The Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment
- Conditions
- Gingival Recession
- Interventions
- Procedure: Free gingival graftProcedure: Tunnel techniqueProcedure: Laterally closed tunnel techniqueProcedure: Gingival graft - donor area
- Registration Number
- NCT05270161
- Lead Sponsor
- Universidade Federal de Alfenas
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group 2 (C2) Free gingival graft Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Test Group 1 (T1) Tunnel technique Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique. Test Group 2 (T2) Laterally closed tunnel technique Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique. Control Group 1 (C1) Free gingival graft Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Test Group 1 (T1) Gingival graft - donor area Multiple gingival recessions in the anterior region of the mandible treated with the tunnel technique. Test Group 2 (T2) Gingival graft - donor area Isolate gingival recessions in the anterior region of the mandible treated with the laterally closed tunnel technique. Control Group 1 (C1) Gingival graft - donor area Multiple gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Control Group 2 (C2) Gingival graft - donor area Isolate gingival recessions in the anterior region of the mandible will be treated using the free gingival graft technique. Gel Group (G) Gingival graft - donor area 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. Clot Group (CO) Gingival graft - donor area No material will be placed in the donor area, only the clot will be kept in position by means of sutures.
- Primary Outcome Measures
Name Time Method Recession depth Change from baseline recession depth at 1, 3, 6 and 12 months Distance between cemento-enamel junction to free gingival margin.
- Secondary Outcome Measures
Name Time Method Recession width Change from baseline recession width at 1, 3, 6 and 12 months Mesio-distal extent of gingival recession
Gingival margin position Change from baseline gingival margin position at 1, 3, 6 and 12 months Distance from a reference point performed on the customized stent to the gingival margin.
Graft thickness after removal Baseline Graft thickness will be assessed immediately after removal using a endodontic file in the middle of the graft. The distance between the marker and the tip of the file will be determined using a digital caliper.
Width of keratinized tissue in graft Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months Mesio-distal dimension of the graft in the most coronal portion of the graft using the periodontal probe.
Percentage of wound reduction by photographic image Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days The millimeter periodontal probe will be positioned next to the wound at the time of obtaining the photos to calibrate the image analysis software that will be used to calculate the total area of the wound in donor region.
Percentage of Wound Reduction by clinical measurement Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days The height and width of the wound will be determined using the periodontal probe.
Palatal mucosa color Change from 3 days palatal mucosa color at 7, 15 and 30 days The color of the palatal mucosa will be evaluated by the visual analogue scale (VAS) in comparison with the color of the adjacent and opposite mucosa. In this evaluation, on a horizontal scale, 0 points will represent lack of color correspondence, 50 points will represent average correspondence and 100 points will represent excellent color correspondence with the adjacent tissues.
Probing depth Change from baseline probing depth at 1, 3, 6 and 12 months Distance between free gingival margin to the bottom of the sulcus.
Clinical attachment level Change from baseline clinical attachment level at 1, 3, 6 and 12 months Distance between cemento-enamel junction to the bottom of the sulcus.
Keratinized tissue width Change from baseline keratinized tissue width at 1, 3, 6 and 12 months Distance between the most apical point on free gingival margin to the mucogingival junction.
Gingival thickness Change from baseline gingival thickness at 6 and 12 months The measurements were registered at the mid-buccal aspect of the tooth using a endodontic file. The distance between the marker and the tip of the file will be determined using a digital caliper.
Postoperative complications 7 days Presence of bleeding, swelling, infection and necrosis in the donor area will be recorded
Graft thickness immediately before suture Baseline The thickness of the graft immediately before suturing will be evaluated after de-epithelialization (in the T group) and the removal of adipose tissue when present in both groups in the middle of the graft. The distance between the marker and the tip of the file will be determined using a digital caliper.
Graft contraction Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months Graft areas will be calculated by multiplying the height and width of keratinized tissue in graft.
Landry index Change from 3 days landry index at 7 and 30 days Classify the degree of repair based on erythema, presence of granulation tissue, bleeding/suppuration, and epithelialization in the recipient area. A score of 1 to 5 is given, where 1 is associated with a very poor/inadequate repair process and 5 is excellent.
Visual Analogue Scale (VAS) for pain Change from 3 days VAS scale for pain at 7, 12 and 30 days The perception of pain will be recorded using the VAS scale at the operated sites. Participants will record the level of pain in the recipient and donor areas after the procedure on a horizontal scale, where the left endpoint will mean no pain (0), the midpoint of mean pain (50 ) and the right outcome severe pain (100).
Presence or absence of dentin sensitivity Change from 1 month dentin sensitivity at 3, 6 and 12 months Determined from the participants' responses regarding the presence or absence of sensitivity in the cervical sites. For this, it will be asked if the participant has or not dentin sensitivity after a cold or air stimulus.
Height of keratinized tissue in graft Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months Apico-coronal dimension of the graft measured at the stent mark using the periodontal probe.
Epithelized surface area Change from 3 days epithelized surface area at 7, 15 and 30 days The epithelialization analysis will be performed using 3% oxygen peroxide to observe the presence of blistering in the wound. The absence of epithelialization will be characterized as blistering after contact of oxygen peroxide with the wound. This parameter will be noted dichotomously (presence/absence of bubbles), being noted as yes or no, respectively, in the participant's form.
Root coverage esthetic score (RES) 12 months The RES system evaluates five variables of the recipient area including: gingival margin level, marginal tissue contour, soft tissue texture, JMG alignment and gingival color. Zero, 3 or 6 points will be used to assess the position of the gingival margin, while a score of 0 or 1 point will be used for each of the other variables. The ideal aesthetic score will be 10.
Visual Analogue Scale (VAS) for esthetics 12 months Participants will be asked to express their overall satisfaction with treatment outcomes on a VAS scale, where the left endpoint will mean not at all satisfied (0), the midpoint reasonably satisfied (50) and the right endpoint extremely satisfied. satisfied (100).
Analgesics consumption 7 days The consumption of analgesics by the participants in the first 7 postoperative days will also be recorded.
Trial Locations
- Locations (1)
Universidade Federal de Alfenas
🇧🇷Alfenas, Minas Gerais, Brazil