Actively Recruiting
A Randomized Controlled Trial Comparing De-epithelized Gingival Grafts and Modified Combined Approach for Connective Tissue Grafts
Led by National University of Malaysia · Updated on 2024-12-02
36
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of tissue grafting techniques used in oral soft tissue augmentation for patients undergoing palatal graft harvesting due to gingival recession. It focuses on assessing post-operative pain and healing outcomes between the modified combined approach and the de-epithelized gingival graft technique. The study is examiner-masked and randomized, involving systemically healthy adult participants, to better understand optimal graft harvesting methods in an Asian population. Participants are randomly assigned to one of two groups. The control group receives the de-epithelized gingival graft, where dressing material and sutures are placed at the donor site after graft harvesting. The test group undergoes the modified combined approach, which involves excising a thin layer of epithelium from the harvested graft and replacing this epithelial layer at the donor site before suturing. Both procedures are performed chairside during mucogingival surgery. During the study, researchers will collect data on pain levels and healing progress up to three months after surgery, using both examiner assessments and patient-reported outcomes. Participants will be monitored for post-operative morbidity and treatment results to determine which graft harvesting technique offers better outcomes. The total participation period includes follow-up evaluations up to three months post-surgery to ensure complete monitoring of healing and discomfort.
CONDITIONS
Brief Title
Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy subjects
- Able to give informed consent
- Age 18 years or older
- Require palatal tissue harvesting for soft tissue augmentation in the oral cavity
You will not qualify if you...
- Subjects with periodontal diseases
- Subjects with poor oral hygiene more than 30% plaque index
- Pregnant or lactating females
- Subjects taking medication affecting periodontal soft tissues
- Subjects with oral cavity pathology causing pain
- Subjects wearing removable or fixed prosthesis contacting the donor site
- Subjects with allergies to painkillers including ibuprofen and paracetamol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months after surgery
Participants undergo surgical harvesting of a palatal mucosal tissue graft using either the modified combined approach or de-epithelized gingival graft technique for oral soft tissue augmentation.
1 surgical visit and multiple follow-up visits during healing
Duration - Up to 3 months after surgery
Participants are monitored for post-operative morbidity including pain and healing after gingival graft harvesting.
Multiple visits over 3 months for assessment
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry
Kuala Lumpur, Malaysia, 50300
Actively Recruiting
Research Team
N
Nik Madihah Nik Azis, DClinDent
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here