The Use of Coronary Displaced Flap and Deepithelialized Free Graft in the Treatment of Multiple Gingival Recessions

NCT05664373 | Recruiting

• 1 other identifier: EA 36/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession Generalized Moderate

Keywords

gingival recession; deepithelialized free gingival graft; coronally advanced flap; epithelial remnants

Outcome Measures

Primary Outcomes (1)

• the presence of the epithelial remnants in the D-FGG grafts

  The presence of the epithelial remnants in the D-FGG grafts, wich were deepithelialized in different manner, will be histologically assessed

  2 years

Secondary Outcomes (9)

• Periodontal probing depth (PPD)

  10 years

• postsurgery pain assessment

  2 months after surgery

• Root esthetic score (RES)

  10 years

• OHIP -14

  1 year

• Gingival recession depth

  10 years

Study Arms (2)

extraoraly de-epithelialized free gingival graft in combination with CAF

ACTIVE COMPARATOR

Epithelium will be removed after harvesting the graft by using the blade. By using the blade the epithelium will be separated from the connective tissue.

Procedure: Coronally advanced flap and deepithelized free gingival graft

intraoraly de-epithelialized free gingival graft in combination with CAF

EXPERIMENTAL

The epithelium will be removed prior to harvesting the graft from the palate. By using a diamond bur the epithelium will be removed until the connective tissue is exposed on the whole area of the intended graft size. Thereafter, the graft will be harvested.

Procedure: Coronally advanced flap and deepithelized free gingival graft

Interventions

Coronally advanced flap and deepithelized free gingival graft PROCEDURE

Free gingival grafts, de-epithelialized intraoraly or extraoraly in combination with coronally advanced flap will be used in the treatment of multiple gingival recessions.

extraoraly de-epithelialized free gingival graft in combination with CAF; intraoraly de-epithelialized free gingival graft in combination with CAF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Natasa Nikolic Jakoba

Belgrade, Serbia

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Natasa Nikolic Jakoba, DDS, PhD

  School of Dental Medicine, University of Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasa Nikolic Jakoba, DDS, PhD

CONTACT

+381638269909; natasa.nikolic.jakoba@stomf.bg.ac.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 23, 2022
• Study Start: November 1, 2022
• Primary Completion: November 10, 2024
• Study Completion (Estimated): December 10, 2034
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)