| CTRI Number |
CTRI/2017/02/007949 [Registered on: 22/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Homeopathy
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of three different toothpastes (Herbal toothpaste, Homeopathy toothpaste and regular toothpaste) in prevention of dental diseases |
|
Scientific Title of Study
|
Comparing the Effectiveness of Ayurvedic, Homeopathic and Conventional Dentifrice of Plaque and Saliva- A double blind parallel design randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivashankar |
| Designation |
Post Graduate M.D.S Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
D.78 Mangali amman koli street, Muduliarpet, Pondicherry
162, P.H. Road, Velappanchavady, Chennai-77
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9003949330 |
| Fax |
|
| Email |
shiva.freee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joseph John |
| Designation |
Proffessor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
162. P.H.Road,Clinic:22, Fourth floor,
Velappanchavady, chennai-77
D.78 Mangali amman koli street, Muduliarpet, Pondicherry
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9003949330 |
| Fax |
|
| Email |
drjojohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivashankar |
| Designation |
Post Graduate M.D.S Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
D.78 Mangali amman koli street, Muduliarpet, Pondicherry
162.P.H.Road, velappanchavady, chennai-77
Pondicherry
PONDICHERRY
605004
India |
| Phone |
|
| Fax |
|
| Email |
shiva.freee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Dental college and Hospitals |
| Address |
162, P.H.Road, Velappanchavady, Chennai-600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shivashankar |
Chennai |
162 P.H Road, Velappanchavady, Chennai- 600077
Thiruvallur
TAMIL NADU |
9003949330
shiva.freee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries and Gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colgate Total |
Pea nut size of toothpaste to be used for brushing twice a day for 28 days |
| Intervention |
Dabur Meswak |
Pea nut size of toothpaste to be used for brushing twice a day for 28 days |
| Intervention |
Gumforte gel |
Pea nut size of toothpaste to be used for brushing twice a day for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Dental students, technicians and staff in the age group of 18-25 years.
2. Dental students, technicians and staff having a DMFT score lesser than 3
|
|
| ExclusionCriteria |
| Details |
1. Patients who had taken antibiotic prophylaxis for past 1 month.
2. Patients undergoing orthodontic brackets
3. Patients suffering from any systemic conditions.
4. Patients with Dental fluorosis.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival Index, Plaque pH, Saliva pH |
Baseline, 14th day and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Steptococcus mutans colony forming unit, Plaque Lactobacillus colony forming unit, Saliva Steptococcus mutans colony forming unit and Saliva Lactobacillus colony forming unit |
Baseline, 14th day and 28th day |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2016 |
| Date of Study Completion (India) |
22/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/11/2017 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aim: To compare the effectiveness of Ayurvedic, Homeopathic and Conventional dentifrices on plaque and saliva. Null Hypothesis (H0):There is no difference in the effectiveness of Ayurvedic, Homeopathic and Conventional dentifrices on plaque and saliva. Alternate Hypothesis(Ha):There is a difference in the effectiveness of Ayurvedhic, Homeopathic and Conventional dentifrices on plaque and saliva. Reason for the study: There are very less number of clinical studies comparing the effectiveness of Homeopathic, Ayurvedhic and conventional dentifrices on Dental Caries. Hence a Double blind Randomized Controlled trial is planned to evaluate the effectiveness of Homeopathic, Ayurvedhic and Conventional dentifrices on Dental caries. |