| CTRI Number |
CTRI/2017/10/010155 [Registered on: 23/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Triphala and chlorhexidine mouthwash use in reducing tooth decay and gum problems |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF THE EFFECT OF TRIPHALA AND CHLORHEXIDINE MOUTHWASH ON DENTAL PLAQUE, GINGIVAL INFLAMMATION AND MICROBIAL GROWTH IN 14-15 YEARS OLD SCHOOL CHILDREN - A RANDOMIZED CONTROLLED DOUBLE BLIND CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ketaki Bhor |
| Designation |
Post graduate student- 3rd year MDS |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
Pune
MAHARASHTRA
16
India |
| Phone |
8007786257 |
| Fax |
|
| Email |
ketaki.bhor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ketaki Bhor |
| Designation |
Post graduate student- 3rd year MDS |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
Pune
MAHARASHTRA
16
India |
| Phone |
8007786257 |
| Fax |
|
| Email |
ketaki.bhor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketaki Bhor |
| Designation |
Post graduate student- 3rd year MDS |
| Affiliation |
Sinhgad Dental College and Hospital |
| Address |
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
D-103 VRINDAVANAM SOCIETY
DEEP BANGLA CHOWK, MODEL COLONY, SHIVAJINAGAR
Pune
MAHARASHTRA
16
India |
| Phone |
8007786257 |
| Fax |
|
| Email |
ketaki.bhor@gmail.com |
|
|
Source of Monetary or Material Support
|
| the project was self funded, no monetary support was given |
|
|
Primary Sponsor
|
| Name |
Dr Ketaki Bhor |
| Address |
D-103 Vrindavanam society deep bangala chowk model colony shivajinagar |
| Type of Sponsor |
Other [Dental college and hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr ketaki bhor |
Dyandeep english medium school |
S.no 53/1/1, behind yashganga marble,opp old toll naka, wadgaon bk, 411041
Pune
MAHARASHTRA |
8007786257
ketaki.bhor@gmail.com |
| dr ketaki bhor |
jai hind english medium school |
1773, warje malwadi, pune 411058
Pune
MAHARASHTRA |
8007786257
ketaki.bhor@gmail.com |
| dr ketaki bhor |
royal roses english medium school |
sr.no 46, vidya nagar, wadgaon bk, pune 411041
Pune
MAHARASHTRA |
8007786257
ketaki.bhor@gmail.com |
| dr ketaki bhor |
utkarsha english medium school |
wadgaon bk, Pune 411041
Pune
MAHARASHTRA |
8007786257
ketaki.bhor@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| sinhgad dental college and hospital institutional ethics committee |
Approved |
| sinhgad dental college and hospital institutional ethics committee |
Approved |
| sinhgad dental college and hospital institutional ethics committee |
Approved |
| sinhgad dental college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD 10 - K05.1
Chronic gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.4% triphala mouthwash |
Phytoconcetrates triphal water based liquid extract with lot no Triphal/PCL1/Jul 14 used for treating, controlling and preventing dental plaque, gingivitis and dental plaque micro-organisms like streptococcus mutans, streptococcus sanguinis and lactobaccilli. Terminalia chebula, Terminialia belerica and
Emblica officinalis are the contents of triphala.T. chebula which acts as
anticaries agents strongly inhibits the sucrose or
glucan induced aggregations of S. mutans and strengthens the gums, prevents and treats several diseases of mouth such as dental caries, spongy and bleeding gums
gingivitis and stomatids. |
| Comparator Agent |
Eludril 0.12% chlorhexidine mouthwash |
Comercially available 0.12% chlorhexidine mouthwash used as 1:1 ratio with water for treating, controlling and preventing dental plaque, gingivitis and dental plaque micro-organisms like streptococcus mutans, streptococcus sanguinis and lactobaccilli. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Study participants of age group 14-15 years
2.Study participants with similar
i.socioeconomic status [Based on Kuppuswammy’s Socioeconomic status scale],
ii.oral hygiene methods
3.At least 20 intact natural teeth should be present.
4.Study participants with fair plaque score (Loe H 1967) and moderate gingivitis (Loe H and Silness J 1963) were selected.
5.Study participants willing to participate in the study and whose parents gave a written informed consent. |
|
| ExclusionCriteria |
| Details |
1.History of hypersensitivity to any product used in the study and other oral care products.
2.Unable to comply with the study appointment schedules.
3.Any oral soft tissue pathology.
4.Grossly decayed teeth and over-retained deciduous teeth.
5.Study participants having calculus
6.Suffering from non-plaque induced gingivitis or periodontitis.
7.Study participants with any systemic disorders that require the use of medications with side effects known to affect oral health.
8.Study participants using mouth rinse within the last 3 months.
9.Study participants under antimicrobial therapy at least 3 month prior to the study and using mouth rinses or dentifrices containing substances with anti-inflammatory properties.
10.Study participants with crowns or restorations on facial and lingual surfaces of teeth.
11.Study participants with malocclusion or fixed/ removable orthodontic appliances.
12.Study participants who are physically or mentally handicap.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of Triphala and Chlorhexidine mouthwash on dental plaque score and gingivitis score and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples.
3.To compare the effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples |
The demonstration regarding th use of mouthwash and the collection of plaque sample was done at 0 day, 30th day and at 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/07/2015 |
| Date of Study Completion (India) |
30/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
the study is not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized controlled double blind parallel three month clinical trial conducted among 72 school children of age group of 14-15 years, who are divided into two study groups: Group A- Triphala mouthwash (n=36) and Group B- Chlorhexidine mouthwash (n=36). The microbial counts were measured by conventional culture methods and plaque scores and gingival scores were recorded by using Plaque Index [Loe H (1967)] and Gingival Index [Loe H and Silness J (1963)] respectively at baseline, 30 days and 90 days interval. The primary outcome is to assess and compare the effect of 0.4% Triphala and 0.12% Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from dental plaque sample of 14-15 years old school children during 90 days supervised use. |