Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

• Sponsor: King Abdulaziz University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04560985
• Collaborator: (none)
• Enrollment: 42
• Arms: 2
• Anticipated Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries	Other: Hydrophilic fissure sealant; Other: Hydrophobic fissure sealant	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 3 months]

2. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 6 months]

3. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 12 months]

4. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 18 months]

5. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 24 months]

6. Sealant retention scoring using Color, Coverage and Caries (CCC) system [At 36 months]

Secondary Outcome Measures

1. Caries scoring using Color, Coverage and Caries (CCC) system [At 3 months]

2. Caries scoring using Color, Coverage and Caries (CCC) system [At 6 months]

3. Caries scoring using Color, Coverage and Caries (CCC) system [At 12 months]

4. Caries scoring using Color, Coverage and Caries (CCC) system [At 18 months]

5. Caries scoring using Color, Coverage and Caries (CCC) system [At 24 months]

6. Caries scoring using Color, Coverage and Caries (CCC) system [At 36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• King Abdulaziz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hussein A. Alharthy, Postgraduate student, King Abdulaziz University
• ClinicalTrials.gov Identifier: NCT04560985
• Other Study ID Numbers: 29-04-20
• First Posted: Sep 23, 2020
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 23, 2020