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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries
• Intervention / Treatment: Other: Hydrophilic fissure sealant; Other: Hydrophobic fissure sealant

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hussein Alharthy; Phone Number: +966 50 038 2288; Email: dr.hussein30@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrophilic sealant; UltraSeal XT hydro™ sealant ®	Other: Hydrophilic fissure sealant; Hydrophilic fissure sealant on first molars
Active Comparator: Hydrophobic sealant; Helioseal-F Sealant ®	Other: Hydrophobic fissure sealant; Hydrophobic fissure sealant on first molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 3 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 6 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 12 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 18 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 24 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system	At 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Caries scoring using Color, Coverage and Caries (CCC) system	At 3 months
Caries scoring using Color, Coverage and Caries (CCC) system	At 6 months
Caries scoring using Color, Coverage and Caries (CCC) system	At 12 months
Caries scoring using Color, Coverage and Caries (CCC) system	At 18 months
Caries scoring using Color, Coverage and Caries (CCC) system	At 24 months
Caries scoring using Color, Coverage and Caries (CCC) system	At 36 months

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 29-04-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No