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临床试验/NCT07188142
NCT07188142尚未招募2 期

Investigating the Effects of Two Different Desensitizing Agents on Mitigating Post-Operative Sensitivity Following Composite Restorations - a Randomized Controlled Trial

Beenish Hassan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Post-operative sensitivity

研究概览

简要总结

  • The aim of this study is to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -Patients visiting OPD will be selected after fulfilment of inclusion criteria. Patients aged 18-45 meeting inclusion criteria and presenting with active primary class I carious lesions on vital molar teeth with ICDAS score 3 will be randomly assigned into two groups: -Group A: Patients will be provided with Gluma desensitizer, Universal Bonding agent and Composite restoration and -Group B: Patients will receive Universal bonding agent and Composite restoration. -The progress of treatment will be followed up immediately (baseline) and at regular follow up visits at 1 week, 1 month and 3 months.
  • Post-operative sensitivity will be assessed using an air stimulus and rated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10.

详细描述

-This randomized clinical trial is done to compare the effectiveness of Gluma desensitizer in reducing post-operative sensitivity following composite restorations in posterior teeth. -The study sample size includes a total of 60 participants aged 18 to 45, each having two Class I carious lesions requiring composite restorations. -Patients will be randomly divided into two groups using a lottery method: -Group A receiving Gluma desensitizer, universal bonding agent, and composite restoration, and -Group B receiving universal bonding agent and composite restoration without desensitizer. -Patients will be selected from the outpatient dental clinic after fulfilling inclusion criteria, which include age between 18 and 45 years, good oral hygiene, active primary Class I carious lesions on vital molar teeth with an ICDAS score of 3, complaints of sensitivity to air and osmotic stimulus, positive response to cold test, and no signs of pulp inflammation or spontaneous pain before treatment. -Exclusion criteria include excessive tooth wear due to clenching or abnormal habits, traumatic occlusion, periodontal or gingival disease, and current use of analgesics and/or anti-inflammatory medication. -Post-operative sensitivity will be measured clinically using an air stimulus and evaluated on a numeric rating scale for post-operative sensitivity assessment ranging from 0 to 10. ranging from 0 (no sensitivity) to 10 (unbearable sensitivity) at baseline (immediately after treatment) and at 1 week, 1 month, and 3 months postoperatively. -Statistical analysis will be performed using non-parametric tests including the Friedman test for within-group comparisons and Wilcoxon signed-rank test for between-group differences, with significance set at p < 0.05. -This study will further add to the literature by providing clinical evidence regarding the efficacy of Gluma desensitizer in reducing post-operative sensitivity and improving patient comfort following restorative dental procedures.

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-45 years.
  • Good oral hygiene.
  • Active primary class I carious lesions on vital molar teeth with ICDAS score 3
  • Patients complaining of sensitivity to air and osmotic stimulus.
  • Teeth having a positive cold test.
  • No signs of pulp inflammation or spontaneous pain before treatment.

排除标准

  • Excessive tooth wear due to clenching or abnormal habits.
  • Traumatic occlusion.
  • Periodontal or gingival disease.
  • Patients using analgesics and/or anti-inflammatory medicine.

结局指标

主要结局

Post-operative sensitivity

时间窗: 3 months

Change in dentinal hypersensitivity following Class I composite restorations, measured using a numeric rating scale to evaluate Post-operative Sensitivity (0-10) (0: No sensitivity, 10: Unbearable sensitivity) in response to air stimulus at baseline, 1 week, 1 month and 3 months post-treatment.

次要结局

未报告次要终点

研究者

发起方
Beenish Hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Beenish Hassan

Post Graduate Trainee

Margalla Institute of Health Sciences

研究点 (1)

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