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临床试验/NCT06365983
NCT06365983Unknown不适用

Comparison of Free Gingival Graft and Linear Incision Techniques to Obtain Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: a 12-month Non-inferiority Randomized Trial

Federal University of Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
1
主要终点
Percentage of root coverage

研究概览

简要总结

A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.

Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.

Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.

All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.

Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.

INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.

EXCLUSION CRITERIA

Individuals will not be considered eligible if they:

  • Present any form of immunological compromise;
  • Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
  • Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
  • Are current or ex-smokers;
  • Have allergies to ibuprofen and chlorhexidine digluconate.

Research Objective:

PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.

SECONDARY OBJECTIVE

Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes.

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
Single (Outcomes Assessor)

盲法说明

All sample randomization procedures will be carried out by a researcher not involved in treatments and clinical examinations. An external researcher not affiliated with the study will be responsible for maintaining participant allocation confidentiality. Sides will be identified by numbers stored in opaque, sealed envelopes with the randomization sequence. Outcome assessors will be blinded to the experimental group to which participants belong.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.

排除标准

  • •Individuals will not be considered eligible if they:
  • •Present any form of immunological compromise;
  • •Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
  • •Present active periodontitis, defined by presence of >=10% subgingival bleeding and probing depth and clinical attachment loss proximal >4mm (Tonetti et al. 2018);
  • •Are current or ex-smokers;
  • •Have allergies to ibuprofen and chlorhexidine digluconate.

研究组 & 干预措施

Linear Incision

Experimental

干预措施: Connective Tissue with Linear Incision (Procedure)

Free Gingival Graft

Active Comparator

干预措施: Connective Tissue with Free Gingival Graft (Procedure)

结局指标

主要结局

Percentage of root coverage

时间窗: 12 months

Final minus baseline recession depth divided by baseline value

次要结局

  • Recession depth(Baseline, 3, 6, 9 e 12 months)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Nogueira Haas

Professor

Federal University of Rio Grande do Sul

研究点 (1)

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