Phase 4
N=46
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Dental Implant · Immediate Dental Implant · Soft Tissue Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT02864862 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Change in Ridge Dimension — -1.65; -1.87; -1.44; -1.37 millimeters (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Immediate implant (Device); SCTG (Biological); ADM (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ridge Dimension |
-1.80; -2.33; -1.91; -1.21; -1.61; -1.54 | — |
| PRIMARY Change in Ridge Dimension |
-1.80; -2.33; -1.91; -1.21; -1.61; -1.54 | — |
| SECONDARY Change in Gingival Level |
-0.47; -0.9; -0.67; 0.2; -0.37; 0.3 | — |
| SECONDARY Change in Gingival Thickness |
0.86; 0.97; 0.14 | — |
| SECONDARY Change in Width of Keratinized Gingiva |
0.27; -0.47; 0.37 | — |
| SECONDARY Change in Alveolar Bone Level (Marginal) |
-0.45; -0.70; -0.37; -0.19; -0.27; -0.40 | — |
| SECONDARY Change in Alveolar Bone Level (Crestal) |
-0.62; -0.35; -0.43; -0.88; -0.74; -0.78 | — |
| SECONDARY Change in Bone Dimension |
-1.34; -0.85; -0.77; -1.74; -1.40; -1.33 | — |
Summary
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.
Eligibility Criteria
Inclusion Criteria
- patients who are in need of a tooth extraction at the maxillary premolar, canine and incisor region, and subsequent single implant placement.
- The reasons for extraction will include poor endodontic prognosis and/or unrestorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, root perforation, root resorption with or without radiographic periapical lesion up to 3 mm in diameter). patients who are systemically healthy or with controlled common systemic conditions (controlled hypertension, controlled diabetes HbA1c up to 7 %).
- adjacent teeth have to be present and the eligible tooth has esthetically acceptable buccal gingival margin position prior to surgery, compared to neighboring teeth and contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).
- level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
- Location of buccal alveolar crest has to be generally within 4 mm from the free gingival margin, verified after the extraction, before randomization; and fenestration, if present, up to 3mm in diameter at the apical part of the root and affecting less than 30% of the buccal socket wall.
Exclusion Criteria
- currently smoke exceeding 10 cigarettes/ day
- severe parafunctional habits, malocclusion or intent of orthodontic therapy in the future and are pregnant.
- teeth in the surgical site will be excluded if there is advanced periodontal disease or periapical lesion causing significant bony defects that are beyond the criteria mentioned at Section 3.3.
- allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin, polymixin B and Vancomycin) will not be included in the immediate implant combined with ADM group.
Data sourced from ClinicalTrials.gov (NCT02864862). 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.