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临床试验/NCT06830434
NCT06830434已完成不适用

Aesthetic Crown Lengthening: Laser Impact on Pain Perception and Surgery Impact on Self-esteem and Quality of Life Perceptions

University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Patients' levels of self-esteem and quality of life

研究概览

简要总结

Gummy smile is a condition that promotes a disharmonious smile, altering confidence and decreasing self-esteem of many patients. Luckily, this problem in most cases is easily solved by aesthetic crown lengthening surgery. However, this is a surgery that is still considered by many patients to be painful and uncomfortable. Thereby, this study seeks both to evaluate possible changes in patients' self-esteem and self-confidence after the aesthetic crown lengthening surgery.

详细描述

Periodontally healthy patients who expressed interest in undergoing ACL will be selected. Before surgery, two questionnaires will be administered: the OHIP-14/Brazil and the Rosenberg Self-Esteem Scale-UNIFESP/EPM. These tools are designed to assess patients' perceptions of self-esteem and quality of life and will be re-administered 30 days and one year after surgery.

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, Care Provider, Outcomes Assessor)

盲法说明

Laser therapy will be performed in a blinded manner for the patients. The crown lengthening surgeon and the outcomes assessor will also be blinded-they will not know which side received the laser therapy. Only the laser operator will have access to this information. The quadrant receiving the therapy will be randomly selected using a computer program by the laser operator.

入排标准

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

入选标准

  • Periodontal health diagnosis (full mouth bleeding on probing - BP <10%, clinical attachment level - CAL ≤ 3mm),
  • Distance from the gingival margin to the cementum-enamel junction ≥ 3mm associated with a gingival smile and / or short clinical crowns when compared to anatomical crowns, due to the altered passive eruption or gingival overgrowth).
  • Good general health

排除标准

  • Presence of systemic changes (diabetes, heart disease, hepatitis, etc.)
  • Use of medications (such as antibiotics, continuous anti-inflammatory drugs, phenytoin, cyclosporine) that may influence the response to the surgical treatment
  • Diagnosis of gingivitis and/or periodontitis
  • Smoking habit
  • Pregnancy or lactation period

结局指标

主要结局

Patients' levels of self-esteem and quality of life

时间窗: From enrollment through study completion, an average of 2 years

The perceptions of self-esteem and quality will be measured through the OHIP-14/Brazil and the Rosenberg/UNIFESP-EPM Self-Esteem Scale questionnaires.The Rosenberg questionnaire addresses an individual's overall sense of self-worth and self-acceptance, evaluating both positive and negative self-perception domains to provide a holistic view of their self-esteem. It consists of 10 statements rated on a 4-point Likert scale, with responses ranging from 'Strongly Agree' to 'Strongly Disagree.' Scores range from 0 to 30, where higher scores indicate greater self-esteem, while lower scores suggest diminished self-worth or a negative self-view. The OHIP-14 (Oral Health Impact Profile-14) questionnaire evaluates the impact of oral health on an individual's quality of life. It measures functional and psychological well-being across seven domains to assess how oral conditions affect daily life and overall well-being.

次要结局

未报告次要终点

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renato Casarin

Professor

University of Campinas, Brazil

研究点 (2)

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