| CTRI Number |
CTRI/2024/10/075519 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Retention of Hydrophobic and Hydrophilic Pit and Fissure Sealants on Permanent Molars of Children between 6-14 years. |
|
Scientific Title of Study
|
Comparative Evaluation of Retention of Moisture Tolerant Pit and Fissure Sealant with Hydrophobic Sealant on Newly Erupted Permanent Molars – A Randomized Controlled Clinical 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 |
Sahin Firdous Ahmed |
| Designation |
Student |
| Affiliation |
I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida |
| Address |
Department of Paediatric and Preventive Dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida, Uttar Pradesh, 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971377284 |
| Fax |
|
| Email |
rosidasultana10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aayushi Sangal |
| Designation |
Assistant Professor |
| Affiliation |
I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida |
| Address |
Department of Paediatric and Preventive Dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida, Uttar Pradesh, 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9971377284 |
| Fax |
|
| Email |
aayushisangal.i7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahin Firdous Ahmed |
| Designation |
Student |
| Affiliation |
I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida |
| Address |
Department of Paediatric and Preventive Dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida, Uttar Pradesh, 201310
UTTAR PRADESH
201310
India |
| Phone |
9971377284 |
| Fax |
|
| Email |
rosidasultana10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatric And Preventive Dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida, Uttar Pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
Institute ITS Dental College and Research Centre |
| Address |
Department of Paediatric And Preventive Dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3 ,Greater Noida, Uttar Pradesh, 201310 |
| 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 Sahin Firdous |
I.T.S Dental College, Hospital and Research Centre |
Department of paediatric dentistry, Room No 9, I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida, 201310
Gautam Buddha Nagar
UTTAR PRADESH |
9971377284
rosidasultana10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental College, Hospital And Research Centre, Institutional Ethics Committee |
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 |
Prevent Denpro Pit and Fissure Sealant |
In Group B, teeth will be sealed with Prevest Denpro Sealant (Hydrophobic Sealant) following the manufacturer’s instructions. The occlusal surface will be dried using compressed air, followed by acid etching with 37 percent phosphoric acid gel for 20 s (Total Etch, Ivoclar-Vivadent, Schaan, Liechtenstein). Then, teeth will be rinsed with water for approximately 30 s and thoroughly air dried to reveal a white frosty surface. Sealant will be applied to the pits and fissures with a small applicator tip attached to the syringe. The sealant will be light-cured for 20 s using a visible light-curing unit. Follow up will be done at 3 months. 6 months and 12 months.
|
| Intervention |
Ultraseal XT Hydro pit and fissure sealant |
In Group A, teeth will be sealed with Ultraseal XT Hydro Sealant (Hydrophilic Sealant) following the manufacturer’s instructions. The occlusal surface will be dried using compressed air, followed by acid etching with 37 percent phosphoric acid gel for 20 s (Total Etch, Ivoclar-Vivadent, Schaan, Liechtenstein). Then, teeth will be rinsed with water for approximately 30 s and dried using cotton to reveal a moist glossy surface. Sealant will be applied to the pits and fissures with a small applicator tip attached to the syringe. The sealant will be light-cured for 20 s using a visible light-curing unit.
Follow up will be done at 3 months. 6 months and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Cooperative children between 6-14 years
2. Healthy patients with no history of previous systematic diseases that can affect their oral health (ASA I, II)
3. At least two fully erupted permanent molars (one on each side: right and left)
4. Permanent molars’ occlusal surfaces show scores of 0 or 1 according to the International Caries Detection and Assessment System II (ICDAS II)
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative children
2. Parents or guardians from whom consent cannot be obtained
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Ultraseal XT Hydro is expected to show superiority over the hydrophobic sealant in terms of sealant retention and caries inhibition when evaluated over 3, 6 and 12 months. |
At baseline, 3 months, 6 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sealant retention, evidence of new caries |
3months, 6months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 03-01-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pit and fissure sealants play a crucial role in preventing newly erupted molars from getting cariously involved. Since sealants bond micro mechanically to the tooth surface, therefore sealant adhesion is drastically influenced by the isolation achieved during the placement of these resin based materials. in such a scenario, novel hydrophilic sealants offer a great advantage since they are water miscible and thixotropic and can be placed with high clinical efficiency in paediatric patients where it is impossible to achieve complete moisture control. Hence the aim of this split mouth randomised controlled clinical trial is to compare and evaluate the retention of hydrophilic sealants with hydrophobic sealants when applied on newly erupted permanent molars. For this study, 34 participants between 6-14 years of age will be selected. Two teeth from each participant (one each on right and left side of the mouth) will be selected and randomly allocated into two groups : in group A the teeth will be sealed with Ultraseal XT Hydro (hydrophilic sealant), in group B the teeth will be sealed with Voco Fissurit F (Hydrophobic sealant). Evidence of new caries and sealant retention will be assessed at 3, 6 and 12 months. The results will be subjected to statistical analysis. |