Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

King Abdulaziz University

Status: Unknown

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

Treatments: Other: Hydrophilic fissure sealant; Other: Hydrophobic fissure sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT04560985

29-04-20

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Hydrophilic sealant

Experimental group

Description:

UltraSeal XT hydro™ sealant ®

Treatment:

Other: Hydrophilic fissure sealant

Hydrophobic sealant

Active Comparator group

Description:

Helioseal-F Sealant ®

Treatment:

Other: Hydrophobic fissure sealant