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Clinical Trials/NCT04920136
NCT04920136
Recruiting
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country20 target enrollmentSeptember 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
University of Alabama at Birmingham
Enrollment
20
Locations
1
Primary Endpoint
Quality of soft tissue regenerated
Status
Recruiting
Last Updated
9 months ago

Overview

Brief 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).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
September 17, 2021
End Date
June 30, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hussein Basma

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of soft tissue regenerated

Time Frame: From baseline to 12 months

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)

Quantity of soft tissue regenerated (Width of Keratinized Tissue)

Time Frame: From baseline to 12 months

Using a periodontal probe , the width of keratinized tissue will be measured in (mm) and compared between two grafts used.

Study Sites (1)

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