Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Immediate implant Immediate implant alone |
Device: Immediate implant
|
| Active Comparator: Immediate implant combined with SCTG Subepithelial connective tissue graft (SCTG) |
Device: Immediate implant
Biological: SCTG
|
| Active Comparator: Immediate implant combined with ADM Acellular dermal matrix (ADM) |
Device: Immediate implant
Biological: ADM
|
Outcome Measures
Primary Outcome Measures
- Change in ridge dimensional alteration [baseline, 6 months after surgery]
- Change in ridge dimensional alteration [baseline, 12 months after surgery]
Secondary Outcome Measures
- Change in gingival level [baseline, 6 months after surgery]
- Change in gingival thickness [baseline, 6 months after surgery]
- Change in width of keratinized gingiva [baseline, 6 months after surgery]
- Change in alveolar bone level [baseline, 6 months after surgery]
- Change in bone dimension [baseline, 6 months after surgery]
Eligibility Criteria
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).
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level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Chun-Teh Lee, DDS, DMSc, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-DB-16-0286