Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2021
CompletedResults Posted
Study results publicly available
December 16, 2022
CompletedDecember 16, 2022
November 1, 2022
5.1 years
August 9, 2016
November 21, 2022
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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 (Marginal)
baseline, 6 months after surgery
Change in Alveolar Bone Level (Crestal)
baseline, 6 months after surgery
- +1 more secondary outcomes
Study Arms (3)
Immediate implant
ACTIVE COMPARATORImmediate implant alone
Immediate implant combined with SCTG
ACTIVE COMPARATORSubepithelial connective tissue graft (SCTG)
Immediate implant combined with ADM
ACTIVE COMPARATORAcellular dermal matrix (ADM)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Related Publications (1)
Jung M, Tran D, Chang CC, Kim SK, Tsukiboshi Y, Min S, Ayilavarapu S, Lee CT. Volumetric buccal bone alterations at immediate implant sites with or without soft tissue augmentation: A 6-month assessment. J Periodontol. 2025 Aug 10. doi: 10.1002/jper.11381. Online ahead of print.
PMID: 40785129DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chun-Teh Lee
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Chun-Teh Lee, DDS, DMSc
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 12, 2016
Study Start
October 1, 2016
Primary Completion
November 22, 2021
Study Completion
November 22, 2021
Last Updated
December 16, 2022
Results First Posted
December 16, 2022
Record last verified: 2022-11