Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04560985

Enrollment

Registered

2020-09-23

Start date

2020-10-01

Completion date

2024-01-01

Last updated

2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERHydrophilic fissure sealant

Hydrophilic fissure sealant on first molars

OTHERHydrophobic fissure sealant

Hydrophobic fissure sealant on first molars

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 9 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 3 months

Secondary

Measure	Time frame
Caries scoring using Color, Coverage and Caries (CCC) system	At 3 months

Contacts

Primary ContactHussein Alharthy

dr.hussein30@hotmail.com+966 50 038 2288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026