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临床试验/CTRI/2025/08/093098
CTRI/2025/08/093098尚未招募不适用

Xylitol Chewing-Gum Versus Moisturizing Mouthwash: A Comparative Study on Dry Mouth Relief for Hypertensive and Diabetic Patients

Sibar institute of dental sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the effectiveness of xylitol-containing chewing gum and moisturizing mouthwash in reducing dry mouth symptoms among hypertensive and diabetic patients.

研究概览

简要总结

40 Participants with hypertension and diabetes experiencing xerostomia will be selected. Subjects will be explained the entire procedure and written consent is obtained from each of them. The subjects will be selected based on inclusion and exclusion criteria. A purposive sampling technique will be employed in this study. Demographic characteristics of the study participants will be obtained. Participants will be randomly allocated into two groups (n=20 each). Group-1 will receive xylitol-containing chewing gum, Group-2 will receive moisturizing mouthwash. Dry mouth scores were recorded subjectively and objectively at baseline, immediately after the first use, after 7 days of continued use. Participant feedback was gathered using the Product Performance and Attributes Questionnaire (PPAQ).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Individuals who have been diagnosed with hypertension, diabetes or both Individuals who are under medication for hypertension and diabetes for at least 1 year and show symptoms of dry mouth according to Clinical Oral Dryness score (CODS) Patients who provide consent.

排除标准

  • Newly diagnosed hypertensive and diabetic cases.
  • Individuals who are prone to allergy.
  • Individuals who smoke and consume alcohol.
  • Patients with systemic diseases and treatment other than hypertension and diabetes, Patients who are un cooperative and not willing to participate.
  • Patients who are mentally unstable.

结局指标

主要结局

To compare the effectiveness of xylitol-containing chewing gum and moisturizing mouthwash in reducing dry mouth symptoms among hypertensive and diabetic patients.

时间窗: at baseline, immediately after 1st use and after 7 days use

次要结局

  • To evaluate the effectiveness of xylitol-containing chewing gum & moisturizing mouthwash in alleviating dry mouth symptoms among hypertensive & diabetic patients, & to assess patient-reported satisfaction with both.(at baseline, immediately after 1st use & after 7 days use)

研究者

发起方
Sibar institute of dental sciences
申办方类型
Other [Private dental college]
责任方
Principal Investigator
主要研究者

Dr Kukkala Ujwala

Sibar institute of dental sciences

研究点 (1)

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