Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Soft Tissue Augmentation; Immediate Dental Implant
• Intervention / Treatment: Device: Immediate implant; Biological: SCTG; Biological: ADM

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ridge Dimension	Change in ridge dimension is calculated as the value at 6 months minus the value at baseline. To take ridge dimension measurements, impressions were taken at baseline and 6 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.	baseline, 6 months after surgery
Change in Ridge Dimension	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.	baseline, 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Level	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.	baseline, 6 months after surgery
Change in Gingival Thickness	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.	baseline, 6 months after surgery
Change in Width of Keratinized Gingiva	Change in width of keratinized gingiva is calculated as the value at 6 months minus the value at baseline.	baseline, 6 months after surgery
Change in Alveolar Bone Level (Marginal)	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).	baseline, 6 months after surgery
Change in Alveolar Bone Level (Crestal)	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).	baseline, 6 months after surgery
Change in Bone Dimension	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).	baseline, 6 months after surgery

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): November 22, 2021
• Study Completion (ACTUAL): November 22, 2021

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (ESTIMATE): August 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HSC-DB-16-0286