| CTRI Number |
CTRI/2025/03/082262 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of manual toothbrush and powered toothbrush |
|
Scientific Title of Study
|
To evaluate the effectiveness of manual toothbrush in comparison with powered toothbrush |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sodisetti soniya syamu |
| Designation |
undergraduate student |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, St joseph dental college, Duggirala, Eluru.
West Godavari
ANDHRA PRADESH
533403
India |
| Phone |
09493650695 |
| Fax |
|
| Email |
anjalivanapamala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Harish Prabhudev |
| Designation |
Reader |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, st joseph dental college, duggirala, eluru.
West Godavari
ANDHRA PRADESH
533403
India |
| Phone |
8019907259 |
| Fax |
|
| Email |
devsdental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Harish Prabhudev |
| Designation |
Reader |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, st joseph dental college, duggirala, eluru.
West Godavari
ANDHRA PRADESH
533403
India |
| Phone |
8019907259 |
| Fax |
|
| Email |
devsdental@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Joseph dental college, Duggirala, Eluru, Andha pradesh, India, 534003 |
|
|
Primary Sponsor
|
| Name |
VANAPAMALA GNANA KUSUMANJALI |
| Address |
St. Joseph dental college, Duggirala, Eluru, Andha pradesh, India, 534003 |
| Type of Sponsor |
Other [VANAPAMALA GNANA KUSUMANJALI] |
|
|
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 Vanapamala Gnana kusumanjali |
St. Joseph dental college |
Department of periodontics, room number 8, st joseph dental college, duggirala, eluru,Andhra pradesh, India, 534003.
West Godavari
ANDHRA PRADESH |
09493650695
anjalivanapamala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe St Joseph dental college & hospital duggirala eluru west godavari district Andhra pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
plaque index |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age range 25 to 50 years.
2. Good systemic health.
3. Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with intellectual inability to comprehend and comply with the aims of the study.
2. Mentally disabled patients with compromised hand dexterity
3. Pregnant, Lactating mothers.
4. History of smoking and alcohol abuse.
5. Inability or unwillingness to complete the trial.
6. Patients on any medication that could affect or alter the course of periodontal treatment |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Turesky, Gilmore, Glickman modification of the Quigley- Hein plaque index |
Before phase I periodontal therapy and also on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical attachment level |
Before phase I periodontal therapy and also on 14th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - anjalivanapamala@gmail.com
- For how long will this data be available start date provided 13-03-2025 and end date provided 15-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aimed to compare the effectiveness of manual toothbrush and powered toothbrush in terms of plaque control. A 20 systematically healthy individuals who are willing to participate in the study with age range 25 to 50 years will be assigned randomly into 2 groups in which Group
one with the 10 patients receives phase I periodontal therapy followed by oral
hygiene instructions. Patients will be instructed to use electric brush (Caresmith SPARK One Electric Battery Toothbrush) as
an oral hygiene aid. Group two with the 10 patients receives phase
I periodontal therapy followed by oral hygiene instructions. Patients will be instructed to use manual
toothbrush (Oral B soft bristled toothbrush) as an oral hygiene aid. Both the groups will be instructed to brush
twice a day using modified bass method. Subjects of 2 groups will be assessed for
plaque control using Turesky, Gilmore,
Glickman modification of the Quigley- Hein plaque index after staining with
plaque disclosing solution before phase I periodontal therapy and also on 14th day. |