NCT06119126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

October 29, 2023

Last Update Submit

November 5, 2023

Conditions

Dentist's Role

Keywords

SDFDiode LaserPits and fissure sealantsprimary molarspermanent molars

Outcome Measures

Primary Outcomes (1)

  • Number of molars with arrested initial decay

    ICDAS II Score system

    1 year follow up

Secondary Outcomes (1)

  • Number of molars with completely retained f pits and fissure sealants

    1 year follow up

Study Arms (4)

Group A

EXPERIMENTAL

Diode laser application only

Device: Diode Laser

Group B

EXPERIMENTAL

SDF application only

Drug: SDF1

Group C

EXPERIMENTAL

Diode laser application followed by pits and fissure sealant.

Device: Diode LaserDrug: Pit Fissure Sealant

Group D

EXPERIMENTAL

SDF application followed by pits and fissure sealant.

Drug: SDF1Drug: Pit Fissure Sealant

Interventions

SDF1DRUG

Topical SDF application

Also known as: silver diamine fluoride
Group BGroup D
Diode LaserDEVICE

Irradiating Enamel by Diode laser

Also known as: Class 4 dental laser
Group AGroup C
Pit Fissure SealantDRUG

Sealing occlusal pits and fissures

Also known as: PFS
Group CGroup D

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry British University

Cairo, Egypt

Location

MeSH Terms

Interventions

silver diamine fluorideLasers, SemiconductorPit and Fissure Sealants

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Noha Kabil, Professor

    Head of Department

    STUDY DIRECTOR

  • Basma Gamal, Lecturer

    Faculty Council Member

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer in Pediatric Dentistry

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 7, 2023

Study Start

June 1, 2020

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)