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Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

Sponsor
British University In Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT06119126
Collaborator
(none)
23
Enrollment
1
Location
4
Arms
40
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SDF1
  • Device: Diode Laser
  • Drug: Pit Fissure Sealant
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Diode laser application only

Device: Diode Laser
Irradiating Enamel by Diode laser
Other Names:
  • Class 4 dental laser

    		•
    Experimental: Group B

    SDF application only

    Drug: SDF1
    Topical SDF application
    Other Names:
  • silver diamine fluoride

    		•
    Experimental: Group C

    Diode laser application followed by pits and fissure sealant.

    Device: Diode Laser
    Irradiating Enamel by Diode laser
    Other Names:
  • Class 4 dental laser

    • Drug: Pit Fissure Sealant
    Sealing occlusal pits and fissures
    Other Names:
  • PFS

    		•
    Experimental: Group D

    SDF application followed by pits and fissure sealant.

    Drug: SDF1
    Topical SDF application
    Other Names:
  • silver diamine fluoride

    • Drug: Pit Fissure Sealant
    Sealing occlusal pits and fissures
    Other Names:
  • PFS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of molars with arrested initial decay [1 year follow up]

      ICDAS II Score system

    Secondary Outcome Measures

    1. Number of molars with completely retained f pits and fissure sealants [1 year follow up]

      Simonsen's Criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry British University Cairo Egypt

    Sponsors and Collaborators

    • British University In Egypt

    Investigators

    • Study Director: Noha Kabil, Professor, Head of Department
    • Study Director: Basma Gamal, Lecturer, Faculty Council Member

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Islam el guindy, Assistant Lecturer in Pediatric Dentistry, British University In Egypt
    ClinicalTrials.gov Identifier:
    NCT06119126
    Other Study ID Numbers:
    • PED 20-3D
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Islam el guindy, Assistant Lecturer in Pediatric Dentistry, British University In Egypt
    SDF
    Diode Laser
    Pits and fissure sealants
    primary molars
    permanent molars
    Additional relevant MeSH terms:
    Fluorides

    Study Results

    No Results Posted as of Nov 7, 2023