Two Preventive Measures on Caries Progression in Mixed Dentition Patients.
NCT ID: NCT06119126
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2020-06-01
2023-10-01
Brief Summary
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Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
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Detailed Description
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Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Measured by Simonson's criteria over 1 year follow up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group A
Diode laser application only
Diode Laser
Irradiating Enamel by Diode laser
Group B
SDF application only
SDF1
Topical SDF application
Group C
Diode laser application followed by pits and fissure sealant.
Diode Laser
Irradiating Enamel by Diode laser
Pit Fissure Sealant
Sealing occlusal pits and fissures
Group D
SDF application followed by pits and fissure sealant.
SDF1
Topical SDF application
Pit Fissure Sealant
Sealing occlusal pits and fissures
Interventions
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SDF1
Topical SDF application
Diode Laser
Irradiating Enamel by Diode laser
Pit Fissure Sealant
Sealing occlusal pits and fissures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
.Patients categorized as moderate to high caries risk (deft index \>1) showing more than 1 new carious lesions or restorations in the last 36 months according to "ADA Caries Risk Assessment Form (Age \>6)" .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group.
.The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants.
.According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included.
Exclusion Criteria
.Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.
.Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits \& fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.
.Patients \& parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.
6 Years
9 Years
ALL
Yes
Sponsors
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British University In Egypt
OTHER
Responsible Party
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Islam el guindy
Assistant Lecturer in Pediatric Dentistry
Principal Investigators
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Noha Kabil, Professor
Role: STUDY_DIRECTOR
Head of Department
Basma Gamal, Lecturer
Role: STUDY_DIRECTOR
Faculty Council Member
Locations
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Faculty of Dentistry British University
Cairo, , Egypt
Countries
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Other Identifiers
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PED 20-3D
Identifier Type: -
Identifier Source: org_study_id
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