The Comparison of Different Root Coverage Techniques Using the Anatomical Recession Area Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anatomical Recession Rate (ARR)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of two treatments for gingival recession. The main questions it aims to answer are:
Which treatment method, Coronally Positioned Flap with Connective Tissue Graft or Modified Coronally Advanced Tunnel with connective tissue graft, is more effective in treating gum recession? How does the Anatomical Recession Rate, a new measurement technique, help in evaluating the success of these treatments?
The patients will be treated with coronally advanced flap or modified coronally advanced tunnel + connective tissue graft to see which method is more effective in reducing gum recession, as measured by using anatomical recession rate.
详细描述
The aim of this study is to evaluate the success of gingival recession treatment methods of coronally advanced flap (CAF) and modified coronally advanced tunnel (MCAT) by using the anatomical ratio rate (ARR). In the parallel-group two-arm randomized clinical study, 40 randomly assigned participants into CAF and MCAT groups will be enrolled. The assessor and investigator will be masked to the interventions that will be applied.
Intervention (CAF): After local anesthesia, the recipient area will be prepared by making a vertical incision from the mesial and/or distal of the last tooth areas where the recession ends, and by applying split-full-split-thickness incisions along with sulcular and subpapillary incisions, thus releasing the flap to facilitate coronal movement. Afterwards, the anatomical papillae will be deepithelised and the recipient area preparation will be completed by applying SRP to the root surfaces. Then, CTG will be harvested from the palatal region by measuring the dimensions of the recession defect. The obtained CTG will be placed on the root surface and sutured to the anatomical papillae with the resorbable sutures. Then, the flap will be sutured to the anatomical papillae with suspended sutures, completely covering the connective tissue graft. Finally, vertical incisions will be sutured to easily coronally position the flap Intervention (MCAT): A split-thickness envelope flap will be created by performing supraperiosteal undermining with tunnel blades and elevators along the facial surface of the papilla. Undermining will be extended to the apical part of the mucogingival line. In order to coronally position the flap, the papillary region will be elevated in full thickness and a supraperiosteal envelope recipient bed will be created. Then, CTG will be obtained according to the size of the recession defect from the palatal region and placed under the tunnel with guide sutures and positioned on the root surfaces, and then the envelope flap will be sutured by pulling it coronally with double cross sutures to completely cover the CTG.
Primary Outcome Measure:
Anatomical Recession Rate (ARR): The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage [Time Frame: 12 months post-treatment].
Secondary Outcome Measures:
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 (Investigator, Outcomes Assessor)
盲法说明
This study implements single-blind masking where outcomes assessors are unaware of participants' group assignments to minimize bias. While blinding participants and care providers is not feasible due to the nature of surgical interventions, strict protocols ensure assessors remain blinded to treatment allocation throughout the study, enhancing outcome evaluation objectivity.
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
- •Participants aged 18 to 60 years.
- •Individuals with the gingival recession of Miller Class I, II, or III in at least one tooth in the anterior mandibular or maxillary region.
- •Participants must have at least 1 mm of keratinized tissue width around the affected tooth/tooth and be in good general health.
- •Ability to provide informed consent for participation in the study.
排除标准
- •Individuals with uncontrolled systemic diseases that could impact periodontal healing (e.g., diabetes mellitus, cardiovascular diseases).
- •Current smokers or those who have quit smoking less than 6 months before the study.
- •Women who are pregnant or breastfeeding.
- •Participants who have received periodontal or gingival recession treatment in the study area within the last year.
- •Presence of acute periodontal or dental infections requiring immediate treatment, or extensive caries affecting the study teeth.
研究组 & 干预措施
Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG)
Participants in this arm will receive a Coronally Positioned Flap (CPF) surgery combined with a Connective Tissue Graft (CTG). The CPF technique involves surgically repositioning the gum tissue to cover exposed root surfaces, while the CTG procedure involves transplanting connective tissue to the area of gingival recession to encourage regeneration and coverage of exposed roots. This arm aims to evaluate the effectiveness of CPF with CTG in improving gingival recession and periodontal health.
干预措施: Coronally Positioned Flap with Connective Tissue Graft (Procedure)
Modified Coronally Advanced Tunnel (MCAT) with Connective Tissue Graft (CTG)
This arm involves participants receiving the Modified Coronally Advanced Tunnel (MCAT) procedure along with a Connective Tissue Graft (CTG). The MCAT technique is a less invasive approach that creates a tunnel under the gum through which the connective tissue graft is placed without making significant incisions. This method aims to treat gingival recession by encouraging gum regeneration over the exposed roots, with the goal of improving periodontal outcomes and reducing recession.
干预措施: Modified Coronally Advanced Tunnel with Connective Tissue Graft (Procedure)
结局指标
主要结局
Anatomical Recession Rate (ARR)
时间窗: 12 months post-treatment
The primary outcome measure is the Anatomical Recession Rate (ARR), which quantifies the effectiveness of the Coronally Positioned Flap (CPF) with Connective Tissue Graft (CTG) and the Modified Coronally Advanced Tunnel (MCAT) with CTG in covering exposed root surfaces. ARR is calculated by measuring the linear distance between the gingival margin and the cementoenamel junction before and after treatment, with improvements in ARR indicating successful root coverage.
次要结局
- Wound healing index (WHI)(2 weeks post-treatment)
- Clinical Attachment Level (CAL)(Baseline, 3, 6, and 12 months post-treatment)
- Aesthetic evaluation(6 and 12 months post-treatment)
- Tissue appearance(6 and 12 months post-treatment)
- Gingival Thickness (GT)(Baseline and 12 months post-treatment)
- Keratinized Tissue Thickness (KTT)(Baseline, 3, 6, and 12 months post-treatment)
- Dentin hypersensitivity(Baseline, 6, and 12 months post-treatment)
研究者
Gencay Keceli
Assoc. Prof. Dr.
Hacettepe University