Bioactive Glass in the Treatment of Enamel White Spot Les... | NCT04401280

Studies
Bioactive Glass in the Treatment of Enamel White Spot Lesions

NCT04401280

Sponsor

Rania Salah

Status

Completed

Last Update Posted

Oct 19, 2021Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

White Spot Lesion of Tooth

Interventions

BiominF
Novamin
CPP-ACP

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

Oct 2021

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 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

May 15, 2020

First Submission Date that Met QC Criteria

May 20, 2020

First Posted Date

May 26, 2020Actual

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

Oct 11, 2021

Last Update Posted Date

Oct 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rania Salah, Clinical instructor and Principal investigator at conservative dentistry department, Alexandria UniversitySponsor-Investigator

Lead Sponsor

Rania SalahOTHER

Collaborators

Name	Class
Queen Mary University of London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BiominF®	Active Comparator	Test group	Drug: BiominF
Novamin®	Active Comparator	Test group	Drug: Novamin
CPP-ACP	Active Comparator	Control group	Drug: CPP-ACP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BiominF	Drug	in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached	BiominF®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in White spot lesions dimension	Quantified using computer-assisted analysis based on digital intraoral photographs	6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

Secondary Outcomes

Measure	Description	Time Frame
change in lesion fluorescence	evaluated using diode laser fluorescence device (Diagnodent)	6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
Absence of any active periodontal disease.
Written informed consent

Exclusion Criteria:

Known hypersensitivity/allergy to study products and/or materials used
teeth having deep carious lesions or extensive restorations
Unwillingness to be randomly assigned to 1 of the 3 treatment groups
Advanced periodontal disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

26 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry		Alexandria			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
C510984	NovaMin
C447032	casein phosphopeptide-amorphous calcium phosphate nanocomplex

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided