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

NCT ID: NCT03973554

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-10-30

Brief Summary

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

Detailed Description

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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.

Conditions

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White Spot Lesion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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pearl powder

natural product, support bone and joint health

Group Type EXPERIMENTAL

pearl powder

Intervention Type OTHER

natural product, support bone and joint health

CPP-ACP

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.

Group Type ACTIVE_COMPARATOR

CPP-ACP

Intervention Type DRUG

Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate

Interventions

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pearl powder

natural product, support bone and joint health

Intervention Type OTHER

CPP-ACP

Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate

Intervention Type DRUG

Other Intervention Names

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tooth mousse

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruba Alaa El Din Adel El Damarisy

OTHER

Sponsor Role lead

Responsible Party

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Ruba Alaa El Din Adel El Damarisy

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ruba A El Damarisy, MDS

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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Ruba A El Damarisy, MDS

Role: CONTACT

01222308685

omar shaalan, lecturer

Role: CONTACT

Other Identifiers

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11090

Identifier Type: -

Identifier Source: org_study_id

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