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

Primary Purpose

Gingival Recession

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
modified combined approach
de-epithelized gingival graft
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

de-epithelized gingival graft

modified combined approach

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 17, 2023
Last Updated
March 22, 2023
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05717985
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
de-epithelized gingival graft
Arm Type
Active Comparator
Arm 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.
Arm Title
modified combined approach
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
modified combined approach
Intervention Description
A thin layer of epithelium will be excised from the harvested graft. This epithelium will be replaced at the donor site and sutured.
Intervention Type
Procedure
Intervention Name(s)
de-epithelized gingival graft
Intervention Description
Only dressing material will be placed at the donor site after graft harvesting
Primary Outcome Measure Information:
Title
Pain after gingival graft harvesting
Description
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.
Time Frame
up to 3 months after surgery
Secondary Outcome Measure Information:
Title
Healing after gingival graft harvesting
Description
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).
Time Frame
up to 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nik Madihah Nik Azis, DClinDent
Phone
603-9289 7741
Email
nikmadihah@ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nik Madihah Nik Azis, DClinDent
Organizational Affiliation
Faculty of Dentistry, University Kebangsaan Malaysia
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nik Madihah Nik Azis, DClinDent
Phone
603-9289 7741
Email
nikmadihah@ukm.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No

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

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