 0.18 | ± 0.27 |
| Implant Without Prophylactic Allograft | 0.16 | ± 0.31 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing