Two Preventive Measures on Caries Progression in Mixed De... | NCT06119126

Studies
Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

NCT06119126

Sponsor

British University In Egypt

Status

Completed

Last Update Posted

Nov 7, 2023Actual

Enrollment

23Actual

Phase

Phase 2

Conditions

Dentist's Role

Interventions

SDF1
Diode Laser
Pit Fissure Sealant

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Oct 1, 2023Actual

First Submitted Date

Oct 29, 2023

First Submission Date that Met QC Criteria

Nov 3, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2023

Last Update Posted Date

Nov 7, 2023Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Laser Drug: Pit Fissure Sealant
Group D	Experimental	SDF application followed by pits and fissure sealant.	Drug: SDF1 Drug: Pit Fissure Sealant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SDF1	Drug	Topical SDF application	Group B Group D	silver diamine fluoride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of molars with arrested initial decay	ICDAS II Score system	1 year follow up

Secondary Outcomes

Measure	Description	Time Frame
Number of molars with completely retained f pits and fissure sealants	Simonsen's Criteria	1 year follow up

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Noha Kabil, Professor	Head of Department	Study Director
Basma Gamal, Lecturer	Faculty Council Member	Study Director

ID	Term
C024633	silver diamine fluoride
D054023	Lasers, Semiconductor
D010895	Pit and Fissure Sealants

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies