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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Belgrade

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coronally advanced flap and deepithelized free gingival graft

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: extraoraly de-epithelialized free gingival graft in combination with CAFActive comparator 1 intervention
Group B: intraoraly de-epithelialized free gingival graft in combination with CAFExperimental treatment 1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

1

Periodontal probing depth (PPD)

The distance from the gingival margin to the apical portion of the gingival sulcus using the periodontal probe.

Time frame
10 years
2

postsurgery pain assessment

VAS will be used to assess postoperative patient morbidity parameters (postoperative pain, patient discomfort, tenderness, and bleeding) in relation to deepithelialization technique and graft size

Time frame
2 months after surgery
3

Root esthetic score (RES)

assessment of esthetic parameters of the treated region after surgery

Time frame
10 years
4

OHIP -14

examination of the impact of surgical therapy of multiple recessions on the quality of life of patients

Time frame
1 year

Other outcomes

Sponsors and contacts

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