Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions

NCT ID: NCT03976583

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-01

Brief Summary

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The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.

Detailed Description

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The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.

Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cpp-acp

MI paste Self-administration of the product by the patient once in the evening. A pea-size amount of the product should be applied per arch, using a dry finger or cotton pellet to distribute it evenly across all teeth and to work it into the interdental spaces. The product was then retained in the mouth for 1-3 min, and manipulated around the teeth using the tongue, before being expectorated and patient should not rinse it until 30 min.

Group Type ACTIVE_COMPARATOR

Cpp-Acp

Intervention Type DRUG

Remineralising agent

Pearl powder

Pure pearl powder in the form of gel Self-administration of the product should be used once daily (in the evening), after a 2 min manual tooth brushing. .Participants were explicitly instructed to apply the gel by his finger allover the teeth and not to rinse their mouths after application and not to eat or drink for at least 30 min.

Group Type EXPERIMENTAL

Pearl powder

Intervention Type OTHER

Natural product

Interventions

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Cpp-Acp

Remineralising agent

Intervention Type DRUG

Pearl powder

Natural product

Intervention Type OTHER

Other Intervention Names

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MI paste

Eligibility Criteria

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Inclusion Criteria

* Males or females.
* Age: 12-25 years old.
* Patients with good oral hygiene.
* Co-operative patients who show interest to participate in the study.

Exclusion Criteria

* Patients with bad oral hygiene.
* Lack of patient's approval and compliance.
* Presence of abnormal oral, medical, or mental condition.
* Patients who are allergic to milk products.
* Pregnant and lactating women.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shereen Assem El-Sherif

Assistant Lecturer - Conservative Department- Faculty of Dentistry - MSA University

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1081988

Identifier Type: -

Identifier Source: org_study_id

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