Clinical trial NCT05717985: Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
Official title: A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Pain after gingival graft harvesting
timeFrame: up to 3 months after surgery
Secondary outcomes:
measure: Healing after gingival graft harvesting
timeFrame: up to 3 months after surgery
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry
Study officials:
affiliation: Faculty of Dentistry, University Kebangsaan Malaysia
name: Nik Madihah Nik Azis, DClinDent
role: STUDY_DIRECTOR
References: