Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

National University of Malaysia

Status: Enrolling

Conditions: Gingival Recession

Treatments: Procedure: de-epithelized gingival graft; Procedure: modified combined approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05717985

GGPM-2022-024

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

de-epithelized gingival graft

Active Comparator group

Description:

A type of mucogingival surgery where a gingival graft is harvested from the palate, prepared chairside and placed on a recipient site to augment it. Dressing material and sutures is placed at the donor site.

Treatment:

Procedure: de-epithelized gingival graft

modified combined approach

Experimental group

Description:

A type of mucogingival surgery where a gingival graft is harvested from the palate, prepared chairside and placed on a recipient site to augment it. A part of the prepared tissues namely the epithelial layer is replaced at the donor site and sutured.

Treatment:

Procedure: modified combined approach