| CTRI Number |
CTRI/2014/11/005165 [Registered on: 03/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
06/11/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a herbal toothpaste in comparison with a triclosan containing toothpaste among dental students. |
|
Scientific Title of Study
|
Evaluation of the clinical efficacy of a Herbal Toothpaste in comparison with a Triclosan containing Toothpaste in a population of dental college students – A Double-Blind Randomized Controlled Trial |
| Trial Acronym |
HTTT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Shah |
| Designation |
PG student - Dept of periodontology |
| Affiliation |
TPCT’s Terna Dental College |
| Address |
TPCT’s Terna Dental College
Sector 22
Nerul
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820477903 |
| Fax |
|
| Email |
drsrishtis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipika Mitra |
| Designation |
Professor - Dept of periodontology |
| Affiliation |
TPCT’s Terna Dental College |
| Address |
TPCT’s Terna Dental College
Sector 22
Nerul
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti Shah |
| Designation |
PG student - Dept of periodontology |
| Affiliation |
TPCT’s Terna Dental College |
| Address |
TPCT’s Terna Dental College
Sector 22
Nerul
Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9820477903 |
| Fax |
|
| Email |
drsrishtis@gmail.com |
|
|
Source of Monetary or Material Support
|
| TPCTs Terna Dental College
Sector 22
Nerul |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Dental College |
| Address |
TPCTs Terna Dental College
Sector 22
Nerul
Navi Mumbai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Srishti Shah |
TPCT Terna Dental College |
Department Of Periodontology, Room no 57,TPCT’s Terna Dental College,
Sector 22,
Nerul , Navi Mumbai
Thane
MAHARASHTRA |
9820477903
drsrishtis@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Ethics-Commitee Terna Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Generalised marginal gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colgate total toothpaste |
Triclosan-based toothpaste
To be Used with a toothbrush, twice a day, using modified bass method of brushing
total duration of use - 4 weeks |
| Intervention |
Parodontax toothpaste |
Herbal-based toothpaste
To be Used with a toothbrush, twice a day, using modified bass method of brushing.
total duration of use - 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
healthy dentition having at least 25-28 natural teeth.
medically fit
none were undergoing antibiotic or anti-inflammatory therapy
had undergone such therapy in the previous six months.
Female subjects were neither pregnant nor taking any contraceptive pills. |
|
| ExclusionCriteria |
| Details |
gross oral pathology
orthodontic treatment
extensive restirations |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
plaque index
gingival index |
Baseline,
after 1 week
after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compliance assessed on returning the toothpaste |
after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background - The aim of the present study was to compare the effects of two commercially available toothpastes, one containing herbal ingredients and other containing triclosan, on plaque and gingivitis in a population of dental college students. Materials and method - A total of hundred volunteers participated in the study, who were randomly divided into 2 groups, consisting of 50 subjects each (n=50). Each group was assigned the test (herbal) and the control toothpaste (triclosan containing). Plaque and gingival index were measured at baseline, 1 week after scaling and 4 weeks after scaling and the values were subjected to statistical analysis. |