Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
NCT ID: NCT02864862
Last Updated: 2022-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
46 participants
INTERVENTIONAL
2016-10-31
2021-11-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate implant
Immediate implant alone
Immediate implant
Immediate implant combined with SCTG
Subepithelial connective tissue graft (SCTG)
Immediate implant
SCTG
Immediate implant combined with ADM
Acellular dermal matrix (ADM)
Immediate implant
ADM
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate implant
SCTG
ADM
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chun-Teh Lee
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chun-Teh Lee, DDS, DMSc
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC-DB-16-0286
Identifier Type: -
Identifier Source: org_study_id