| CTRI Number |
CTRI/2018/05/013871 [Registered on: 14/05/2018] Trial Registered Prospectively |
| Last Modified On: |
11/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Application of two tooth decay preventive agents and its comparison among 7-10 Year Old School Children |
|
Scientific Title of Study
|
Clinical Evaluation Of Hydrophobic And Hydrophilic Pit And Fissure Sealants Among 7-10 Year Old School Children – An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indrapriyadharshini |
| Designation |
Post graduate student |
| Affiliation |
Ragas dental college and hospital affiliated to The Tamilnadu Dr MGR University |
| Address |
department of public health dentistry
Ragas dental college and hospital
2/102 East coast road
Uthandi
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9789617621 |
| Fax |
|
| Email |
indrapriyaphd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P D Madan Kumar |
| Designation |
Professor and Head |
| Affiliation |
Ragas Dental College and Hospital affiliated to The Tamilnadu Dr M G R Medical University |
| Address |
Department of Public Health Dentistry
Ragas Dental College and
Hospital
2/102 East Coast road Uthandi
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9841760306 |
| Fax |
|
| Email |
phdragas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P D Madan Kumar |
| Designation |
Professor and Head |
| Affiliation |
Ragas Dental College and Hospital affiliated to The Tamilnadu Dr M G R Medical University |
| Address |
Department of Public Health Dentistry
Ragas Dental College and
Hospital
2/102 East Coast road Uthandi
Chennai
Chennai
TAMIL NADU
600119
India |
| Phone |
9841760306 |
| Fax |
|
| Email |
phdragas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
G Indrapriyadharshini |
| Address |
Ragas Dental College and Hospital
2/102 East Coast road
Uthandi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Indrapriyadharshini G |
Government middle school |
Kannikoil street
Padalam
603308
Kancheepuram
TAMIL NADU |
9789617621
indrapriyaphd@gmail.com |
| Indrapriyadharshini G |
Hindu carnation school |
129 Hospital Rd
Madurantakam
603306
Kancheepuram
TAMIL NADU |
9789617621
indrapriyaphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Ragas Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
7-10 Year old school children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrophilic pit and fissure sealants |
It is the Moisture-Tolerant, resin-based Pit and Fissure Sealant (Embrace Wet Bond) that could effectively tolerate some degree of moisture when applied to the etched enamel surface without compromising the bond and without requiring a separate bonding agent |
| Comparator Agent |
hydrophobic pit and fissure sealants(Helioseal) |
Traditional pit and fissure sealants are hydrophobic and cannot be applied where there is moisture to ensure success. So isolation is mandatory for traditional sealants |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 7-10 years with fully erupted mandibular permanent first molars bilaterally.
2. Children scoring 0 or 1 according to ICDAS II criteria for detecting caries in their mandibular permanent first molars.
3. Children who have low risk of caries based on caries risk assessment tool.
4. Children who have caries free teeth presenting with deep pit and fissures.
5. Children whose parents do wish to give consent
|
|
| ExclusionCriteria |
| Details |
1.Children presenting with caries,pulpal involvement and restorations.
2.Children with any preventive measures carried out priorly.
3.Children who have enamel defects like amelogenesis imperfecta, enamel hypoplasia and
dental fluorosis.
4. Children who have space infections as a complication of the dentition.
5. Children undergoing orthodontic treatment.
6. Children who are under medications for any systemic illness altering the salivary composition and flow.
7. Children who are differentially abled.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of sealant retention Will be assessed using modified simonson’s criteria |
at baseline,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. To evaluate and compare additional factors such as colour match, marginal discolouration, secondary caries, anatomic form, marginal adaptation and surface texture of proximal sealants and adhesive systems months using United States Public Health Service - Modified Ryge Criteria for Direct Clinical Evaluation of Restorations proposed by Cvar and Ryge, 1980 |
at baseline,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A
split mouth design will be used in this study. These children will be randomly
divided into groups for either of the interventions. Group I (hydrophobic pit and fissure sealants)
will be used and group II (hydrophilic
pit and fissure sealants ) will be used.
Procedure for
hydrophobic pit and fissure sealants:
The
sealant will be placed as follows under proper isolation with rubber dam.
Occlusal surfaces of the teeth were etched with 37% phosphoric acid for 30
seconds and rinsed with water. The teeth were then dried with a mild oil-free
air stream to achieve a characteristic frosty white, chalky appearance of
enamel. Two coats of bonding agent were applied and light cured for 20 seconds
using visible light curing unit. Sealants were then applied and cured according
to the manufacturer’s instructions.
Procedure for
hydrophilic pit and fissure sealants:
Occlusal surfaces of the teeth were etched
with 37% phosphoric acid for 30 seconds and rinsed with water. With hydrophilic
pit and fissure sealants, the typical dull, frosted appearance of the etched
surface is not desired. Rather, the surface should be lightly dried and very
slightly moist with a glossy appearance. To accomplish this, a cotton pellet
was used to remove the excess moisture. No bonding agent was applied. The sealant
was applied as per manufacturer’s instructions followed by light curing for 40
seconds. |