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Grafting
Gingival Grafting Techniques for Gum Recession
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
Patients with teeth/implants lacking keratinized tissue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 months
Awards & highlights
Study Summary
This trial is comparing two techniques to improve the quality of tissue lacking keratinization, either through soft tissue grafting with autogenous material or strip gingival grafting with acellular dermal matrix.
Who is the study for?
This trial is for patients at the UAB Dental School, over 18 years old, who can understand consent forms and speak English. They should have healthy teeth or implants next to areas lacking keratinized tissue but no active gum disease, previous grafts in those areas, systemic conditions affecting healing, or heavy tobacco use.Check my eligibility
What is being tested?
The study compares two methods of increasing keratinized tissue around teeth and implants: one using a patient's own gum tissue (Free Gingival Graft) and another combining this with an Acellular Dermal Matrix (Strip Gingival Graft + ADM).See study design
What are the potential side effects?
Possible side effects may include discomfort at the graft site, swelling, bleeding, infection risk increase after surgery and potential for rejection of the ADM material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My gums do not have enough protective tissue around my teeth or implants.
Select...
My teeth next to the treatment area are healthy, or I have healthy implants or gums.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of soft tissue regenerated
Quantity of soft tissue regenerated (Width of Keratinized Tissue)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)Experimental Treatment1 Intervention
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.
Group II: Free gingival graft.Active Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had soft tissue grafting at the treatment site.My gums do not have enough protective tissue around my teeth or implants.I have active gum disease.I do not speak English.I am under 18 years old.I do not have any health conditions that would interfere with surgery or healing.My teeth next to the treatment area are healthy, or I have healthy implants or gums.My teeth or implants are missing protective gum tissue.
Research Study Groups:
This trial has the following groups:- Group 1: Strip Free gingival graft (SGG) + Acellular Dermal Matrix graft (ADM)
- Group 2: Free gingival graft.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Peri-implant Mucositis Patient Testimony for trial: Trial Name: NCT04920136 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research accommodating participants who are aged sixty and above?
"This trial allows all individuals aged 18 to 99 years old to participate, in accordance with the established inclusion criteria."
Answered by AI
Is this examination still accepting participants?
"Yes, according to clinicaltrials.gov the trial is actively recruiting patients and was first posted on September 17th 2021. The last update made to this study was October 20th 2022 and a total of 20 individuals are being sought from one site."
Answered by AI
May I partake in this research endeavor?
"This research initiative is recruiting 20 patients who have gingival atrophy, aged between 18 and 99. In addition to this requirement, they must be affiliated with UAB Dental School, possess periodontally healthy teeth or implants adjacent to the affected area(s), as well as meet the age of majority."
Answered by AI
What is the most extensive participant count for this clinical experiment?
"Affirmative. Clinicaltrials.gov documents that, after first being posted on September 17th 2021, this research project is currently enlisting 20 participants from just one medical facility."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Texas
Georgia
Other
How old are they?
18 - 65
What site did they apply to?
Unversity of Alabama at Birmingham, School of Dentistry
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
Why did patients apply to this trial?
I cannot afford implants. I’m tried if not being able to smile. Missing my smile. I had 3 kids by 21 and after my last baby my teeth crumble.
PatientReceived 1 prior treatment
My gums are receding they say I have gum disease and all my teeth are falling out.
PatientReceived 2+ prior treatments
Want the best outcome for mouth health and to get implants ,but I have to get the receding gum line taken care of first.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can you do a full set l? Does this entail the gum graft ans implants for mouth?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Unversity of Alabama at Birmingham, School of Dentistry: < 24 hours
Average response time
- < 1 Day
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