Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

Study Overview
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Brief Summary
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To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.

Official Title
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Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial

Conditions
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Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries

Intervention / Treatment
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* Other: Hydrophilic fissure sealant
* Other: Hydrophobic fissure sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with good health and without any systematic diseases history which may interfere with their oral hygiene. Children ranging in age from 6 to 9 years. Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II). Uncooperative children with definitely negative or negative behavioral ratings according to the Frankl behavior classification scale. Informed consent to the child's participation in the study signed by one of his/her parents/guardian. No children will be excluded on the basis of gender, race, social or economic status Exclusion Criteria: Children with systemic diseases. Children with oral habits affecting occlusion. Children with any physical or mental disorders. Children with cavitated, defected, missed or restored contralateral tooth. Children with history of allergy to resin or latex. Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects. Not approving to sign the consent.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrophilic sealant<br>UltraSeal XT hydro™ sealant ® | Other: Hydrophilic fissure sealant<br>* Hydrophilic fissure sealant on first molars<br>|
| Active Comparator: Hydrophobic sealant<br>Helioseal-F Sealant ® | Other: Hydrophobic fissure sealant<br>* Hydrophobic fissure sealant on first molars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 3 months | 
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 6 months | 
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 12 months | 
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 18 months | 
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 24 months | 
| Sealant retention scoring using Color, Coverage and Caries (CCC) system |  | At 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 3 months | 
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 6 months | 
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 12 months | 
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 18 months | 
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 24 months | 
| Caries scoring using Color, Coverage and Caries (CCC) system |  | At 36 months |