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

NCT03976583 | Unknown Phase 2

• 1 other identifier: 1081988
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Digital photographic image analysis

  12 months

Study Arms (2)

Cpp-acp

ACTIVE COMPARATOR

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

Pearl powder

EXPERIMENTAL

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

Interventions

Cpp-Acp DRUG

Remineralising agent

Also known as: MI paste

Cpp-acp

Pearl powder OTHER

Natural product

Pearl powder

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex; pearl powder

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer - Conservative Department- Faculty of Dentistry - MSA University

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: June 7, 2019

Record last verified: 2019-06