Faculty of Dentistry British University
Cairo, Egypt
NCT Number: NCT06119126
Primary Objective:
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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Notify Me6 year–9 year
All sexes
Interventional
Phase 2
Cairo, Egypt
Primary Objective:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
.Children aged 6-9 years old.
.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
.Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.
.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.
Topical SDF application
Other names: silver diamine fluoride
Irradiating Enamel by Diode laser
Other names: Class 4 dental laser
Sealing occlusal pits and fissures
Other names: PFS
Time frame: 1 year follow up
ICDAS II Score system
Time frame: 1 year follow up
Simonsen's Criteria
British University In Egypt
Other
Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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