| CTRI Number |
CTRI/2024/05/066697 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate water resistant giomer based and water loving pit and fissure sealants ,inside mouth |
|
Scientific Title of Study
|
Clinical and comparative evaluation of hydrophobic giomer based and hydrophillic pit and fissure sealants -an in vivo study |
| Trial Acronym |
pit and fissure sealants |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ema Joy |
| Designation |
MDS student |
| Affiliation |
M.M college of dental sciences and research |
| Address |
Maharishi Markandeshwar college of dental sciences and Research ,Maharishi Markandeshwar Deemed to be University , Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
9894007282 |
| Fax |
|
| Email |
elma.joy11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Prinka Shahi |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research |
| Address |
Maharishi Markandeshwar College Of Dental Sciences and Research Maharishi Markandeshwar Deemed to be University, Mullana ,Ambala
Ambala
HARYANA
133207
India |
| Phone |
8146379910 |
| Fax |
|
| Email |
pshahi@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ema Joy |
| Designation |
MDS student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University)college of dental sciences and research |
| Address |
Maharishi Markandeshwar College of Dental Sciences and Research,Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
9894007282 |
| Fax |
|
| Email |
elma.joy11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharaishi Markandeshwar Deemed University, M.M college of dental sciences and research, 133203.Department of pediatric and preventive dentistry Room no. 4, Mullana, Ambala,India |
|
|
Primary Sponsor
|
| Name |
Dr Ema Joy |
| Address |
Maharishi Markandeshwar college of dental sciences and research Maharishi Markandeshwar Deemed to be University |
| Type of Sponsor |
Other [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 Ema Joy |
Maharishi Markandeshwar College of Dental Science and research |
MMCDSR ,Department of pediatric and preventive Dentistry room number 4 Mullana Ambala
Ambala
HARYANA |
8848671815
elma.joy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MM Institute of Medical Science and research, Mullana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
non cavitated first permanent molas |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrophillic Sealant |
In group 1 Hydrophillic sealant will be applied with and without bonding agent |
| Comparator Agent |
Hydrophobic sealant |
In group 2 Hydrophobic sealant will be applied with and without bonding agent |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Fully erupted non carious permanent molar
contralateral and ipsilateral molars
no history of any fluoride application from last 6 months of sealant application
children with high risk of caries
presents of bilateral maxillary and mandibular molars |
|
| ExclusionCriteria |
| Details |
Un-cooperative children
children of parents who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hydrophillic pit and fissure sealants will significantly show higher rate of retention ,marginal integrity and anatomic form as compared to hydrophobic pit and fissure sealants after 6 months on permanent molars |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hydrophillic and hydrophobic pit and fissure sealants will show same retention, marginal integrity and anatomic form after 6 months of follow up |
baseline |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
10/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To evaluate and compare the hydrophobic giomer based and hydrophillic (ultraseal XT hydro)pit and fissure sealants on permanent molars in 6-10 year old children to know the greater retention, marginal integrity,anatomic form and to assess the development of new carious lesions ..the sample size will be divided into two groups, in which one group receives hydrophobic sealants with and without bonding agent and the next group will be applied with hydrophillic sealant with and without bonding agent and will be evaluated for retention, marginal integrity and anatomic form. |