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临床试验/NCT07118111
NCT07118111进行中(未招募)不适用

The Role of Resin Infiltration Treatment on Dental Hypersensitivity and Patient-Parent Satisfaction in Children With Anterior Teeth Affected by Hypomineralization or Hypoplasia

Gizem Tıraşçı1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Change in Dental Hypersensitivity and Patient-Parent Satisfaction

研究概览

简要总结

This study evaluates the effect of resin infiltration on dental sensitivity, quality of life, and satisfaction in children aged 7-14 with enamel defects in their front teeth. Forty children received treatment, and outcomes were measured through sensitivity tests and questionnaires for both children and parents.

详细描述

Developmental enamel defects can negatively impact oral health-related quality of life by causing esthetic concerns and dental hypersensitivity in children. This prospective clinical study included 40 children aged 7-14 years diagnosed with hypomineralization or hypoplasia in their anterior teeth. All participants received resin infiltration treatment. Dental hypersensitivity was evaluated pre- and post-treatment using the Schiff Cold Air Sensitivity Scale (SCASS). Oral health-related quality of life was assessed using the Pediatric Oral Health-Related Quality of Life (POQL) scale through both child and parent forms. Post-treatment esthetic satisfaction levels were recorded based on reports from both children and their parents. The study aimed to determine the impact of resin infiltration on improving sensitivity, quality of life, and satisfaction in this population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged between 7 and 14 years.
  • •Children in good general health without any systemic disease.
  • •Presence of at least one anterior permanent tooth with hypomineralization or hypoplasia.
  • •Teeth with lesions larger than 1 mm that are suitable for resin infiltration treatment.
  • •Voluntary participation of both the child and their parent/guardian in the study, with signed informed consent.

排除标准

  • •Children with systemic diseases or undergoing medical treatment.
  • •Cases with active caries, trauma, restorations, or endodontic treatment applied or required on anterior teeth.
  • •Individuals who have previously received resin infiltration or similar treatment on the same tooth.
  • •Children with a history of allergies or sensitivity to the materials used in the procedure.
  • •Individuals who have received interventions such as fluoride varnish, fissure sealants, or tooth whitening on their teeth.
  • •Children who do not possess the cognitive ability to understand and respond to the questionnaire or sensitivity assessment.

研究组 & 干预措施

Resin Infiltration Treatment Group

Other

All participants receive resin infiltration treatment to anterior teeth affected by enamel defects.

干预措施: Resin infiltration (Procedure)

结局指标

主要结局

Change in Dental Hypersensitivity and Patient-Parent Satisfaction

时间窗: 1 month, 3 months, and 6 months after treatment

Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment. Schiff Cold Air Sensitivity Scale (SCASS): 0 - The patient does not respond to the air stimulus. 1. - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.

Change in Dental Hypersensitivity and Patient-Parent Satisfaction

时间窗: Baseline, 1 month, 3 months, and 6 months after treatment

Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment. Schiff Cold Air Sensitivity Scale (SCASS): 0 - The patient does not respond to the air stimulus. 1. - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.

次要结局

  • ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance(Baseline, 1 month, 3 months, and 6 months after treatment)
  • ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance(Baseline, 1 month, 3 months, and 6 months after treatment)

研究者

发起方
Gizem Tıraşçı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gizem Tıraşçı

Research Assistant

Inonu University

研究点 (1)

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