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Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children

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ClinicalTrials.gov Identifier: NCT04560985
Recruitment Status : Not yet recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hussein A. Alharthy, King Abdulaziz University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : January 1, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 3 months ]
  2. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 6 months ]
  3. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 12 months ]
  4. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 18 months ]
  5. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 24 months ]
  6. Sealant retention scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 36 months ]

Secondary Outcome Measures :
  1. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 3 months ]
  2. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 6 months ]
  3. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 12 months ]
  4. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 18 months ]
  5. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 24 months ]
  6. Caries scoring using Color, Coverage and Caries (CCC) system [ Time Frame: At 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560985


Contacts
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Contact: Hussein Alharthy +966 50 038 2288 dr.hussein30@hotmail.com

Sponsors and Collaborators
King Abdulaziz University
More Information
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Responsible Party: Hussein A. Alharthy, Postgraduate student, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT04560985    
Other Study ID Numbers: 29-04-20
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No