Effectiveness of Full-thickness Palatal Graft Technique (FTPGT) in Obtaining Complete Root Coverage

G. d'Annunzio University

Status: Completed

Conditions: Gingival Recession

Treatments: Procedure: CAF+SCTG treated patients; Procedure: FTPGT treated patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04028037

uchieti2

Details and patient eligibility

About

In this randomized controlled clinical trial we will compare the clinical outcome of Full thickness palatal graft technique (FTPGT) to coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) in the treatment of RT1 (Cairo et al. classification) recessions.

Forty patients, presenting at least one RT1 recession, will be treated with bilaminar procedures . 20 participants will receive FTPGT approach (test group) and 20 patients will undergo CAF+SCTG (control group). Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment. Patient-reported outcome measures (PROMs) will be reported: namely, the number of painkiller tablets taken during the first week, the degree of general discomfort (D) experienced assessed on a VAS scale (0-10), the extent of changes in their eating habits (CFH), dentin hypersensitivity (DH), patient-reported aesthetic satisfaction (PRES) quantified on a VAS scale (0-10) and overall treatment satisfaction (OTS).

Full description

This study will be a prospective, randomized and controlled clinical trial designed to compare two modalities of treatment of RT1 recessions: FTPG versus CAF+SCTG. From each patient study one RT1 recession will be included. Clinical parameters will be evaluated at baseline and 12 months after treatment.

40 patients seeking treatment at the Unit of Periodontology of the University of Chieti, Pescara, Italy, and affected by RT1 recessions will be selected for the study.

All 40 patient will undergo a professional supra-gingival scaling by ultrasonic instruments. To each patient motivational oral home care instructions in order to acquire correct and pressure-less brushing technique and a-traumatic use of dental floss and/or inter-dental brush will be given. In addition electric toothbrush use with controlled pressure with extra-soft head will be suggested and instructions about it will be conferred. Only the achievement of supra-gingival plaque control through a-traumatic oral hygiene procedures will permit the access of the surgical step.

Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.

The post-surgical care will be founded for all patients on 2 g/day amoxicillin plus clavulanic acid for 6 days, oral ketoprofen for pain-control if needed . Two weeks after surgery suture will be removed. Plaque control of grafted area will be performed for 3 weeks after surgery through a double rinse in a day with 0.12% chlorhexidine digluconate solution. Furthermore, the patients will use a 1% chlorhexidine gel twice daily. Patients underwent weekly supragingival hygiene and motivational reinforcement for 6 weeks. Cautious brushing by a soft toothbrush and interdental brushing will be recommended only 2 weeks after sutures removal.

All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 12 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT) will be assessed at baseline and 12 months after treatment.

PROMs will also be evaluated. That is, patients will be asked to write down the number of painkiller tablets (400 mg of ibuprofen) taken during the study the first week.

The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10), and the extent of changes in their eating habits (CFH) caused by the palate will be indicated wound. Dentin hypersensitivity (DH) will be evaluated at T0 and T1 according to a scale from 0 to 3 (0" reaction to the air stimulus; "1" reaction without requiring its termination; "2" reaction and request to stop it; "3" painful stimulus complaint).

Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
• never smokers/former smokers >=10years
• a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
• no periodontal surgery on the experimental sites
• >= 20 teeth without mobility
• no presence of cervical carious lesions or periapical lesions at experimental sites
• at leat one RT1 buccal gingival recession

Exclusion criteria

• systemic diseases
• coagulation disorders
• medications affecting periodontal status in the previous 6 months
• pregnancy or lactation
• Smokers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

FTPGT treated patients

Experimental group

Description:

The recipient site will be prepared according to Langer\&Langer modified technique, raising a split-thickness flap without vertical incisions. The harvest of palatal graft will be done using FTPG technique ant it will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central "U" shaped part.The palatal graft will be adapted to the recipient site and sutured.

Treatment:

Procedure: FTPGT treated patients

CAF+SCTG treated patients

Active Comparator group

Description:

A tension-free trapezoidal flap will be elevated by the split-full-split technique. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap by 5-0 silk sutures.

Treatment:

Procedure: CAF+SCTG treated patients