| CTRI Number |
CTRI/2026/01/100743 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare toothpaste tablets with regular toothpaste in assessing dental plaque and gum problems among patients |
|
Scientific Title of Study
|
A comparative evaluation of toothpaste tablets and a conventional toothpaste in assessing supragingival plaque and gingivitis among patients in Nellore city, Andhra Pradesh: A randomized clinical 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 |
Devangam Vimalakshi |
| Designation |
Postgraduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Public Health Dentistry, room no- 9, Narayana Dental College and Hospital, chinthareddypalem, Nellore
Department of Public Health Dentistry, room no- 9, Narayana Dental College and Hospital, chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9398578802 |
| Fax |
|
| Email |
devangamvimalakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RVS Krishna Kumar |
| Designation |
Head of the department and professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Public Health Dentistry, Room no-9, Narayana Dental College And Hospital, Chinthareddypalem, Nellore
Department of Public Health Dentistry, Room no-9, Narayana Dental College And Hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9885291980 |
| Fax |
|
| Email |
drkkmds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Devangam Vimalakshi |
| Designation |
Post Graduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department Of Public Health Dentistry, room no-9, Narayana Dental College And Hospital, Chinthareddypalem, Nellore
Department Of Public Health Dentistry, room no-9, Narayana Dental College And Hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9398578802 |
| Fax |
|
| Email |
devangamvimalakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Devangam Vimalakshi |
| Address |
Narayana Dental College and hospital, Chinthareddypalem, Nellore |
| 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 |
| Vimalakshi Devangam |
Narayana Dental College and Hospital |
Department Of Public Health Dentistry, room no-9, Narayana Dental College and Hospital, Nellore
Nellore
ANDHRA PRADESH |
9398578802
vimalakshidevangam98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee,Narayana dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tooth Paste |
To compare the plaque removal efficacy and Gingivitis between tooth paste and tooth paste tablets for the duration of 28 days and frequency twice |
| Intervention |
Tooth Paste Tablet |
To Compare the plaque removal efficacy and gingivitis between tooth paste tablets and toothpaste for the duration of 28 days and frequency twice |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects are 20 years or older
3. Subjects who can read and understand the consent form
4. Subjects available during the study period
5. Subjects have more than 20 teeth. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant and/or nursing;
2. Subjects under the age of 20.
3. subjects who are not willing to participate
4. subjects having orthodontic braces or appliances |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in supragingival plaque levels assessed using Oleary plaque control record |
Baseline and after 28 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in gingival inflammation assessed using Loe & Silness gingival index |
Base line & after 28 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="2"
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
|
This study is planned to evaluate and compare the effectiveness of toothpaste tablets and conventional toothpaste in controlling supragingival plaque and gingivitis among adults. Dental plaque and gingival inflammation are common oral health problems and are influenced by daily oral hygiene practices. Toothpaste tablets have been introduced as an alternative to conventional toothpaste and are promoted as an eco friendly and convenient oral hygiene product. However scientific evidence regarding their effectiveness in plaque and gingivitis control is limited. The study will be conducted among adults aged 20 to 65 years who satisfy the inclusion criteria and provide informed consent. Eligible participants will be randomly allocated into two groups. One group will be instructed to use toothpaste tablets while the other group will use conventional toothpaste for a specified study period. All participants will receive standardized oral hygiene instructions at the beginning of the study. Clinical assessment of oral hygiene status will be carried out at baseline and after the intervention period using standard indices for recording supragingival plaque and gingival status. The change in plaque and gingival scores will be compared between the two groups to determine the effectiveness of the interventions. The findings of this study are expected to provide scientific evidence regarding the effectiveness of toothpaste tablets in comparison with conventional toothpaste. The results may help dental professionals and the general population in making informed decisions regarding the use of toothpaste tablets as an alternative oral hygiene aid. |