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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03976583

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
White Spot Lesion	Drug: Cpp-Acp Other: Pearl powder	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions (Randomized Controlled Trial)

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Cpp-Acp Remineralising agent Other Names: MI paste
Experimental: 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.	Other: Pearl powder Natural product

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Cpp-Acp

Remineralising agent

Other Names:

MI paste

Experimental: 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.

Other: Pearl powder

Natural product

Outcome Measures

Primary Outcome Measures

Clinical index used for visual evaluation of white spot lesions [12 months]
Scores(0-No visible colour change, 1-Slight white colour change, only visible after air-drying, 2-Slight colour change with certain marked white areas, 3-White consistent colour change, 4-Distinct white colour change)

Secondary Outcome Measures

Digital photographic image analysis [12 months]
Computerised software to analyse the change in the lesion

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shereen Assem El-Sherif, Assistant Lecturer - Conservative Department- Faculty of Dentistry - MSA University, Cairo University

ClinicalTrials.gov Identifier:

NCT03976583

Other Study ID Numbers:

1081988

First Posted:

Jun 6, 2019

Last Update Posted:

Jun 7, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 7, 2019