Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recession reduction
研究概览
简要总结
In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients were randomly assigned into intraorally de-epithelialization group (n=25) and extraorally de-epithelialization group (n=25) groups by one of the authors with an allocation ratio of 1:1 using a computer-generated program after successful completion of the phase I periodontal treatment. One calibrated author masked the applied surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.
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
- •Single tooth recession more than 2mm
- •Gingival thickness less than 1mm
排除标准
- •unstable endodontic conditions or presence of any restoration/abrasion,
- •tooth mobility, any surgical history or gingival enlargement in the area,
- •uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
研究组 & 干预措施
Intraoral
In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.
干预措施: Intraorally de-epithelialization (Procedure)
Extraoral
In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.
干预措施: Extraorally de-epithelialization (Procedure)
结局指标
主要结局
Recession reduction
时间窗: 12th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Recession reduction
时间窗: 3rd month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
Recession reduction
时间窗: 6th month
RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.
次要结局
- Recession width (RW)(12th month)
- percentage of deciduous cells(at the day of the surgery)
- Recession Depth (RD)(12th month)
- Keratinized Tissue Height (KTH)(12th month)
- amount of deciduous cells(at the day of the surgery.)
- Gingival Thickness (GT)(12th month)
- Probing pocket depth (PD)(12th month)
- Clinical attachment level (CAL)(12th month)
- Keratinized tissue change (KTC)(12th month)
- Wound healing index (WHI)(12th month)
- Aesthetics (A)(12th month)
- Tissue appearance (TA)(12th month)
- Dentine hypersensitivity (DH)(12th month)
- Vestibuler Depth(12th month)
- Recession Depth (RD)(Baseline.)
- Recession Depth (RD)(3rd month)
- Recession Depth (RD)(6th month)
- Keratinized Tissue Height (KTH)(baseline)
- Keratinized Tissue Height (KTH)(3rd month)
- Keratinized Tissue Height (KTH)(6th month)
- Gingival Thickness (GT)(baseline)
- Gingival Thickness (GT)(3rd month)
- Gingival Thickness (GT)(6th month)
- Recession width (RW)(baseline)
- Recession width (RW)(3rd month)
- Recession width (RW)(6th month)
- Probing pocket depth (PD)(baseline)
- Probing pocket depth (PD)(3rd month)
- Probing pocket depth (PD)(6th month)
- Clinical attachment level (CAL)(Baseline)
- Clinical attachment level (CAL)(3rd month)
- Clinical attachment level (CAL)(6th month)
- Keratinized tissue change (KTC)(3rd month)
- Keratinized tissue change (KTC)(6th month)
- Wound healing index (WHI)(3rd month)
- Wound healing index (WHI)(6th month)
- Tissue appearance (TA)(3rd month)
- Vestibuler Depth(baseline)
- Vestibuler Depth(3rd month)
- Tissue appearance (TA)(6th month)
- Dentine hypersensitivity (DH)(3rd month)
- Dentine hypersensitivity (DH)(6th month)
- Aesthetics (A)(3rd month)
- Aesthetics (A)(6th month)
- Vestibuler Depth(6th month)
研究者
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University