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Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06119126
Enrollment
23
Registered
2023-11-07
Start date
2020-06-01
Completion date
2023-10-01
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentist's Role

Keywords

SDF, Diode Laser, Pits and fissure sealants, primary molars, permanent molars

Brief summary

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.

Detailed description

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.

Interventions

DRUGSDF1

Topical SDF application

DEVICEDiode Laser

Irradiating Enamel by Diode laser

Sealing occlusal pits and fissures

Sponsors

British University In Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of molars with arrested initial decay1 year follow upICDAS II Score system

Secondary

MeasureTime frameDescription
Number of molars with completely retained f pits and fissure sealants1 year follow upSimonsen's Criteria

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026