| CTRI Number |
CTRI/2025/03/082333 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A CLINICAL STUDY ON ORAL HYGIENE WITH MADHUCA TWIG FOR BRUSHING |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON ORAL HYGIENE WITH
CONVENTIONAL BRUSHING AND MADHUCA TWIG |
| 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 Madhavi Jagat |
| Designation |
MD Scholar |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Swasthavritta Evum Yoga,
Shri NPA Govt. Ayurved
College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
94245216564 |
| Fax |
|
| Email |
drmadhavijagat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Swasthavritta Evum Yoga,
Shri NPA Govt. Ayurved
College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Associate Professor |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Swasthavritta Evum Yoga,
Shri NPA Govt. Ayurved
College Raipur
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Govt. Ayurved College Raipur (Chhattisgarh) 492010 |
|
|
Primary Sponsor
|
| Name |
Office Of Principal Shri NPA Govt Ayurved College Raipur CG |
| Address |
Department of Swasthavritta Evum Yoga, Shri NPA Govt. Ayurved
College Raipur (Chhattisgarh)
492010 |
| Type of Sponsor |
Other [Government Ayurved College] |
|
|
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 Madhavi Jagat |
Shri NPA Govt. Ayurved College and Hospital Raipur (C.G.) |
OPD No. 6 and Yoga
OPD
Shri NPA Govt.
Ayurved College Raipur
(Chhattisgarh) 492010
Raipur
CHHATTISGARH |
9425216564
drmadhavijagat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants having good health, with no severe dental or periodontal diseases.This ensures that the study focuses on prevention
rather than treatment of existing conditions. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Conventional Brushing | Conventional Brushing with Toothpaste. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Dantdhavana with Madhuca twig. , Ritucarya: -, Acara Rasayana:-, Other:60 days, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants having good health, with no severe dental or periodontal diseases (eg. No active
cavities, severe gingivitis or periodonitis). This ensures that the study focuses on prevention
rather than treatment of existing conditions.
2. Participants of age range ‘18-50 years’.This age range helps to focus on adults who can
consistently follow the study protocol.
3. Selection of participants irrespective of gender, religion, socioeconomic status and marital
status.
4. Participants should not have undergone any major dental procedures within the last 3
months.
5. Only non smokers will be included,as smoking is significant risk factor for gum disease.
6. Participants who agrees to sign consent form. |
|
| ExclusionCriteria |
| Details |
1. Individuals with active dental carries, severe gingivitis, periodontal or other significant
oral health issues will be excluded.
2. Pt. suffering from any chronic disease like oral cancer, Throat cancer.
3. Participants below the age of 18 years & above 50 years.
4. Participants who are taking antibiotics, anti-inflammatory drugs, or other medication that
can affect oral bacteria or gum health.
5. Patient who does not agree to sign a consent form.
6. Smokers or users of other tobacco products will be excluded.
7. Currently using natural twigs or other non conventional methods for oral hygiene.
8. Patients with any type of tooth cap or fillings. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral hygiene among healthy individuals is maintained. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival health maintained |
60 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| 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="1"
Months="0"
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
|
Ayurveda mainly focuses on its aim – “ Swasthasya Swasthya Rakshanam” and “Aturasya vikar Prashamanam” To achieve its first objective it is necessary to focus on implement of Ritucharya and Dincharya. Acharya have given more importance to Dinacharya and Ritucharya which describes the daily routine to be followed by a healthy individual for maintaining the health. Ayurveda has given more importance to oral hygiene. It has mentioned many procedures for maintenance of oral health which includes Dantadhavana, Jihwanirlekhana, Kavala, Gandusha etc. Acharya Caraka further adds use of herbal twigs or datun helps to get rid of mukha daurgandya,use of datun remove mal from teeth, tongue, mukha and activate taste buds. One should brush ones teeth with the twig of neem, madhuca, khadir, karanj etc. Madhuka has Madhura, Sita and Snigdha properties. It acts as Vata- pitta hara and Raktapittahara. According to Acharya Sushrut Madhuca is best amongst Madhur ras gana, Acharya Sushruta also describes these properties. Acharya Sushrut explains its useful properties in maintaining oral hygiene.According to sushrut madhura ras dantdhavani can be used in Pittaj vikar e.g mukha pak,mukha dah etc. Madhuca twigs are known for their natural antiseptic,antibacterial,spasmolytic and insecticidal properties.A scientific investigation into these properties can offer a natural, chemical-free alternative to conventional dental care products.
AIM: The aim of this study is to compare the effectiveness of conventional brushing with the use of Madhuca (Madhuca longifolia) twigs in maintaining oral hygiene among healthy individuals.
OBJECTIVES: 1.To measure and compare the levels of gingival health, and overall oral cleanliness between individuals using conventional brushing and those using Madhuca twigs. 2.To determine the effectiveness of Madhuca twigs in maintaining or improving oral hygiene in comparison to conventional toothbrushes. 3.To evaluate the difference in oral hygiene scores between the two groups. 4.To identify any additional benefits or limitations of using Madhuca twigs over those using conventional brushing, including cost-effectiveness, accessibility, and cultural relevance. |