| CTRI Number |
CTRI/2025/02/080519 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hydrophilic versus Hydrophobic Dental Sealants in preventing dental caries |
|
Scientific Title of Study
|
Comparative evaluation of Hydrophilic and Hydrophobic Dental Sealants in preventing dental caries among 6–12-year-old school children: A split mouth randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavna Sabbarwal |
| Designation |
Associate Professor |
| Affiliation |
Post graduate Institute of Dental Sciences, Pt BD Sharma University |
| Address |
Department of Public Health Dentistry, PGIDS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466857242 |
| Fax |
|
| Email |
bhavnasabbarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Sabbarwal |
| Designation |
Associate Professor |
| Affiliation |
Post graduate Institute of Dental Sciences, Pt BD Sharma University |
| Address |
Department of Public Health Dentistry, PGIDS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466857242 |
| Fax |
|
| Email |
bhavnasabbarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavna Sabbarwal |
| Designation |
Associate Professor |
| Affiliation |
Post graduate Institute of Dental Sciences, Pt BD Sharma University |
| Address |
Department of Public Health Dentistry, PGIDS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09466857242 |
| Fax |
|
| Email |
bhavnasabbarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India. Pin code- 124001 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavna Sabbarwal |
| Address |
Department of Public Health Dentistry, Postgraduate institute of Dental Sciences, Rohtak, Haryana, India- 124001 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 Bhavna Sabbarwal |
department of public health dentistry |
Room number 14, postgraduate institute of dental sciences, Rohtak, Haryana
Rohtak
HARYANA |
9466857242
bhavnasabbarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL AND HEALTH RESEARCH ETHICS COMMITTEE, PGIDS, ROHTAK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deep Pits and Fissure on occlusal surface of posterior molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrophillic sealant |
UltraSeal XT hydro hydrophilic pit and fissure sealant is a light-cured, radiopaque, fluoride-releasing composite sealant. It is stronger and more wear resistant because it is a 53%-filled resin and has less polymerization shrinkage than competitive products. |
| Comparator Agent |
Hydrophobic sealant |
Clinpro is an unfilled, bis-GMA-containing sealant. It is a visible light cure and fluoride-releasing pink sealant, which changes to white colour after polymerization. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Completely erupted first permanent molars with deep pits and fissures which are either caries free or exhibiting incipient non cavitated enamel lesion in the pit & fissure system and without any restoration on any of the tooth surface will be included in the study
|
|
| ExclusionCriteria |
| Details |
Children with hypoplastic first permanent molars or developmental anomalies will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| retention of pit and fissure sealants more than 50 percent fissure coverage |
at 1 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of caries risk through AAPD criteria |
at 1 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
28/02/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Pit and fissure caries are challenging to deal with as the area is neither self cleaning nor accessible to conventional methods of tooth cleaning. Hence we need a good preventive measure to avoid the onset of caries in first place. Pit and fissure sealants are one such option. Rationale: Conventional pit and fissure sealants are hydrophobic and cannot be applied where there are problems of moisture control. So isolation is mandatory for them. Hence hydrophilic sealants provide a hope to overcome the limitation. Objectives: To assess the effectiveness of hydrophilic vs hydrophobic dentals in preventing dental caries. Methods: It will be a split mouth randomized controlled trial among 6-14 year school children. One group will receive hydrophilic sealant and the other will receive hydrophobic one. Follow up will be done at 1, 6 and 18 months. Suitable descriptive and inferential statistics will be applied. Expected outcome: We are expecting better retention with hydrophilic sealant material compared to hydrobhobic but no difference in cariostatic effect and discoloration. So that hydrophilic material can be recommended for newly erupted teeth that were left unsealed due to problem of moisture control among children. |