Remineralization Effect of Eggshell Powder on Post-orthod... | NCT03963791

Studies
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP

NCT03963791

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 28, 2019Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Dental Caries

Interventions

Eggshell powder gel
CPP-ACP crème

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

May 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 5, 2019Estimated

Primary Completion Date

Apr 5, 2020Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

May 15, 2019

First Submission Date that Met QC Criteria

May 22, 2019

First Posted Date

May 28, 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

May 22, 2019

Last Update Posted Date

May 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic 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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eggshell powder gel	Experimental	prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.	Other: Eggshell powder gel Other: CPP-ACP crème
CPP-ACP crème	Active Comparator	CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.	Other: Eggshell powder gel Other: CPP-ACP crème

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eggshell powder gel	Other	Eggshell powder gel produced from chicken eggs.	CPP-ACP crème Eggshell powder gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
white spot lesion progression.	The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).	6 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A patient who has just completed a comprehensive orthodontic treatment.
Presence of at least one WSL, DIAGNOdent score (0-20).
Age range between 13 and 35years.

Exclusion Criteria:

Patients are unable to return for recall appointments.
High caries risk.
Have plaque accumulation and a periodontal problem
In progress treatment of chronic disease.
Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

35 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
Cairo univercity		Cairo		002	Egypt	Mohammad Sarhan, BDS

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001688	Biological Products

Ancestor Terms

ID	Term
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided