Clinical trial NCT04560985: Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children
Official title: Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 3 months
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 6 months
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 12 months
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 18 months
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 24 months
measure: Sealant retention scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 36 months
Secondary outcomes:
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 3 months
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 6 months
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 12 months
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 18 months
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 24 months
measure: Caries scoring using Color, Coverage and Caries (CCC) system
timeFrame: At 36 months
Other outcomes:
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