Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation

Phase 4

Completed

Conditions: Dental Implant
Immediate Dental Implant
Soft Tissue Augmentation

Interventions: Device: Immediate implant
Biological: SCTG
Biological: ADM

Registration Number: NCT02864862

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant combined with SCTG	SCTG	Subepithelial connective tissue graft (SCTG)
Immediate implant combined with SCTG	Immediate implant	Subepithelial connective tissue graft (SCTG)
Immediate implant	Immediate implant	Immediate implant alone
Immediate implant combined with ADM	Immediate implant	Acellular dermal matrix (ADM)
Immediate implant combined with ADM	ADM	Acellular dermal matrix (ADM)

Primary Outcome Measures

Name	Time	Method
Change in Ridge Dimension	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.

Secondary Outcome Measures

Name	Time	Method
Change in Alveolar Bone Level (Crestal)	baseline, 6 months after surgery	Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).
Change in Gingival Level	baseline, 6 months after surgery	Change in gingival level is calculated as the value at 6 months minus the value at baseline. Gingival level is measured at three sites: mesial, mid-buccal and distal sites. Gingival level is measured from a notch on a custom fabricated stent to the mucosal margin.
Change in Gingival Thickness	baseline, 6 months after surgery	Change in gingival thickness is calculated as the value at 6 months minus the value at baseline. Gingival thickness is measured using a stoppered endodontic file (#30) penetrating through the facial soft tissue 3 millimeters (mm) below the mid-buccal peri-implant mucosal margin.
Change in Bone Dimension	baseline, 6 months after surgery	Change in bone dimension is calculated as the value at 6 months minus the value at baseline. To measure bone dimensions, bone dimensions on cone beam computed tomography (CBCT) images were assessed using software. Bone dimension was assessed at the initial buccal crestal bone level (and at 1mm increments below).
Change in Width of Keratinized Gingiva	baseline, 6 months after surgery	Change in width of keratinized gingiva is calculated as the value at 6 months minus the value at baseline.
Change in Alveolar Bone Level (Marginal)	baseline, 6 months after surgery	Change in alveolar bone level is calculated as the value at 6 months minus the value at baseline. The bone level measurement, taken from the standardized periapical radiographs, was defined as the distance from the first bone to implant contact (IB) at either the mesial or the distal aspect of the implant to the implant platform. Specifically, marginal bone level was defined as the distance between the vertical implant bone level (IB; the first bone to implant contact) and implant platform (IP). Crestal bone level was defined as the distance between the interproximal crestal bone level (IC) and implant platform (IP).