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

Gingival Recession Clinical Trial

Official title:

A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717985
• Other study ID #: GGPM-2022-024
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2023
• Source: National University of Malaysia
• Contact: Nik Madihah Nik Azis, DClinDent
• Phone: 603-9289 7741
• Email: nikmadihah[@]ukm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• modified 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.
• de-epithelized gingival graft
Only dressing material will be placed at the donor site after graft harvesting

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after gingival graft harvesting	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.	up to 3 months after surgery
Secondary	Healing after gingival graft harvesting	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).	up to 3 months after surgery