| CTRI Number |
CTRI/2024/04/066377 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of custom made handle to maintain oral hygiene in elderly population |
|
Scientific Title of Study
|
EFFICACY OF CUSTOMIZED TO0THBRUSH HANDLE IN MAINTAINING ORAL
HYGIENE AMONG GERIATRIC POPULATION WITH LIMITED MANUAL
DEXTERITY- ARANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr STEHEN VIJAY NIRMAL T |
| Designation |
post graduate student |
| Affiliation |
Tamailnadu Govt Dental College and Hospital |
| Address |
G-3, Department of Public Health Dentistry, Tamailnadu Govt Dental College and Hospital, No.1, TNPSC road, opp. to fort station, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
627657
India |
| Phone |
9788914360 |
| Fax |
|
| Email |
stephenvijaynirmal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SG Ramesh Kumar |
| Designation |
Senior Assistant Professor |
| Affiliation |
Tamailnadu Govt Dental College and Hospital |
| Address |
G-3, Department of Public Health Dentistry, Tamailnadu Govt Dental College and Hospital, No.1, TNPSC road, opp. to fort station, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9840792950 |
| Fax |
|
| Email |
ramesh172000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SG Ramesh Kumar |
| Designation |
Senior Assistant Professor |
| Affiliation |
Tamailnadu Govt Dental College and Hospital |
| Address |
G-3, Department of Public Health Dentistry, Tamailnadu Govt Dental College and Hospital, No.1, TNPSC road, opp. to fort station, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9840792950 |
| Fax |
|
| Email |
ramesh172000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsor -
Tamilnadu Government Dental college and hospital, Chennai - 03 |
|
|
Primary Sponsor
|
| Name |
Dr. Stephen Vijay Nirmal. T |
| Address |
G-3, Department of Public Health Dentistry, Tamailnadu Govt Dental College and Hospital, No.1, TNPSC road, opp. to fort station, Chennai, Tamil Nadu 600003 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Stephen Vijay Nirmal T |
Tamilnadu Govt Dental College and Hospital |
Room no G-3, Department of Public Health Dentistry, No.1, TNPSC road, opp. to fort station, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU |
9788914360
stephenvijaynirmal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL REVIEW BOARD- TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
geriatric population |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Toothbrush |
Standard Toothbrush for 30 days then crossover with intervention agent |
| Intervention |
Standard Toothbrush with customized toothbrush handle
|
Standard Toothbrush with customized toothbrush handle for 30 days with crossover with comparator |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with weak hand grip measured by dynamometer.
Patients with a minimum of 20 teeth |
|
| ExclusionCriteria |
| Details |
Individuals requiring caregiver-assisted brushing.
Mentally challenged individuals.
Individuals with any medical conditions affecting the motor functions of the orofacial region. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical evaluation of oral health status by Patient performance index, Turskey Gillmore Glickman modification of Plaque index and Gingival index will be recorded. |
30 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The ease, comfort and satisfaction levels of use with customized handles subjectively. |
30 days
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |