Trials / Recruiting
RecruitingNCT05270161
The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment
Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Universidade Federal de Alfenas · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Free gingival graft (FGG) is a simple technique considered the most effective procedure to obtain gingival augmentation in sites with a minimal amount of keratinized gingiva. However, the abscence of chromatic integration and unsatisfactory texture of the graft after healing prevent its use in areas with high aesthetic demand. In this context, the tunnel technique (multiple gingival recessions \[GR\]) and the laterally closed tunnel technique (isolated GRs in the mandible) have been proposed as an alternative to the use of FGG in the treatment of GRs in the mandible. 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. Sixty participants presenting isolate/multiple Miller Class I, II, or III GR \[Recession type (RT) 1 or RT2\] in the anterior region of the mandible will be included in the present study. Regarding the treatment of GR, participants will be divided into four groups: (1) Test Group 1 (T1) (n=15): multiple GR in the anterior region of the mandible treated with the tunnel technique; (2) Test Group 2 (T2) (n=15): isolate GR in the anterior region of the mandible treated with the laterally closed tunnel technique; (3) Control Group 1 (C1) (n=15): multiple GRs in the anterior region of the mandible will be treated using the FGG technique and (4) Control Group 2 (C2) (n=15): isolate GRs in the anterior region of the mandible will be treated using the FGG technique. Regarding the treatment of the donor area, the same participants will be divided into two groups: (1) Gel Group (G) (n=30): 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; (2) Clot Group (CO) (n=30): No material will be placed in the donor area, only the clot will be kept in position by means of sutures. Periodontal clinical parameters will be evaluated in the receiving area at the beginning of the study and after 1, 3, 6 and 12 months postoperatively. In the donor area, the percentage of wound closure, the epithelialized surface area and the color of the palatine mucosa will be evaluated in both groups after 3, 7, 15 and 30 days. The visual analogue scale (VAS) of pain (donor and recipient area) and aesthetic (recipient area) will be used to assess the participant's perception of the treatment used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tunnel technique | 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. |
| PROCEDURE | Laterally closed tunnel technique | 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. |
| PROCEDURE | Free gingival graft | 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. |
| PROCEDURE | Gingival graft - donor area | 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). |
Timeline
- Start date
- 2021-11-05
- Primary completion
- 2025-11-05
- Completion
- 2025-11-05
- First posted
- 2022-03-08
- Last updated
- 2024-05-08
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05270161. Inclusion in this directory is not an endorsement.