Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04560985
• Other study ID #: 29-04-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2020
• Source: King Abdulaziz University
• Contact: Hussein Alharthy
• Phone: +966 50 038 2288
• Email: dr.hussein30[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Hydrophilic fissure sealant
Hydrophilic fissure sealant on first molars
• Hydrophobic fissure sealant
Hydrophobic fissure sealant on first molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 3 months
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 6 months
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 12 months
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 18 months
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 24 months
Primary	Sealant retention scoring using Color, Coverage and Caries (CCC) system		At 36 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 3 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 6 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 12 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 18 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 24 months
Secondary	Caries scoring using Color, Coverage and Caries (CCC) system		At 36 months