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

NCT04028037 | Completed DMC

• 1 other identifier: uchieti2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of Complete Root Coverage (CRC)

  Percentage of teeth with CRC determined with the following formula: T0 GR-T1 GR/T0 GR.

  12 months

Secondary Outcomes (10)

• Clinical Attachment Level (CAL)

  12 months

• Pocket Depth (PD)

  12 months

• Gingival Thickness (GT)

  12 months

• Keratinized Tissue width (KT)

  12 months

• Number of painkiller tables

  First week after surgery

Study Arms (2)

FTPGT treated patients

EXPERIMENTAL

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.

Procedure: FTPGT treated patients

CAF+SCTG treated patients

ACTIVE COMPARATOR

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.

Procedure: CAF+SCTG treated patients

Interventions

FTPGT treated patients PROCEDURE

The recipient bed will be prepared according to Langer\&Langer modified technique. Intrasulcular incision will be performed from at least one tooth mesial and one tooth distal to the tooth with gingival recession, without vertical incisions.A split-thickness flap will be raised.The harvest of palatal graft will be done using FTPG technique. An incision, parallel to the gingival margin, deep to the bone, will be made. At the center of this incision, a "U" shaped one about 1-2mm deep will made, with the convex side towards the palatine vault.The width of the "U" incision will be equal to the width of the GR and the length will be 1mm greater.A split-thickness dissection of the area surrounding the "U" shaped incision will be done.The graft will be removed by detaching it from the bony surface.The graft will be made up of an apico-lateral portion of connective tissue and periosteum, and of a full-thickness central part.The palatal graft will be adapted to the recipient site and sutured.

FTPGT treated patients

CAF+SCTG treated patients PROCEDURE

According to De Sanctis \& Zucchelli, a tension-free trapezoidal flap will be elevated by the split-full-split technique and the anatomic papillae will be de-epithelialized. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. The height of the graft was equal to the distance between the buccal bone crest and the CEJ. 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, sutured about 2mm over the CEJ by 5-0 silk sutures.

CAF+SCTG treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

Related Publications (1)

• Paolantonio M, De Ninis P, Santamaria P, Balice G, Serroni M, Sinjari B, Frisone A, Di Gregorio S, Romano L, Murmura G, Femminella B. Clinical comparison of two surgical techniques in obtaining complete root coverage of single RT1 gingival recessions. Clin Oral Investig. 2025 Sep 10;29(10):444. doi: 10.1007/s00784-025-06491-2.

  PMID: 40928531 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• michele paolantonio

  università G. D'annunzio Chieti-Pescara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Custom made computer-generated table provides the randomly allocation of experimental unit in the two groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Periodontology

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 22, 2019
• Study Start: November 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)