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

Primary Purpose

Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa, Thin Gingiva

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
Free Gingival graft
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Attached mucosa, Keratinized tissue, Dental implants, Connective tissue

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unversity of Alabama at Birmingham, School of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)

Free gingival graft.

Arm Description

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 recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations. A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.

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 will be 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.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2021
Last Updated
October 17, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04920136
Brief Title
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Official Title
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Lack of Keratinized Attached Peri-implant Mucosa, Thin Gingiva
Keywords
Attached mucosa, Keratinized tissue, Dental implants, Connective tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
Arm Type
Experimental
Arm Description
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 recipient site should ideally retain intact periosteum that is firmly attached to bone with no loose fibers, no irregularities and no perforations. A strip of a free gingival graft is then harvested from the patient's palate. This strip is only 2 to 3 mm wide ,1 to 1.5 mm thick and has an appropriate length to cover the full apical extension of the recipient site. The strip is sutured immediately with 6-0 monocryl sutures. Coronal to the strip, the periosteal bed is covered with ADM, which is already rehydrated in sterile saline for 10 min, trimmed and customized to fit the available space. The ADM is then stabilized on the periosteal bed with the epithelium side facing upward. The ADM is fixed on the recipient bed by periosteal 6-0 monocryl sutures.
Arm Title
Free gingival graft.
Arm Type
Active Comparator
Arm Description
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 will be 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.
Intervention Type
Procedure
Intervention Name(s)
Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Free Gingival graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of soft tissue regenerated
Description
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)
Time Frame
From baseline to 12 months
Title
Quantity of soft tissue regenerated (Width of Keratinized Tissue)
Description
Using a periodontal probe , the width of keratinized tissue will be measured in (mm) and compared between two grafts used.
Time Frame
From baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hussein Basma, DDS, MS
Phone
2059344506
Email
basma86@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Startley, DMD
Phone
2059758711
Email
ss1971@uab.edu
Facility Information:
Facility Name
Unversity of Alabama at Birmingham, School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hussein Basma, DDS, MS
Phone
205-975-2888
Email
basma86@uab.edu
First Name & Middle Initial & Last Name & Degree
Sarah Startley, DMD
Phone
205-975-8711
Email
ss1971@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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