Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

NCT ID: NCT04560985

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-01-01

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hydrophilic sealant

UltraSeal XT hydro™ sealant ®

Group Type EXPERIMENTAL

Hydrophilic fissure sealant

Intervention Type OTHER

Hydrophilic fissure sealant on first molars

Hydrophobic sealant

Helioseal-F Sealant ®

Group Type ACTIVE_COMPARATOR

Hydrophobic fissure sealant

Intervention Type OTHER

Hydrophobic fissure sealant on first molars

Interventions

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Hydrophilic fissure sealant

Hydrophilic fissure sealant on first molars

Intervention Type OTHER

Hydrophobic fissure sealant

Hydrophobic fissure sealant on first molars

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Hussein A. Alharthy

Postgraduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hussein Alharthy

Role: CONTACT

+966 50 038 2288

Other Identifiers

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29-04-20

Identifier Type: -

Identifier Source: org_study_id

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