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
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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King Abdulaziz University |
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 |