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

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

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

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: de-epithelized gingival graft; Procedure: modified combined approach

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nik Madihah Nik Azis, DClinDent; Phone Number: 603-9289 7741; Email: nikmadihah@ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Recruiting
    • Faculty of dentistry
    • Contact: Nik Madihah Nik Azis, DClinDent; Phone Number: 603-9289 7741; Email: nikmadihah@ukm.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: de-epithelized gingival graft; 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.	Procedure: de-epithelized gingival graft; Only dressing material will be placed at the donor site after graft harvesting
Experimental: modified combined approach; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Study Director: Nik Madihah Nik Azis, DClinDent, Faculty of Dentistry, University Kebangsaan Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: GGPM-2022-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No