| CTRI Number |
CTRI/2024/04/066218 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of conventional toothpaste with herbal toothpaste tablets in reduction of plaque and gingivitis. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of herbal toothpaste tablets over
standard toothpaste in reduction of plaque and gingivitis- A randomized controlled 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 |
Dr Haritha Avula |
| Designation |
Professor & Head,Department of Periodontics and Implantology |
| Affiliation |
SRI BALAJI DENTAL COLLEGE |
| Address |
Department of Periodontics
Sri Balaji Dental College Yenkapally village
Moinabad mandal
Ranga Reddy district
Telangana- 500075
India
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500075
India |
| Phone |
9885446656 |
| Fax |
|
| Email |
harithaavula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haritha Avula |
| Designation |
Professor & Head,Department of Periodontics and Implantology |
| Affiliation |
SRI BALAJI DENTAL COLLEGE |
| Address |
Department of Periodontics
Sri Balaji Dental College Yenkapally village
Moinabad mandal
Ranga Reddy district
Telangana- 500075
India
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500075
India |
| Phone |
9885446656 |
| Fax |
|
| Email |
harithaavula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fatima Al Farooqui |
| Designation |
Post Graduate |
| Affiliation |
SRI BALAJI DENTAL COLLEGE |
| Address |
Department of Periodontics
Sri Balaji Dental College
Yenkapally village
Moinabad mandal
Ranga Reddy district
Telangana- 500075
India
Hyderabad
TELANGANA
Hyderabad
TELANGANA
500075
India |
| Phone |
9490377220 |
| Fax |
|
| Email |
drfatimaalfarooqui@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI BALAJI DENTAL COLLEGE
Yenkapally village
Moinabad mandal
Ranga Reddy district
Telangana- 500075
India
|
|
|
Primary Sponsor
|
| Name |
Dr. Haritha Avula |
| Address |
Department of periodontics Sri Balaji dental college Yenkapally Moinabad Ranga
reddy district Telangana 500075 India |
| 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 Haritha Avula |
SRI BALAJI DENTAL COLLEGE |
Room number-09
Department of Periodontics
Sri Balaji Dental College
Yenkapally village
Moinabad mandal
Ranga reddy district
Telangana 500075
India
Hyderabad
TELANGANA |
9885446656
harithaavula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE, SRI BALAJI DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COLGATE TOTAL TOOTHPASTE |
BRUSHING TWICE DAILY BY USING COLGATE TOOTHPASTE FOR ONE MONTH. |
| Intervention |
HERBAL TOOTHPASTE TABLETS. |
BRUSHING TWICE DAILY BY USING TOOTHPASTE TABLETS FOR ONE MONTH. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Males or females ≥ 18 years of age with a minimum of 25 teeth
2. Baseline mean whole-mouth plaque index ≥ 1.0
3. Baseline mean whole-mouth modified gingival index ≥ 1.0
4. Baseline mean whole-mouth modified sulcular index ≥ 1.0
5. Ability to provide written informed consent and comply with
study visits as described in the protocol, and
6. Availability for follow up via telephone. |
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. Participation in another clinical trial
3. History of periodontitis
4. History of any systemic diseases or conditions |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI): Quigley Hein with Turesky modification
2. Modified Gingival Index (MGI)
3. Modified Sulcus Bleeding Index (mSBI) |
Baseline
15th day
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of herbal toothpaste tablets compared to conventional toothpaste. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
01/05/2025 |
| 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="4"
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
|
Gingivitis is a non- specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Regular oral hygiene practices could significantly reduce plaque accumulation and gingival inflammation. Toothpaste is the most widely utilized and an effective oral hygiene aid. Toothpaste tablets are a relatively new form of toothpaste that can be a viable alternative to conventional dentifrice. Tablets are more environmentally friendly in comparison to toothpaste. Tablets are a dry formulation containing all the ingredients required for tooth care. Chewable toothpaste tablets have the advantage of being able to be unpacked and put into the mouth, then chewed off and brushed with a wet toothbrush. The use of herbal products in dentifrice is proving to be a potential and effective competitor to conventional synthetic compounds. In light of the above advantages, the present study attempts to compare and evaluate the efficacy of commercially available herbal toothpaste tablets and regular toothpaste in the reduction of plaque and gingivitis. |