| CTRI Number |
CTRI/2022/07/044225 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An initial study for checking the effectiveness of an ayurvedic toothpaste in dirt removal from the teeth and gum disease. |
|
Scientific Title of Study
|
Evaluating the effectiveness of herbal tooth paste on dental plaque and gingival health: A pilot study |
| Trial Acronym |
HTP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anudarsh PK |
| Designation |
Postgraduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Coorg Institute of Dental Sciences,
Virajpet.
Coorg Institute of Dental Sciences, Virajpet, kodagu district, Karnataka- 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9361413518 |
| Fax |
|
| Email |
itsmedarsh25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jithesh Jain |
| Designation |
Vice principal and Head |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Coorg Institute of Dental Sciences,
Virajpet.
Coorg Institute of Dental Sciences, Virajpet, kodagu district, Karnataka- 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9448706263 |
| Fax |
|
| Email |
drjitheshjain@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anudarsh PK |
| Designation |
Postgraduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
Coorg Institute of Dental Sciences,
Virajpet.
Coorg Institute of Dental Sciences, Virajpet, kodagu district, Karnataka- 571218
KARNATAKA
571218
India |
| Phone |
9361413518 |
| Fax |
|
| Email |
itsmedarsh25@gmail.com |
|
|
Source of Monetary or Material Support
|
| JP GP marketers and consultants private limited |
|
|
Primary Sponsor
|
| Name |
Dr Anudarsh PK |
| Address |
Department of Public Health Dentistry, Coorg Institute of Dental sciences, Virajpet, Coorg, Karnataka- 571218. |
| 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 Anudarsh PK |
COORG INSTITUTE OF DENTAL SCIENCES |
Department of Public Health Dentistry,Room no: 9, Maggula, Virajpet- 571218
Kodagu
KARNATAKA |
8925129213
itsmedarsh25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Coorg Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colgate with amino shakti tooth paste |
the control group will receive Colgate with amino shakti tooth paste along with a medium tooth brush and the participants will be advised to brush twice daily for 2-3 minutes for 30 days. |
| Intervention |
Edinora prime tooth paste |
the study group will receive Edinora prime tooth paste along with a medium tooth brush and the study subjects will be advised to brush twice daily for 2-3 minutes for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals who are willing to participate in the study.
2. Males and females in good general health aged 18 to 30 years available for the duration of the study.
3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who are under antibiotics or anti-inflammatory drugs.
2. History of dental prophylaxis or treatments in the past month.
3. Individuals undergoing orthodontic treatment.
4. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
5. History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases.
6. Individuals with oral soft tissue pathology.
7. History of active or severe periodontal disease with bleeding gums and loose teeth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dental plaque and gingival health will be assessed using modified Quigley Hein plaque index and Loe H & Silness P gingival index respectively. |
baseline data on 1st day and second assessment on 15th day and final data collection on 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral hygiene will be assessed |
at the 15th day and 30th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/07/2022 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a pilot study to evaluate the effectiveness of herbal tooth paste on dental plaque and gingival health against commercially available tooth paste. Before the start of
the study, written consent will be taken from the patients. A total sample of
60 volunteers will be included in the study. The 60
volunteers will be assigned randomly into two groups, namely Group A, i.e.
the Control group and Group B i.e. the Test group equally. 30 volunteers
in Group A will receive Colgate with amino shakti tooth paste as control and 30 volunteers
in Group B will receive Edinora prime tooth paste. All the study
participants will receive a Colgate medium tooth brush for brushing. Participants
will be advised to brush twice daily for 2-3 minutes, using pea size
amount of tooth paste. The weight of
tooth paste will be measured and recorded on the first visit before the
distribution and on the last visit. On the first visit participants will be asked to report in the morning, i.e., approximately 12
hours after oral hygiene for baseline sampling. Oral
examination will be carried out and dental plaque will be assessed using modified
Quigley Hein plaque index and gingivitis will be
scored using Loe H & Silness P gingival
index. After the oral
examination, demonstration of modified bass method of brushing will be
given using a study model and later the tooth paste and tooth brush will
be distributed based on the assigned group. The oral
examination will be conducted by trained dentist and the dentist will be
blinded. Plaque
disclosing agent will be used for scoring the dental plaque. The second
visit will be on the 15th day after the initial visit and plaque index
and gingival index will be recorded. The final visit
will be on the 30th day and plaque index and gingival index
will be recorded and the participants will be asked to return the remaining
tooth paste to the researcher. All the study
participants will be blinded throughout the study. The collected
data will be used for statistical analysis and the statistician will be
blinded. |