Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

Not Applicable

• Conditions: Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries
• Interventions: Other: Hydrophobic fissure sealant; Other: Hydrophilic fissure sealant

• Registration Number: NCT04560985
• Lead Sponsor: King Abdulaziz University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-05
• Study First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23
• Study Start: 2020-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Children with good health and without any systematic diseases history which may interfere with their oral hygiene.
2. Children ranging in age from 6 to 9 years.
3. 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).
4. Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
5. Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
6. No children will be excluded on the basis of gender, race, social or economic status

Exclusion Criteria

1. Children with systemic diseases.
2. Children with oral habits affecting occlusion.
3. Children with any physical or mental disorders.
4. Children with cavitated, defected, missed or restored contralateral tooth.
5. Children with history of allergy to resin or latex.
6. Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects.
7. Not approving to sign the consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrophobic sealant	Hydrophobic fissure sealant	Helioseal-F Sealant ®
Hydrophilic sealant	Hydrophilic fissure sealant	UltraSeal XT hydro™ sealant ®

Primary Outcome Measures

Name	Time	Method
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 36 months

Secondary Outcome Measures

Name	Time	Method
Caries scoring using Color, Coverage and Caries (CCC) system	At 36 months