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Collagen Matrix After Gum Grafting for Gum Recession
N/A
Recruiting
Led By Ying S Wang, DDS, MS
Research Sponsored by Hailey Bivens
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, 4 months, 6 months
Awards & highlights
Study Summary
This trial is comparing if there are changes in tissue thickness and volume between sites with or without augmentation following a gum graft harvesting.
Who is the study for?
This trial is for people aged 18-65 who have healthy gums but need a gum graft, are non-smokers, and haven't had palate surgery or orthodontic treatments involving palatal expansion. They must be in good physical and mental health without any conditions that would complicate periodontal surgery.Check my eligibility
What is being tested?
The study tests if adding a collagen matrix to the donor site in the palate after a gum graft leads to changes in tissue thickness and volume. Participants will either receive this augmentation or not, randomly assigned, to compare outcomes between the two groups.See study design
What are the potential side effects?
Potential side effects may include discomfort at the donor site on the palate, swelling, bruising, bleeding or infection. The use of collagen matrix could also cause allergic reactions for those sensitive to its components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months, 4 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, 4 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Palatal Thickness Change
Palatal Volume Change
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Collagen MatrixExperimental Treatment1 Intervention
Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.
Group II: ControlActive Control1 Intervention
Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.
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Who is running the clinical trial?
Hailey BivensLead Sponsor
Ying S Wang, DDS, MSPrincipal InvestigatorTexas A&M School of Dentistry
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active gum disease.I haven't used tobacco or nicotine products in the last 5 years.My gums are healthy.I can attend all required study appointments.I have diabetes with blood sugar over 110mg/l and HbA1c over 6.5%.I haven't taken any medications that affect gum health in the last 6 months.I am healthy enough for gum surgery, both physically and mentally.I have had treatments like bisphosphonate therapy, radiotherapy in the head/neck, or chemotherapy for cancer.I do not have conditions like bleeding disorders or HIV that affect healing.I have had surgery on the roof of my mouth.My body does not have the right tissue for a donor site.I am between 18 and 65 years old.My gender does not affect my eligibility.I am not allergic to the medications or materials used in this study.I am not taking medications that affect healing or my gums.I need surgery for my gums that involves taking tissue from the roof of my mouth.I have never had surgery on my palate.I have never had orthodontic treatment to widen my palate.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Collagen Matrix
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly patients eligible to participate in this trial?
"Those who are of legal age or older and below 65 years old may be eligible to participate in this trial."
Answered by AI
Am I eligible to join this research program?
"To be considered for this trial, potential participants must have an occurrence of gingival recession and fit within the recommended age range (18-65). Up to 40 people will be admitted."
Answered by AI
Is the recruitment process for this research still ongoing?
"According to the clinicaltrials.gov, this protocol is not presently recruiting patients; however, it was originally posted on August 1st of 2023 and last updated on July 16th of the same year. Presently, there are 43 additional medical trials actively seeking participants."
Answered by AI
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