NCT05664373 The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Gingival Recessions
| NCT ID | NCT05664373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Belgrade |
| Condition | Gingival Recession Generalized Moderate |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2024-11-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-11-01 with a primary completion date of 2024-11-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Successful treatment of multiple gingival recessions (MRG) is a major challenge in periodontal plastic surgery due to complicated predisposing anatomical features of the surrounding tissues, such as a thin gingival phenotype or a limited zone of keratinized gingiva, variations in the depth and width of adjacent gingival recessions, shallow vestibulum and coronally inserted frenums and/or plica.The application of coronary advanced flap (CAF) or tunnel technique (TUN) with connective tissue graft (CTG) gives the best results in the therapy of MRG The application of connective tissue grafts in combination with various surgical techniques is accepted as the "gold standard" in GR therapy. A limitation in the application of CTG is the limited region of the donor site, especially in cases where a larger dimension of the CTG is required, or if the thickness of the hard palate tissue is inadequate. Techniques for obtaining subepithelial CTG (S-CTG), whether it is the trap-door technique or the single incision technique, are often associated with postoperative pain and discomfort, as well as necrosis/dehiscence of the palatal flap at the donor site. In order to overcome these limitations and obtain a firmer and more uniform CTG, especially when the thickness of the palatal tissue is inadequate (≤2.5 mm) and when a large dimension of the graft in the apico-coronary or mesio-distal direction is required, deepithelialization of the free gingival graft has been proposed (D-FGG). D-FGG has also been shown to be less prone to postoperative contraction, as it consists predominantly of collagen-rich connective tissue from the lamina propria, while adipose/glandular tissue is minimally represented. FGG can be deepithelialized intraorally with a diamond bur or diode laser, or extraorally with a scalpel. Despite all the biological advantages of D-FGG, there is scarce evidence in the literature about its histological characteristics after intraoral and extraoral deepithelialization, as well as the clinical outcomes of grafts thus obtained in combination with CAF in the treatment of MGR. Therefore, this aims of the study are to investigate the clinical efficacy and postoperative patient morbidity using D-FGG and modified CAF in the treatment of MGR, as well as to evaluate the histological characteristics of grafts obtained using two different deepithelialization techniques.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 60 years, * Non-smokers or consumption of up to 10 cigarettes per day, * no signs of gingival inflammation, * Presence of at least two single-rooted teeth with type I gingival recession ≥2 mm deep on the buccal side on both sides of the jaw, * Plaque index (PI) and gingival bleeding on provocation (BOP) \<15% and probing depth (PPD) \<3 mm, * Absence of non-carious cervical lesions (NCL) and undetectable cemento-enamel junctionr (CEJ) at defect sites, * No history of previous periodontal plastic surgery on the affected teeth. Exclusion Criteria: * Presence of carious lesions or restorations in the CEJ area, * Use of medications that affect periodontal health and healing, * Medical contraindications for periodontal surgical procedures, * Pregnancy and breastfeeding.
Contact & Investigator
Natasa Nikolic Jakoba, DDS, PhD
PRINCIPAL INVESTIGATOR
School of Dental Medicine, University of Belgrade, Serbia
Frequently Asked Questions
Who can join the NCT05664373 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Gingival Recession Generalized Moderate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05664373 currently recruiting?
Yes, NCT05664373 is actively recruiting participants. Contact the research team at natasa.nikolic.jakoba@stomf.bg.ac.rs for enrollment information.
Where is the NCT05664373 trial being conducted?
This trial is being conducted at Belgrade, Serbia.
Who is sponsoring the NCT05664373 clinical trial?
NCT05664373 is sponsored by University of Belgrade. The principal investigator is Natasa Nikolic Jakoba, DDS, PhD at School of Dental Medicine, University of Belgrade, Serbia. The trial plans to enroll 50 participants.