| CTRI Number |
CTRI/2022/01/039183 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To check the effectiveness of four different pit and fissures sealants in preventing the decay of teeth |
|
Scientific Title of Study
|
THE EVALUATION OF CLINICAL EFFICACY OF FOUR DIFFERENT PIT AND FISSURE SEALANT MODALITIES IN YOUNG PERMANENT MOLARS: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTI SOLANKI |
| Designation |
Junior resident |
| Affiliation |
KGMU |
| Address |
Fourth Floor, Department of paediatric and preventive dentistry ,New Dental building
King Georges medical university
Lucknow
UTTAR PRADESH
Fourth Floor, Department of paediatric and preventive dentistry, New Dental building
KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8979585728 |
| Fax |
|
| Email |
jyotisolanki899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Afroz Alam Ansari |
| Designation |
Professor and Guide |
| Affiliation |
King Georges medical university |
| Address |
Fourth Floor, Department of paediatric and preventive dentistry ,New Dental building
King Georges medical university
Lucknow
Fourth Floor, Department of paediatric and preventive dentistry ,New Dental building
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9335166662 |
| Fax |
|
| Email |
afrozalamansari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afroz Alam Ansari |
| Designation |
Professor and Guide |
| Affiliation |
King Georges medical university |
| Address |
Fourth Floor, Department of paediatric and preventive dentistry ,New Dental building
King Georges medical university
Lucknow
Fourth Floor, Department of paediatric and preventive dentistry ,New Dental building
KGMU
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9335166662 |
| Fax |
|
| Email |
afrozalamansari@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| king Georges medical university |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Solanki |
| Address |
Fourth floor Department of paediatric and preventive dentistry
New Dental building
Faculty of Dental Sciences
KGMU Lucknow |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Solanki |
King Georges Medical University |
Fourth floor Department of paediatric and preventive dentistry, Faculty of Dental Sciences, King Georges Medical University Lucknow 226003
Lucknow
UTTAR PRADESH |
8979585728
jyotisolanki899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P., Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I.Infiltrant resin ICON (DMG Dental materials, Hamburg, Germany)
III. Flowable nanohybrid composite Tetric N- Flow(Ivoclar – Vivadent).
IV.ICON and Tetric N-Flow Combination
|
GROUP I – ICON usage as per the manufacturer’s instructions involves the application of ICON Etch syringe (15 % hydrochloric acid),ICON ethanol dry and ICON – Infiltrant syringe.
GROUP III- For the application of flowable nanohybrid composite Tetric N-flow , after etching bonding agent will be applied on the etched tooth surface and cured as the per manufacturer guidelines. The rest of the procedure will remain same.
GROUP IV – The intended molars are treated with ICON resin infiltrant first and then followed by the application of flowable nanohybrid composite (Tetric N-Flow ) according to the steps illustrated above.
|
| Comparator Agent |
II.Moisture tolerant resin based sealant EmbraceTM WetbondTM (Pulpdent®) |
GROUP II- The occlusal surface will be etched with 37% phosphoric acid for 20 sec and rinsed thoroughly for 30 seconds. No bonding agent will be applied. Excess moisture will be removed from tooth surface using cotton pellets, but not desiccated to keep the tooth surface slightly moist, glossy or shiny. EmbraceTM wetbondTM sealant will be applied on the occlusal surface with small applicator tip attached to the syringe and light cured for 20 sec using same light cure unit. |
|
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Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Questionable pits and fissures in permanent mandibular or maxillary first molars with age of child ranging from 6 to 10 years.
2. Questionable pits and fissures in permanent mandibular or maxillary second molars with age of child ranging from 11 to 14 years.
3. Sound, Non cavitated grade 0,1 or 2 caries according to the international caries detection and assessment system ICDAS caries diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1.Children with hypoplastic permanent first/second molar.
2.Children with proximal caries in molars.
3.Occlusal carious lesions more than grade 2 according to ICDAS caries diagnostic criteria.
4.Teeth with developmental anomalies such as fluorosis etc.
5.Children with systemic disorders.
6.Previously placed sealants or restorations on molar teeth.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Change in clinical ICDAS scores for pit and fissure surfaces.
• Change in laser fluorescence scores (DIAGNOdent pen) for pit and fissure surfaces.
|
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Marginal integrity and Marginal discoloration of four different sealant modalities. |
At baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
07/01/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The current study is randomized, double blind ,split mouth trial which is designed to evaluate the clinical efficacy of resin infiltrant( ICON) and compare its efficacy in prevention of pits and fissures caries with other two commercially available fissure sealants and also to evaluate its efficacy in combination with flowable nanohybrid composite resin. The primary outcomes measures will be change in clinical ICDAS scores for pit and fissure surfaces and change in laser fluorescence scores (DIAGNOdent pen) for pit and fissure surfaces. The secondary outcomes measures will be marginal integrity and marginal discoloration of four different sealant groups. All outcomes shall be observed at baseline , three months and six months post intervention for each patient. Aim- To evaluate and compare clinical efficacy of four different pit and fissure modalities, viz, resin infiltrant (ICON),moisture tolerant fissure sealant(EW), flowable nanohybrid composites (Tetric N flow) and ICON and Tetric N flow combinational group in young permanent molars. Objectives -1. To evaluate and compare caries progression among four different pit and fissure sealant modalities using ICDAS diagnostic criteria. 2. To clinically assess and compare caries progression among four different pit and fissure modalities in using laser florescence (Diagnodent pen) during follow ups. 3. To evaluate and compare the marginal integrity and marginal integrity of four different pit and fissure sealant modalities. Study Groups - 1. infiltrant resin (ICON) 2. moisture tolerant resin based sealant (Embrace wetbond) 3. flowable nanohybrid composite(Tetric N flow) 4. ICON and Tetric N flow combination |