Clinical trial NCT05270161: The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment
Official title: Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival Recession
Esthetics
Gingiva
Lead sponsor: Universidade Federal de Alfenas
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recession depth
timeFrame: Change from baseline recession depth at 1, 3, 6 and 12 months
Secondary outcomes:
measure: Recession width
timeFrame: Change from baseline recession width at 1, 3, 6 and 12 months
measure: Probing depth
timeFrame: Change from baseline probing depth at 1, 3, 6 and 12 months
measure: Clinical attachment level
timeFrame: Change from baseline clinical attachment level at 1, 3, 6 and 12 months
measure: Keratinized tissue width
timeFrame: Change from baseline keratinized tissue width at 1, 3, 6 and 12 months
measure: Gingival thickness
timeFrame: Change from baseline gingival thickness at 6 and 12 months
measure: Gingival margin position
timeFrame: Change from baseline gingival margin position at 1, 3, 6 and 12 months
measure: Graft thickness after removal
timeFrame: Baseline
measure: Graft thickness immediately before suture
timeFrame: Baseline
measure: Height of keratinized tissue in graft
timeFrame: Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months
measure: Width of keratinized tissue in graft
timeFrame: Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months
measure: Graft contraction
timeFrame: Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months
measure: Percentage of wound reduction by photographic image
timeFrame: Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days
measure: Percentage of Wound Reduction by clinical measurement
timeFrame: Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days
measure: Epithelized surface area
timeFrame: Change from 3 days epithelized surface area at 7, 15 and 30 days
measure: Palatal mucosa color
timeFrame: Change from 3 days palatal mucosa color at 7, 15 and 30 days
measure: Postoperative complications
timeFrame: 3 days
measure: Postoperative complications
timeFrame: 7 days
measure: Landry index
timeFrame: Change from 3 days landry index at 7 and 30 days
measure: Root coverage esthetic score (RES)
timeFrame: 6 months
measure: Root coverage esthetic score (RES)
timeFrame: 12 months
measure: Visual Analogue Scale (VAS) for pain
timeFrame: Change from 3 days VAS scale for pain at 7, 12 and 30 days
measure: Presence or absence of dentin sensitivity
timeFrame: Change from 1 month dentin sensitivity at 3, 6 and 12 months
measure: Visual Analogue Scale (VAS) for esthetics
timeFrame: 6 months
measure: Visual Analogue Scale (VAS) for esthetics
timeFrame: 12 months
measure: Analgesics consumption
timeFrame: 7 days
Other outcomes:
Locations:
city: Alfenas
country: Brazil
facility: Universidade Federal de Alfenas
state: Minas Gerais
Study officials:
affiliation: Alfenas Federal University
name: Suzane C Pigossi, PhD
role: PRINCIPAL_INVESTIGATOR
References: