| CTRI Number |
CTRI/2019/08/020737 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Retention of two Pit and Fissure sealants which are effective in presence of water and effective in absence of water in Permanent First Molar Teeth after 3, 6, and 9 months |
|
Scientific Title of Study
|
Comparative Evaluation of Retention of Hydrophilic and Hydrophobic Pit and Fissure Sealants in Permanent First Molars at 3, 6, and 9 months: An in-vivo study |
| Trial Acronym |
RHHPFS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
OMA GYATI |
| Designation |
MDS |
| Affiliation |
Maharishi Markandeshwar College of Dental Science and Research |
| Address |
Room no. 4,
Department of Pediatric and Preventive Dentistry,
Maharishi Markandeshwar College of Dental Science and Research
Ambala
HARYANA
133207
India |
| Phone |
8920973655 |
| Fax |
|
| Email |
gyatioma123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mansi Jain |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar College of Dental Science and Research |
| Address |
Room no. 4,
Department of Pediatric and preventive Dentistry
Maharishi Markandeshwar College of Dental Science and Research, Mullana
Ambala
HARYANA
133207
India |
| Phone |
9882600156 |
| Fax |
|
| Email |
mansijainsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Oma Gyati |
| Designation |
MDS |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Room no. 4,
Department of Pediatric and Preventive Dentistry,
Maharishi Markandeshwar College of Dental Science and Research,
Mullana
Ambala
HARYANA
133207
India |
| Phone |
8920973655 |
| Fax |
|
| Email |
gyatioma123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar College of Dental Science and Research, Mullana |
|
|
Primary Sponsor
|
| Name |
Oma Gyati |
| Address |
Maharishi Markandeshwar College Of Dental Science and Research, Maharishi Markandeshwar Deemed To Be University,
Mullana, Ambala, 133207, Haryana |
| 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 |
| Oma Gyati |
Maharishi Markandeshwar College of Dental Science and Research |
Room no. 4,
Department of Pediatric and Preventive Dentistry,
Maharishi Markandeshwar College of Dental Science and Research
Ambala
HARYANA |
08920973655
gyatioma123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EXPERIMENTAL |
Comparative evaluation of retention and marginal integrity of hydrophilic and hydrophobic pit and fissure sealants in permanent first molars at 3, 6, and 9 months : An in-vivo study.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children ready to comply with the study protocol
2. Children in age group of 6 – 9 years
3. All fully-erupted non-carious permanent first molars
4. Children with good general health
5. At least one pair of bilateral maxillary or mandibular caries free permanent first molars.
6. No history of any preventive dental treatment from last 6 months on the respective teeth
7. Patient at high risk of developing caries as per American Academy of Pediatric Dentistry (AAPD) criteria.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised children
2. Children with hypoplastic teeth
3. Partially erupted permanent first molars
4. Uncooperative children
5. Children with carious molars |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hydrophilic pit and fissure sealants will show significantly higher retention rates and better marginal integrity as compared to Hydrophobic sealants after 9 months in permanent first molars.
|
9 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the retention rates and marginal integrity of Hydrophilic and Hydrophobic pit and fissure sealants in permanent first molars at 3, 6, and 9 months.
To evaluate the caries incidence after application of pit and fissure sealants at 3, 6, and 9 months.
|
16-05-2020 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2019 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This was a Randomised Controlled Parallel study to compare and evaluate the retention rate and marginal integrity of Hydrophilic and Hydrophobic pit and fissure sealant and evaluate new caries incidence after application of sealants on permanent first molars at 3, 6, and 9 months. The study was carried out among 6 to 9 years children, with sample size- 80 which was divided into two groups of 40 teeth each. The samples were tabulated. The Experimental hypothesis was proved that the Hydrophilic pit and fissure sealants showed significantly higher retention rates and better marginal integrity as compared to Hydrophobic sealants after 9 months in permanent first molars. |