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

Phase 2

• Conditions: White Spot Lesion
• Interventions: Drug: Cpp-Acp; Other: Pearl powder

• Registration Number: NCT03976583
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-07
• Study Start: 2019-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cpp-acp	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.
Pearl powder	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Digital photographic image analysis	12 months	Computerised software to analyse the change in the lesion