| CTRI Number |
CTRI/2019/05/019306 [Registered on: 23/05/2019] Trial Registered Prospectively |
| Last Modified On: |
19/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [remineralizing tooth pastes] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical research to compare the remineralising effects of two commercially available pastes. |
|
Scientific Title of Study
|
Comparative evaluation of remineralization efficacy Nanohydroxyapatite and Bioactive glass on demineralized enamel – An in situ study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Yogha Padhma |
| Designation |
Post graduate student |
| Affiliation |
Adhiparasakthi Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district, Tamilnadu
na
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
7708722632 |
| Fax |
|
| Email |
yoghapadhma23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Srinivasan |
| Designation |
Reader |
| Affiliation |
Adhiparasakthi Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district, Tamilnadu
na
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9840479056 |
| Fax |
|
| Email |
srinistatsolutions@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Yogha Padhma |
| Designation |
Post graduate student |
| Affiliation |
Adhiparasakthi Dental College |
| Address |
Department of Conservative Dentistry and Endodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district, Tamilnadu
na
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
7708722632 |
| Fax |
|
| Email |
yoghapadhma23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr A Yogha Padhma
Post graduate,
Department of Conservative Dentistry and Endodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district,
Tamilnadu - 603319 |
|
|
Primary Sponsor
|
| Name |
Dr A Yogha Padhma |
| Address |
Post graduate student,
Second year,
Department of Conservative Dentistry and Endodontics, Adhiparasakthi Dental College and Hospital, Melmaruvathur, Kancheepuram district, Tamilnadu - 603319 |
| Type of Sponsor |
Other [self] |
|
|
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 A Yogha Padhma |
Adhiparasakthi dental college and hospital, Melmaruvathur |
Depatment of Conservative dentistry and Endodontics,Adhiparasakthi dental college, Melmaruvathur
Kancheepuram
TAMIL NADU |
7708722632
yoghapadhma23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND INSTITUTIONAL ETHICAL COMMITTEE OF ADHIPARASAKTHI DENTAL COLLEGE, MELMARUVATHUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy subjects without any active caries or periodontal diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bioactive glass |
A commercially available Paste containing Bioactive glass and fluoride applied on the surface of enamel slab twice daily. Duration: 3 minutes for each application.(Total Duration of therapy 7 days)
Route of Administration: Topical (paste) |
| Intervention |
Nanohydroxyapatite paste |
A commercially available Paste containing nano sized hydroxyapatite applied on the surface of enamel slab twice daily. Duration: 3 minutes for each application.(Total Duration of therapy 7 days)
Route of Administration: Topical (paste) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Participants with good oral hygiene, Participants with a salivary pH ranging between 6.8 – 7.2,
Participants with salivary flow above 1.0ml/min
Presence of atleast 22 natural teeth with no caries activity or periodontal disease.
|
|
| ExclusionCriteria |
| Details |
Participants with poor oral hygiene
Participants with very high caries activity
Participants with less than 22 teeth
Participants on antimicrobial or any other treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vicker’s microhardness values |
7 days after remineralization |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/05/2019 |
| Date of Study Completion (India) |
08/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="8" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Remineralization of enamel subsurface lesions in situ by sugarâ€free lozenges containing casein phosphopeptideamorphous calcium phosphate
F. Cai P. Shen MV Morgan EC Reynolds, March 2008
2. In Situ Caries Models
D.T. Zero, 1995 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an in-situ study comparing the
efficacy of biomimetic (nanohydroxapatite) and non biomimetic remineralizing
agents (bioactive glass) on demineralized enamel slabs obtained from extracted
human third molar teeth (cleaned and autoclaved).
In-Situ
study design: The
remineralization phase will take place in the oral cavity of healthy volunteers
under the influence of saliva.
Six healthy adult
volunteers (post graduate dental students) will take part in a 7 days in-situ study
after giving consent. They will wear
acrylic palatal appliances, with each appliance containing two rows of three demineralized
enamel slabs. One row slabs will be treated using biomimetic remineralization
system (Nanohydroxyapatite - Group I) and the other row slabs will receive
non-biomimetic remineralization systems (Bioactive glass - Group II) for 7 days. A part of
the enamel slab will serve as its own control (Baseline and demineralization).
After the completion of remineralization cycle, Vickers microhardness values will be calculated. |