Gingival Recession
Conditions
Brief summary
This study aims to compare the de-epithelized gingival graft (control group) and modified combined approach for connective tissue graft (test group) in patients undergoing palatal graft harvesting for mucogingival surgery in the oral cavity
Detailed description
Harvesting a palatal mucosal tissue graft as an autologous donor for oral soft tissue augmentation is widely practiced. Tissue harvest in patients with anatomically thin phenotypes can cause significant morbidity and compromised healing process. The modified combined approach (MCA) for connective tissue grafts has the potential for faster healing and fewer postoperative complications, compared to the recommended harvesting technique of de-epithelized gingival graft (DGG). However, the modified combined approach for connective tissue grafts have yet to be extensively investigated. This examiner-masked, randomized study aims to compare post-operative morbidity and treatment outcomes in patients undergoing modified combined approach for connective tissue graft (test group) compared to the de-epithelized gingival graft (control group) harvesting techniques in tissue augmentation. Participants will be randomized into two groups receiving one of either modified combined approach for connective tissue graft or de-epithelized gingival graft. Collection of the study parameters will utilize both examiner-assessed, and patient reported outcomes. The study will report on the optimum palatal mucosal graft harvesting technique in an Asian population. The findings of this study will be utilized to formulate clinical recommendations for soft tissues augmentation in this population.
Interventions
PROCEDUREmodified combined approach
A thin layer of epithelium will be excised from the harvested graft. This epithelium will be replaced at the donor site and sutured.
PROCEDUREde-epithelized gingival graft
Only dressing material will be placed at the donor site after graft harvesting
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain after gingival graft harvesting | up to 3 months after surgery | Measured using a self-reported questionnaire that is designed by the research group. The pain will be measured using a visual analogue score (minimum value=0 and maximum value=10), and using a surrogate measure of amount of painkillers taken by the participants after the surgery (minimum value= 0, maximum value= 2 grams for paracetamol, 1200 mg for ibuprofen). Higher score on the visual analogue scale and higher amount of painkillers taken is a worst outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing after gingival graft harvesting | up to 3 months after surgery | Measured clinically by the investigators. The donor site will be inspected and scored using the Wound Healing Index (Landry et. al, 1988). The photograph of the donor site will also be taken and analysed digitally to measure the amount of keratinisation using the ImageJ Software. Higher score on the Wound Healing Index is a better outcome (minimum score= 0, maximum score= 5). Higher amount of keratinised tissue as measured by the software is a better outcome (minimum value= 0, maximum value= the full surface of the donor site estimated at 3200 square mm). |
Countries
Malaysia
Contacts
Primary ContactNik Madihah Nik Azis, DClinDent
Outcome results
None listed