| CTRI Number |
CTRI/2024/09/074145 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical success rate of pit and fissure sealants in mandibular primary molars |
|
Scientific Title of Study
|
Comparison of clinical success rate of giomer based sealant and polymer based pit and fissures sealant in mandibular second primary molars-A Split mouth Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elanthendral Saravanan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental College |
| Address |
Clinic 28,Department of pediatric and preventive dentistry, Saveetha dental college and hospitals,velappanchavadi,chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
08190996644 |
| Fax |
|
| Email |
152211003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lavanya Govindaraju |
| Designation |
Reader |
| Affiliation |
Saveetha dental college |
| Address |
Saveetha dental college,Seneerkuppam,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9047605630 |
| Fax |
|
| Email |
glaavuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lavanya Govindaraju |
| Designation |
Reader |
| Affiliation |
Saveetha dental college |
| Address |
Saveetha dental college,Seneerkuppam,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9047605630 |
| Fax |
|
| Email |
glaavuu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals 162,Poonamalleee high road,Chennai 600077, India |
|
|
Primary Sponsor
|
| Name |
Elanthendral Saravanan |
| Address |
162,Poonamallee high road, Chennai 600077,India |
| 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 |
| Lavanya Govindaraju |
Saveetha dental college and hospitals |
clinic 28,Department of pediatric and preventive dentistry,Chennai
Chennai
TAMIL NADU |
9047605630
glaavuu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deep pits |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beautisealant |
Beautisealant is a tooth colored, fluoride recharging, pit and fissure sealant with a self-etching primer that speeds treatment time by eliminating the need for phosphoric acid etching. Using an advanced, self-etching primer, Beautisealant helps preserve healthy enamel that is easily demineralized with harsh acid-etchants, while still maintaining superior bond strength |
| Comparator Agent |
Clinpro 3M ESPE Sealant |
3M Clinpro Sealant is a light-cure, fluoride-releasing pit and fissure sealant with a unique patented color-change technology. This dental sealant is pink when applied to the tooth surface and then changes to white when exposed to light. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with no signs of occlusal caries (sound teeth)
Pair of contralateral mandibular second primary molars
|
|
| ExclusionCriteria |
| Details |
Teeth with caries
Teeth with developmental defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention |
3,6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marginal staining, Secondary Caries, Color match, Marginal adaptation, Postoperative sensitivity |
3,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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="0"
Months="9"
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
|
In this split - mouth study, we aimed to compare the clinical success rate of giomer based sealant and polymer based pit and fissure sealant in mandibular second primary molars. This study will assess the Application time of both sealant at first visit and Retention, marginal discoloration, secondary caries, color match, marginal adaptation, Postoperative sensitivity and these parameters are assessed at 3 months, 6 months and 9 months. The results of this will further help in preventing the risk of decay in children. |