Comparing two techniques for harvesting gum tissue for oral surgery
A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
This study is testing two different methods for taking gum tissue during surgery to see which one helps patients heal better and feel less discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Locations | 1 site (Kuala Lumpur) |
| Trial ID | NCT05717985 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different techniques for harvesting palatal mucosal grafts used in gum surgery. Participants will be randomly assigned to receive either the modified combined approach for connective tissue grafts or the de-epithelized gingival graft technique. The study will assess post-operative recovery and outcomes using both examiner assessments and patient-reported outcomes. The goal is to determine which technique results in less morbidity and better healing, particularly in an Asian population.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18 and older who require palatal tissue harvesting for oral soft tissue augmentation.
Not a fit: Patients with periodontal diseases, poor oral hygiene, or those taking medications affecting periodontal tissues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing and reduced complications for patients undergoing gum tissue surgery.
How similar studies have performed: While the modified combined approach has potential, it has not been extensively investigated in previous studies, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * systemically healthy subjects; * able to give informed consent; * age ≥ 18 years; * requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity Exclusion Criteria: * subjects with periodontal diseases; * subjects with poor oral hygiene of \>30% plaque index; * pregnant or lactating females; * subjects taking medication with any known effect on the periodontal soft tissues; * subjects with pathology in the oral cavity causing any degree of pain; * subjects wearing removable or fixed prothesis that is in contact with the donor site an * those with allergies to painkillers including ibuprofen and paracetamol.
Where this trial is running
Kuala Lumpur
- Faculty of Dentistry — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Study coordinator: Nik Madihah Nik Azis, DClinDent
- Email: nikmadihah@ukm.edu.my
- Phone: 603-9289 7741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.