Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
NCT ID: NCT05717985
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
36 participants
INTERVENTIONAL
2023-02-22
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
de-epithelized gingival graft
Only dressing material will be placed at the donor site after graft harvesting
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* able to give informed consent;
* age ≥ 18 years;
* requiring palatal tissue harvesting for soft tissue augmentation in the oral cavity
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nik Madihah Nik Azis, DClinDent
Role: STUDY_DIRECTOR
Faculty of Dentistry, University Kebangsaan Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry
Kuala Lumpur, , Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GGPM-2022-024
Identifier Type: -
Identifier Source: org_study_id