Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix

Gingival Recession Clinical Trial

Official title:

Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920136
• Other study ID #: IRB-300006910
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: Hussein Basma, DDS, MS
• Phone: 2059344506
• Email: basma86[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).

Description:

This investigation is a randomized controlled trial of two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM). To evaluate to determine if either grafting technique (FGG vs SGG+ADM) demonstrates superiority in clinical (amount of KT increase, tissue thickness increase, and practitioner-assessed esthetics) and patient-centered outcomes (pain, swelling, change in daily activities, and patient-assessed esthetics) in a controlled study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• English speaking

• At least 18 years old

• Able to read and understand informed consent document

• Patients with teeth/implants lacking keratinized tissue.

• Must be a patient of the UAB Dental School

• Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)

Exclusion Criteria:

• Non-English speaking

• Less than 18 years old

• Smokers/tobacco users (>10 cigarettes/day)

• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing

• Presence of active periodontal disease

• Previous soft tissue grafting at the site(s) to be treated

Related Conditions & MeSH terms

• Gingival Recession
• Thin Gingiva

Intervention

Procedure:
• Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
A horizontal incision is then placed at the middle of residual KT. Two vertical releasing incisions are followed to allow for apical displacement of the flap. The flap will be then elevated with a split-thickness flap beyond the mucogingival junction where it is sutured at this apical position using a mattress (5-0, monocryl) suture. The recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations.
• Free Gingival graft
Two vertical incisions are made, and a partial thickness flap are designed to provide a firm and immobile periosteal bed. The raised partial thickness flap will be excised. Muscle and unattached connective tissue fibers are thoroughly scraped with a scalpel to prevent graft mobility. Autogenous FGG was harvested with #15C scalpel blade from hard palate at the same side randomly selected to receive the FGG. Donor area was sutured with 5-0 gut sutures. FGG, is placed and stabilized with simple interrupted 5-0 vicryl sutures at recipient site coronal border and horizontal or periosteal anchorage sutures over the graft.

Locations

Country	Name	City	State
United States	Unversity of Alabama at Birmingham, School of Dentistry	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of soft tissue regenerated	Compare the change in soft tissue quality (attached or keratinized ) between two used soft tissue grafts by superimposing the before and after intraoral scans and the calculating using a software the difference of soft tissue gain between both scans in (mm)	From baseline to 12 months
Primary	Quantity of soft tissue regenerated (Width of Keratinized Tissue)	Using a periodontal probe , the width of keratinized tissue will be measured in (mm) and compared between two grafts used.	From baseline to 12 months