Comparative Evaluation of the Tunnel Technique and Free Gingival Graft in Gingival Recessions Treatment: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recession depth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Recession depth
时间窗: Change from baseline recession depth at 1, 3, 6 and 12 months
Distance between cemento-enamel junction to free gingival margin.
次要结局
- Recession width(Change from baseline recession width at 1, 3, 6 and 12 months)
- Gingival margin position(Change from baseline gingival margin position at 1, 3, 6 and 12 months)
- Graft thickness after removal(Baseline)
- Width of keratinized tissue in graft(Change from immediate postoperative width of keratinized tissue in graft at 1, 3, 6 and 12 months)
- Percentage of wound reduction by photographic image(Change from 3 days percentage of wound reduction by photographic image at 7, 15 and 30 days)
- Percentage of Wound Reduction by clinical measurement(Change from 3 days percentage of wound reduction by clinical measurement at 7, 15 and 30 days)
- Palatal mucosa color(Change from 3 days palatal mucosa color at 7, 15 and 30 days)
- 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)
- Postoperative complications(7 days)
- Graft thickness immediately before suture(Baseline)
- Graft contraction(Change from immediate postoperative graft contraction at 1, 3, 6 and 12 months)
- Landry index(Change from 3 days landry index at 7 and 30 days)
- Visual Analogue Scale (VAS) for pain(Change from 3 days VAS scale for pain at 7, 12 and 30 days)
- Presence or absence of dentin sensitivity(Change from 1 month dentin sensitivity at 3, 6 and 12 months)
- Height of keratinized tissue in graft(Change from immediate postoperative height of keratinized tissue in graft at 1, 3, 6 and 12 months)
- Epithelized surface area(Change from 3 days epithelized surface area at 7, 15 and 30 days)
- Root coverage esthetic score (RES)(12 months)
- Visual Analogue Scale (VAS) for esthetics(12 months)
- Analgesics consumption(7 days)