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

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

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.

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: Cpp-Acp; Other: Pearl powder

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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical index used for visual evaluation of white spot lesions	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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital photographic image analysis	Computerised software to analyse the change in the lesion	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (ACTUAL): June 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1081988

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No