Evaluation of De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: modified combined approach, de-epithelized gingival graft.
- Who it may be relevant to
- Registry conditions: Gingival Recession. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial to Compare De-epithelized Connective Tissue Grafts and Modified Combined Approach for Connective Tissue Grafts
Overview
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.
Interventions
- 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. - Procedure de-epithelized gingival graft
Only dressing material will be placed at the donor site after graft harvesting
Primary outcome measures
- Pain after gingival graft harvesting [Time frame: up to 3 months after surgery]
Secondary outcome measures (1)
- Healing after gingival graft harvesting [Time frame: up to 3 months after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- Faculty of Dentistry — Kuala Lumpur
Identifiers
NCT: NCT05717985 · GGPM-2022-024