Evaluation of the Modified Coronally Advanced Tunnel Technique Associated With a Selective/Segmented Versus Contiguous Submerged Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Digital complete root coverage
研究概览
简要总结
The goal of this study is to evaluate how effective a gum grafting procedure is in treating gum recession that affects several teeth. Gum recession happens when the gum tissue pulls away from the tooth, exposing the roots. The study will look at how the treatment improves gum health, appearance, and function.
A total of 32 patients will take part in the study. All patients will be treated with a modified coronally advanced tunnel. For half of them of contiguous graft will be used, for the other half a segmented graft.
Data collected will include medical history, dental and aesthetic information, clinical measurements, and a digital scan of the mouth.
The study will include the following steps:
Before the procedure: You will have a clinical and X-ray examination to determine how much your gums have receded. A digital impression of your teeth will also be taken.
Surgical procedure: You will receive a gum graft to cover the exposed roots. This involves moving gum tissue, often taken from the roof of your mouth, to the affected areas.
After the procedure: You will have several follow-up visits over a few months to check your healing and the results of the treatment.
Study timeline:
The surgery will be done once. Follow-up visits will take place 1, 3, 6, and 12 months after the surgery. The total duration of the study is about 12 months.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I or ASA II
- •Good periodontal health
- •Able to undergo oral surgery
- •Must be 18 years old and older
- •No smoking
- •At least two teeth in the same sector in the maxilla and the right and left mandible (except in the mandibular incisive sector), of which at least 2 are contiguous, with vestibular gingival recessions of type RT 1 of 1-5mm (Cairo et al. 2011)
- •An identifiable or restorable cemento-enamel junction (CEJ), with or without the presence of a non-carious cervical lesion (Pini-Prato et al. 2010)
- •Plaque index (O'Leary 1972) and bleeding index (Ainamo et al. 1975) scores of less than 20%
- •Able to give informed consent and have signed the consent forms
排除标准
- •Teeth showing recession associated with a carious lesion, restoration or cervical prosthesis involving CEJ
- •Teeth with recession depth >5mm
- •Molars with recessions will be treated but will not be taken into account for the measurements
- •Teeth with recession that have already undergone periodontal surgery
- •Presence of severe tooth malposition, rotation or significant version of the tooth
- •Smoker and ex-smoker
- •Patient suffering from a disease affecting the periodontium
- •Patient with clinical signs of active periodontitis
- •Known pregnancy in progress or breastfeeding
- •Contraindication to surgery
- •Conditions or circumstances which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
- •Patients deprived of their liberty or under legal protection
研究组 & 干预措施
Selective/Segmented graft
In this group a segmented CTG will be used
干预措施: Selective/Segmented graft (Procedure)
Continuous graft
In this group a continuous CTG will be used
干预措施: Continuous graft (Procedure)
结局指标
主要结局
Digital complete root coverage
时间窗: 3, 6 and 12 months
defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints, analysed digitally using the digital impression
次要结局
- Root-coverage Esthetic Score(3, 6 and 12 months)
- Complete Root Coverage(3, 6 and 12 months)
- Mean Root Coverage(3, 6 and 12 months)
- Keratinized Tissue Height(3, 6 and 12 months)
- Recession reduction(3, 6 and 12 months)
- Dental hypersensitivity(3, 6 and 12 months)
- Digital mean root coverage(3, 6 and 12 months)
- Digital recession reduction(3, 6 and 12 months)
- Digital Gingival soft tissues profile(3, 6 and 12 months)
- Volumetric Changes(3, 6 and 12 months)
- Patient Reported Outcome Measures(1, 2, 3, 4, 5, 6, 7, 14 days and 3, 6, 12 months)
研究者
Isabelle Laleman
Prof. Dr.
Centre Hospitalier Universitaire de Liege