Clinical trial NCT06119126: Two Preventive Measures on Caries Progression in Mixed Dentition Patients.
Official title: Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentist's Role
Keywords: SDF
Diode Laser
Pits and fissure sealants
primary molars
permanent molars
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of molars with arrested initial decay
timeFrame: 1 year follow up
Secondary outcomes:
measure: Number of molars with completely retained f pits and fissure sealants
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry British University
Study officials:
affiliation: Head of Department
name: Noha Kabil, Professor
role: STUDY_DIRECTOR
affiliation: Faculty Council Member
name: Basma Gamal, Lecturer
role: STUDY_DIRECTOR
References: