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临床试验/CTRI/2024/04/066377
CTRI/2024/04/066377尚未招募2 期

EFFICACY OF CUSTOMIZED TO0THBRUSH HANDLE IN MAINTAINING ORAL HYGIENE AMONG GERIATRIC POPULATION WITH LIMITED MANUAL DEXTERITY- ARANDOMIZED CONTROLLED TRIAL.

Dr. Stephen Vijay Nirmal. T1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Clinical evaluation of oral health status by Patient performance index, Turskey Gillmore Glickman modification of Plaque index and Gingival index will be recorded.

研究概览

简要总结

Participants aged 65 years and above will be recruitment in public dental teaching institution and old age homes who are satisfying the eligibility criteria are recruited for the present study. Patients with weak hand grip measured by a dynamometer. The study participants are clearly informed about the purpose of the study by providing patient information sheet. Written informed consent is obtained from the study participants. The study participants are clearly informed about the purpose of the study by providing patient information sheet. Written informed consent is obtained from the study participants. Computerized random allocation of 50 participants into group 1(25 participants), group 2 (25 participants)  Oral prophylaxis will be done Baseline evaluation of periodontal health status by Turskey-Gillmore Glickman modification of Plaque index and gingival index. Then the participants are randomly allocated into two groups. Group 1 will receive Standard Toothbrush and standard toothpaste and Group 2 will receive Standard Toothbrush with customized handle and standard toothpaste for 4 weeks.  After 4 weeks Clinical evaluation of oral health status by Patient performance index, Turskey Gillmore Glickman modification of Plaque index and Gingival index will be recorded. Patient satisfaction level assessed.  Then Oral prophylaxis will be done and baseline assessment will be done followed by cross-over of intervention.  Group 1 will receive Standard Toothbrush with customized handle and standard toothpaste and Group 2 will receive Standard Toothbrush with standard toothpaste  for 4 weeks.  After 4 weeks Clinical evaluation of oral health status by Patient performance index, Turskey Gillmore Glickman modification of Plaque index and Gingival index will be recorded. Patient satisfaction level assessed. Then analysis will be done.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
65.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients with weak hand grip measured by dynamometer.
  • Patients with a minimum of 20 teeth.

排除标准

  • Individuals requiring caregiver-assisted brushing.
  • Mentally challenged individuals.
  • Individuals with any medical conditions affecting the motor functions of the orofacial region.

结局指标

主要结局

Clinical evaluation of oral health status by Patient performance index, Turskey Gillmore Glickman modification of Plaque index and Gingival index will be recorded.

时间窗: 30 days follow up

次要结局

  • The ease, comfort and satisfaction levels of use with customized handles subjectively.(30 days)

研究者

发起方
Dr. Stephen Vijay Nirmal. T
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr STEHEN VIJAY NIRMAL T

Tamailnadu Govt Dental College and Hospital

研究点 (1)

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