The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment

NCT05270161 | Recruiting

• 1 other identifier: UFAlfenas
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to compare the tunnel technique/laterally closed tunnel technique and the FGG technique in the treatment of isolate/multiple GR in the anterior region of the mandible. Furthermore, it is proposed to evaluate the effect of a gel based on hyaluronic acid and green tea on the healing of the donor area after the removal of FGG from the palate. This work is expected to contribute to the still uncertain literature on the effectiveness of the tunnel technique as an alternative to the use of FGG in the treatment of multiple GR in the mandible.

Conditions

Gingival Recession

Keywords

Gingival Recession; Esthetics; Gingiva

Outcome Measures

Primary Outcomes (1)

• Recession depth

  Distance between cemento-enamel junction to free gingival margin.

  Change from baseline recession depth at 1, 3, 6 and 12 months

Secondary Outcomes (25)

• Recession width

  Change from baseline recession width at 1, 3, 6 and 12 months

• Probing depth

  Change from baseline probing depth at 1, 3, 6 and 12 months

• Clinical attachment level

  Change from baseline clinical attachment level at 1, 3, 6 and 12 months

• Keratinized tissue width

  Change from baseline keratinized tissue width at 1, 3, 6 and 12 months

• Gingival thickness

  Change from baseline gingival thickness at 6 and 12 months

Study Arms (6)

Test Group 1 (T1)

EXPERIMENTAL

Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique.

Procedure: Tunnel technique; Procedure: Gingival graft - donor area

Test Group 2 (T2)

EXPERIMENTAL

Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique.

Procedure: Laterally closed tunnel technique; Procedure: Gingival graft - donor area

Control Group 1 (C1)

ACTIVE COMPARATOR

Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.

Procedure: Free gingival graft; Procedure: Gingival graft - donor area

Control Group 2 (C2)

ACTIVE COMPARATOR

Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique.

Procedure: Free gingival graft; Procedure: Gingival graft - donor area

Gel Group (G)

EXPERIMENTAL

The donor area on the palate will be treated using hyaluronic acid gel and green tea applied by the participant 3 times a day for 7 days.

Procedure: Gingival graft - donor area

Clot Group (CO)

ACTIVE COMPARATOR

No material will be placed in the donor area, only the clot will be kept in position by means of sutures.

Procedure: Gingival graft - donor area

Interventions

Tunnel technique PROCEDURE

Intrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The incision was extended to the adjacent tooth on both sides of the multiple recessions. Dissection of the entire buccal aspect was performed as a partial-thickness flap using sharp tunnel elevators preserving the papillae. The flap was extended beyond the mucogingival junction and under each papilla allowing a tension-free flap mobilization in the coronal direction. The connective tissue graft was placed in the tunnel and was stabilized using absorbable suspensory sutures. The mobilized mucous flap was advanced coronally to the cemento enamel junction, and suspensory sutures were stitched.

Test Group 1 (T1)

Laterally closed tunnel technique PROCEDURE

Intrasulcular incisions on the buccal surface were made using a n°15 C blade, preserving the integrity of the papillae. The tunnel elevators were mobilized apically beyond the mucogingival line and extended medially and distally from the recession defect by undermining the facial surface of the interdental papillae. The insertion of muscles and fibers must be removed until a tension-free flap is obtained in the mesial, apical and distal directions. The preparation of the flap will be done carefully to avoid rupture of the papillae and perforation of the flap. As a result of this procedure, the mesial and distal margins of the flap must be brought together without tension to cover the exposed part of the root surface. The connective tissue graft was placed in the tunnel and was fixed mesially and distally at the inner aspect of the flap. Margins of the flap were pulled together over the graft and sutured with interrupted sutures.

Test Group 2 (T2)

Free gingival graft PROCEDURE

In the recipient area, a marginal horizontal linear incision will be made in the mucogingival junction with a n°15 C blade, creating a partial thickness flap, keeping the periosteum intact. The horizontal dimension of the receiving area will be determined according to the mesiodistal extension of the area without keratinized gingiva. All mobile soft tissues, including epithelium, connective tissue and muscle fibers will be removed from the donor area using scissors to ensure stability in the recipient area. The connective tissue graft will be obtained by the free gingival graft technique and will be sutured in the recipient area.

Control Group 1 (C1); Control Group 2 (C2)

Gingival graft - donor area PROCEDURE

The connective tissue graft will be obtained by the free gingival graft technique for all groups (T1, T2, T3 and T4). The mold of the prepared receiving area will be performed using sterile aluminum foil. The mold will be transferred to the donor area on the palate and the edges of the mold delimited with a scalpel blade. Deeper incisions will be made on the edges with the scalpel perpendicular to the palate, aiming to obtain a graft approximately 1.5 mm thick. With the scalpel blade parallel, the graft will be removed (epithelium and connective graft) maintaining its uniform thickness. For T1 and T2, the free gingival graft will be de-epithelialized. In donor area, a hyaluronic acid gel and green tea will be applied by the participant 3 times a day for 7 days (gel group) or no material will be placed in the donor area and the clot will be kept in position by means of sutures (clot group).

Clot Group (CO); Control Group 1 (C1); Control Group 2 (C2); Gel Group (G); Test Group 1 (T1); Test Group 2 (T2)

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 old;
• Present isolated (≥4mm) or multiple GR in the anterior region of the mandible (tooth 33 to 43) Miller Class I, II or III (87) (or Recession type (RT) 1 or RT2);
• Systemically healthy with no contraindications for periodontal surgery;
• Probing depth of less than 3mm at the sites involved;
• Selected teeth properly positioned, free from endodontic treatment, any type of restorative treatment, caries or non-carious cervical lesion

You may not qualify if:

• Participants who use tobacco or other types of drugs;
• Participants submitted to periodontal treatment in the last 6 months;
• Pregnant participants;
• Participants who did not accept to return to follow-ups;
• Participants who used antibiotics, corticosteroids, chemotherapy, immunomodulators or others that modify the periodontal therapy results during the last 6 months.

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead

Study Sites (1)

Universidade Federal de Alfenas

Alfenas, Minas Gerais, 37130-013, Brazil

RECRUITING

Related Publications (1)

• Oliveira JA, da Silveira MI, de Oliveira Alves R, Bezerra FJB, de Oliveira GJPL, Pigossi SC. Effect of a gel containing green tea extract and hyaluronic acid on palate pain scores and wound healing after free gingival graft: a quasi-randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6735-6746. doi: 10.1007/s00784-023-05282-x. Epub 2023 Sep 29.

  PMID: 37775584 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzane C Pigossi, PhD

  Alfenas Federal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzane C Pigossi, PhD

CONTACT

+55 19 981414158; suzane.pigossi@unifal-mg.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 8, 2022
• Study Start: November 5, 2021
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BR (1)