| CTRI Number |
CTRI/2018/01/011253 [Registered on: 10/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to assess the Efficacy and Safety of Ayurvedic Dant Manjan |
|
Scientific Title of Study
|
An Open Label, Single arm, Monocentric Clinical Study to evaluate Efficacy and Safety of Ayurvedic Dant Manjan. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SBS/0917/DMJN Version 1.0 Dt: 12th September 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep Balerao |
| Designation |
Consultant Dental Surgeon |
| Affiliation |
Holistic Health Care and Research Centre |
| Address |
3-1-230, Nimboliadda, Kachiguda, Hyderabad
Hyderabad
ANDHRA PRADESH
500027
India |
| Phone |
04024738805 |
| Fax |
|
| Email |
vjyo2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinivas Lanka |
| Designation |
Head Clinical Research |
| Affiliation |
Sanjeevani Bio Services Pvt. Ltd. |
| Address |
302, Mahindra Residency,
Ameerpet, Hyderabad
Hyderabad
ANDHRA PRADESH
500016
India |
| Phone |
04065794774 |
| Fax |
|
| Email |
srinivas.lanka@sanjeevanibio.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamal Kammili |
| Designation |
Manager |
| Affiliation |
Sanjeevani Bio Services Pvt. Ltd. |
| Address |
302, Mahindra Residency,
Ameerpet, Hyderabad
Hyderabad
ANDHRA PRADESH
500016
India |
| Phone |
04065794774 |
| Fax |
|
| Email |
kamal.kammili@sanjeevanibio.com |
|
|
Source of Monetary or Material Support
|
| Manisha Sales,
1301/A Binaki Layout, Vaishali Nagar Nagpur - 440017
Maharashtra State,
India |
|
|
Primary Sponsor
|
| Name |
Manisha Sales |
| Address |
1301/A Binaki Layout, Vaishali Nagar Nagpur - 440017
Maharashtra State,
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pradeep Balerao |
Holistic Health Care and Research Centre |
3-1-230, Nimboliadda, Kachiguda, Hyderabad
Hyderabad
ANDHRA PRADESH |
04024738805
vjyo2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S2J INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gingivitis,
Dental Plaque,
Teeth Stains,
Bad Oral Breath,
Teeth Sensitivity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL / Not Applicable |
NIL / Not Applicable |
| Intervention |
Vithoba Ayurvedic Dant Manjan |
Each 100 gm Contains:
1.Sodii biboras - 9 gm
2.Terminalia belerica - 10.5 gm
3.Sodii chloridum - 5.4 gm
4.Camphora - 1.5 gm
5.Caryophyllus aromaticus Linn - 0.75 gm
6.Acacia arabica - 6.27 gm
7.Sphaticalahi - 10 gm
8.Mentha piperata Linn - 0.75 gm
9.Piper nigrum Linn - 0.83 gm
10.Swarnagourica - 5 gm
11.Khatica - q.s. base |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Men and women (age 18-60 years) who are suffering with dental health problems
2)At least 20 natural teeth suitable for evaluation
3)Subjects having gingivitis with gingival index > 1
4)Subjects having dental plaque with plaque index of 2 or more
5)Able and willing to sign approved informed consent |
|
| ExclusionCriteria |
| Details |
1)Females disagree to birth control measure for the duration of the study
2)Known allergy to constituents of the formulation of toothpowder.
3)Subjects with preexisting systemic diseases necessitating long term medications
4)Subjects having advanced Dental disease
5)Subjects having diseases of soft /hard tissues
6)Subjects Having fixed orthodontic appliances (including permanent orthodontic retainers)
7)Subjects with Abnormal salivary function
8)Having any acute /chronic systemic illness
9)Subjects who have the habit of consuming alcohol, smoking, chewing gums, pan or gutka.
10)Pregnant or lactating Females
11)Antibiotic use in the last 3 months
12)Routine use of anticoagulant medication
13)Routine use of anti-inflammatory medication
14)Routine use of medications known to have effects on the gingiva (e.g., phenytoin etc)
15)Routine use of medications inhibiting or stimulating salivary flow
16)Physical handicap that could interfere with daily performance of oral hygiene
17)Participation in any other study during the study period of this trial
18)Routine use of any mouthrinse
19)Routine use of any interdental cleaning device (floss, dental toothpicks)
20)Having probing depth ≥4 mm at any site
21)Having had active periodontal therapy during the last 6 months
22)Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months
23)More than 3 carious lesions requiring immediate care
24)Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The measurement of changes in the Gingival Index Score at the end of the study as compared to the baseline. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The measurement of changes in the Quigley – Hein (Tuersky) Index Score of plaque at the end of the study as compared to the baseline. |
28 days |
| The measurement of changes in the Lobene Index Score of stain at the end of the study as compared to the baseline. |
28 days |
| The measurement of bad breath using organoleptic method. |
28 days |
| The measurement of tooth sensitivity in patients who have sensitive teeth using tactile stimulus test |
28 days |
| Assessment of Adverse Events associated with the treatment. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/10/2017 |
| Date of Study Completion (India) |
28/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was an open label, interventional, trial evaluating the safety and efficacy of Ayurvedic Dant manjan in 40 patients with Dental Health Conditions such as Gingivitis, Plaque, Teeth Stains, Bad Breath and Tooth Sensitivity that has been conducted in single center in India. The primary outcome measure was Improvement in Dental Health Symptoms of Gingivitis as compared to baseline visit. The secondary outcome measures were Improvement in Dental Health Symptoms of Plaque, Teeth Stains, Bad Breath and Tooth Sensitivity as compared to baseline visit. Another secondary outcome measured was to assess the Adverse Event associated with the treatment.
The results of this study demonstrate that the Ayurvedic Dant Manjan had a better efficacy profile, for the treatment of dental health problems such as gingivitis with bleeding gums, dental plaque, teeth stains, bad breath, tooth sensitivity as demonstrated by reduction of Gingival Index, Plaque Index, Lobene Stain Indices, Bad breath and Tooth Sensitivity at end of the Study Treatment and is safe and well tolerated.
|