Caries Prevention Potential of Pearl Powder Versus CPP-AC... | NCT03973554

Studies
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions

NCT03973554

Sponsor

Ruba Alaa El Din Adel El Damarisy

Status

Unknown status

Last Update Posted

Jun 7, 2019Actual

Enrollment

58Estimated

Phase

Phase 2

Conditions

White Spot Lesion of Tooth

Interventions

pearl powder
CPP-ACP

Countries

Not provided

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2019Estimated

Primary Completion Date

Oct 30, 2020Estimated

Completion Date

Oct 30, 2021Estimated

First Submitted Date

Jun 1, 2019

First Submission Date that Met QC Criteria

Jun 1, 2019

First Posted Date

Jun 4, 2019Actual

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

Jun 5, 2019

Last Update Posted Date

Jun 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruba Alaa El Din Adel El Damarisy, principal investigator, Cairo UniversitySponsor-Investigator

Lead Sponsor

Ruba Alaa El Din Adel El DamarisyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

Detailed Description

The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

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

58Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pearl powder	Experimental	natural product, support bone and joint health	Other: pearl powder
CPP-ACP	Active Comparator	product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces.	Drug: CPP-ACP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pearl powder	Other	natural product, support bone and joint health	pearl powder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
caries prevention in enamel white spot lesion	caries prevention using laser fluorescence device	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good oral hygiene
cooperative patient
completion of orthodontic therapy
presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

Exclusion Criteria:

bad oral hygiene
lack of patients compliance
allergy to milk products
pregnant or lactating women
presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
presence of periodontal pockets around maxillary anterior teeth

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruba A El Damarisy, MDS	Contact	01222308685		eldamarisyruba@gmail.com
omar shaalan, lecturer	Contact

Overall Officials

Name	Affiliation	Role
Ruba A El Damarisy, MDS	Cairo University	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000719515	pearl powder
C447032	casein phosphopeptide-amorphous calcium phosphate nanocomplex

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided