Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation

The University of Texas Health Science Center, Houston1 site in 1 country46 target enrollmentOctober 2016

ConditionsDental Implant Immediate Dental Implant Soft Tissue Augmentation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Dental Implant
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 46
Locations: 1
Primary Endpoint: Change in Ridge Dimension
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2016

End Date

November 22, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Chun-Teh Lee

Assistant Professor

The University of Texas Health Science Center, Houston

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.
•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.

Outcomes

Primary Outcomes

Change in Ridge Dimension

Time Frame: baseline, 12 months after surgery

Change in ridge dimension is calculated as the value at 12 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 12 months, models were made from these impressions, the models were scanned, and then ridge dimension of scanned models was assessed using software. Ridge dimension was assessed at (and at 1mm increments below) the initial soft tissue margin.