Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gingival Thickness (GT)
研究概览
简要总结
In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients were randomly assigned into modified coronally advanced tunnel (n=25) and epithelialized free gingival graft (n=25) groups by one of the authors with an allocation ratio of 1:1 by using a computer-generated program after successful completion of phase I periodontal treatment. One calibrated author masked to the applied surgical technique recorded all clinical variables. The labeled envelope containing the intervention name was opened by the surgeon.
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
- •presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
- •presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
- •aged between 18-60.
排除标准
- •unstable endodontic conditions or presence of any restoration/abrasion,
- •tooth mobility, any surgical history or gingival enlargement in the area,
- •smoking or alcohol use,
- •uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
研究组 & 干预措施
modified coronally advanced tunnel technique
Initial sulcular incisions and flap separation were then carried out with tunnel knives. Dissection was extended at least 8 mm apically to the mucogingival junction and the muscle attachments were removed with curettes so that the flap could be moved in a coronal direction without tension. Interdental papillae were undermined to prepare the bed for connective tissue graft placement. Connective tissue graft was then inserted under the tunnel at the sites of recession and retracted laterally by sutures towards each end of the tunnel. After connective tissue graft positioning, the flap was gently stretched coronally to obtain passive flap closure. The exposed connective tissue was covered by connecting the adjacent flap margins with additional sutures.
干预措施: Modified coronally advanced tunnel technique (Procedure)
epithelialized free gingival graft
A partial-thickness flap was elevated (blade #15c) with horizontal incisions at the cemento-enamel junction level of the adjacent teeth. Then, two vertical incisions extending to the apical were made from two ends of the horizontal incision. The epithelium in the framed region was removed with a scalpel and the underlying connective tissue was exposed. To achieve the best vascularization from the recipient site, bed preparation was completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region.
干预措施: Epithelialized free gingival graft (Procedure)
结局指标
主要结局
Gingival Thickness (GT)
时间窗: 12th month
GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Gingival Thickness
时间窗: Baseline
GT, measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).
Keratinized Tissue Height (KTH)
时间窗: 12th month.
KTH, measured from gingival margin to the mucogingival junction (MGJ).
次要结局
- Probing pocket depth (PD)(12th month.)
- Keratinized tissue change (KTC)(12th month)
- Wound healing index (WHI)(6th week)
- Aesthetics (A)(6th week)
- Recession Depth (RD)(12th month.)
- Recession width (RW)(12th month.)
- Clinical attachment level (CAL)(12th month)
- Patient expectations (PE)(6th week)
- Tissue appearance (TA)(6th week)
- Dentine hypersensitivity (DH)(6th week)
研究者
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University