Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Soft Tissue Augmentation; Immediate Dental Implant; Dental Implant

Treatments: Biological: ADM; Biological: SCTG; Device: Immediate implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02864862

HSC-DB-16-0286

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 3 patient groups

Immediate implant

Active Comparator group

Description:

Immediate implant alone

Treatment:

Device: Immediate implant

Immediate implant combined with SCTG

Active Comparator group

Description:

Subepithelial connective tissue graft (SCTG)

Treatment:

Biological: SCTG

Device: Immediate implant

Immediate implant combined with ADM

Active Comparator group

Description:

Acellular dermal matrix (ADM)

Treatment:

Biological: ADM

Device: Immediate implant