| CTRI Number |
CTRI/2025/05/087346 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sealants application in posterior teeth under Magnification loupes in children |
|
Scientific Title of Study
|
Comparative Evaluation Of Retention Of Pit And Fissure Sealant Application Under Magnification Loupes (3.5x) V/S Naked Eye In Permanent First Molars - Randomized Control 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 Savari |
| Designation |
Post Graudate student |
| Affiliation |
SGT dental college Budhera Gurugram |
| Address |
Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India
Gurgaon
HARYANA
122505
India |
| Phone |
8398910051 |
| Fax |
|
| Email |
savari186@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalu Verma |
| Designation |
Professor |
| Affiliation |
SGT dental college Budhera Gurugram |
| Address |
Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India
Gurgaon
HARYANA
122505
India |
| Phone |
9871720820 |
| Fax |
|
| Email |
Shalu.verma@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savari |
| Designation |
Post Graudate student |
| Affiliation |
SGT dental college Budhera Gurugram |
| Address |
Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India
Gurgaon
HARYANA
122505
India |
| Phone |
8398910051 |
| Fax |
|
| Email |
savari186@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India |
|
|
Primary Sponsor
|
| Name |
SGT UniversityGurugramHaryana |
| Address |
Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Savari |
SGT dental college |
Room no. 202, Second floor,Department of Paediatric and Preventative Dentistry, Faculty of Dental Sciences,Shree Guru Gobind Singh Tricentenary University Gurugram Badli Road Chandu Budhera Gurugram 122505, Haryana , India
Gurgaon
HARYANA |
8398910051
savari186@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magification loupes(3.5x) and Naked eye |
Group A (Pit and Fissure sealant Application under Naked eyes)
For Application of Pit and Fissure sealant, surfaces of the permanent first molar will be cleaned with the help of toothbrush only to remove plaque and debris from enamel surfaces and fissures, moisture control is done with Rubber dam isolation (Coltene Waldent Inc Cuyamoga Falls Ohio,USA) and cotton roll. Etching of the surface is done with 37% orthophosphoric acid gel (Ammdent Frost Etchant), that is applied on the first permanent molar for 15 seconds and rinsed well with air-water spray. Drying of the surface is done with sterile cotton and air spray. The dry etched surfaces should appear as a matte, frosty white.Pit and fissure sealant (3M, Clinpro) is applied on the occlusal surface using the syringe needle tip. Applicating brush is use to evenly placed the sealant and excess is removed. Curing of the sealant is done for 10 seconds with LED curing light (BEE COOL PLUS, confident)
Group B( (Pit and Fissure sealant Application under Magnification loupes 3.5x)
For Application of Pit and Fissure sealant, surfaces of the permanent first molar will be cleaned with the help of toothbrush only to remove plaque and debris from enamel surfaces and fissures, moisture control is done with Rubber dam isolation (Coltene Waldent Inc Cuyamoga Falls Ohio,USA) and cotton roll. Etching of the surface is done with 37% orthophosphoric acid gel (Ammdent Frost Etchant), that is applied on the first permanent molar for 15 seconds and rinsed well with air-water spray. Drying of the surface is done with sterile cotton and air spray. The dry etched surfaces should appear as a matte, frosty white.Pit and fissure sealant (3M, Clinpro) is applied on the occlusal surface using the syringe needle tip. Applicating brush is use to evenly placed the sealant and excess is removed. Curing of the sealant is done for 10 seconds with LED curing light (BEE COOL PLUS, confident) |
| Intervention |
Pit And Fissure Sealant |
Group A (Pit and Fissure sealant Application under Naked eyes)
For Application of Pit and Fissure sealant, surfaces of the permanent first molar will be cleaned with the help of toothbrush only to remove plaque and debris from enamel surfaces and fissures, moisture control is done with Rubber dam isolation (Coltene Waldent Inc Cuyamoga Falls Ohio,USA) and cotton roll. Etching of the surface is done with 37% orthophosphoric acid gel (Ammdent Frost Etchant), that is applied on the first permanent molar for 15 seconds and rinsed well with air-water spray. Drying of the surface is done with sterile cotton and air spray. The dry etched surfaces should appear as a matte, frosty white.Pit and fissure sealant (3M, Clinpro) is applied on the occlusal surface using the syringe needle tip. Applicating brush is use to evenly placed the sealant and excess is removed. Curing of the sealant is done for 10 seconds with LED curing light (BEE COOL PLUS, confident)
Group B( (Pit and Fissure sealant Application under Magnification loupes 3.5x)
For Application of Pit and Fissure sealant, surfaces of the permanent first molar will be cleaned with the help of toothbrush only to remove plaque and debris from enamel surfaces and fissures, moisture control is done with Rubber dam isolation (Coltene Waldent Inc Cuyamoga Falls Ohio,USA) and cotton roll. Etching of the surface is done with 37% orthophosphoric acid gel (Ammdent Frost Etchant), that is applied on the first permanent molar for 15 seconds and rinsed well with air-water spray. Drying of the surface is done with sterile cotton and air spray. The dry etched surfaces should appear as a matte, frosty white.Pit and fissure sealant (3M, Clinpro) is applied on the occlusal surface using the syringe needle tip. Applicating brush is use to evenly placed the sealant and excess is removed. Curing of the sealant is done for 10 seconds with LED curing light (BEE COOL PLUS, confident)
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Children with age group between 6-8 years old, both male and female.
2.Patient with fully erupted First Permanent Molar.
3.Patient having intact Occlusal surface.
4.Children with International Caries Detection and Assessment System (ICDAS II) criteria score 0, 1 and 2. |
|
| ExclusionCriteria |
| Details |
1.Children with long standing systemic illness.
2.Teeth with developmental anamolies.
3.Uncooperative patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and evaluate the retention of sealant under Magnification loupes (3.5x) and naked eye at 1 week and 3 months. |
To assess and evaluate the retention of sealant under Magnification loupes (3.5x) and naked eye at 1 week and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the prevalence of types of fissure in permanent first molar by Pits & fissure morphology index (Symons in 1996) at baseline.
2. To evaluate & compare caries occurrence by ICDAS II criteria under Magnification loupes & Naked eye at baseline. |
1. To assess the prevalence of types of fissure in permanent first molar by Pits & fissure morphology index (Symons in 1996) at baseline.
2. To evaluate & compare caries occurrence by ICDAS II criteria under Magnification loupes & Naked eye at baseline. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
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
|
Permanent First Molars shows high prevalence of caries as early eruption into the oral cavity. Pit and fissure sealant forms a micro-mechanical bond, protective layer cutting the access of caries-producing bacteria from their source of nutrients.Magnification loupes enhances visualization, improve precision, promote better posture and help in reducing eye strain. The objective of this study is to assess and evaluate the retention of sealant done under Magnification loupes (3.5x) and Naked eye by using Modified Simonsen’ criteria at 1 week and 3 months.To assess the prevalence of types of fissure in permanent first molar by Pits and fissure morphology index (Symons in 1996). To evaluate and compare caries occurrence by ICDAS II criteria under Magnification loupes and Naked eye. A sample size of 60 teeth will be selected using randomized control trials ( Chit method ) and equally dividing into two groups. GROUP-A ( Pit And Fissure Sealant Application Done Under Naked Eye) and GROUP- B (Pit And Fissure Sealant Application Done Under Magnification Loupes 3.5x ). Follow up will be done at 1 week and 3 months using Modified Simonsen’s criteria. |