Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions

June 5, 2019 updated by: Ruba Alaa El Din Adel El Damarisy

Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.

to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: omar shaalan, lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • good oral hygiene
  • cooperative patient
  • completion of orthodontic therapy
  • presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

Exclusion Criteria:

  • bad oral hygiene
  • lack of patients compliance
  • allergy to milk products
  • pregnant or lactating women
  • presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
  • presence of periodontal pockets around maxillary anterior teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pearl powder
natural product, support bone and joint health
natural product, support bone and joint health
Active Comparator: CPP-ACP
product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces.
Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
Other Names:
  • tooth mousse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caries prevention in enamel white spot lesion
Time Frame: 12 months
caries prevention using laser fluorescence device
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ruba A El Damarisy, MDS, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2019

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

June 1, 2019

First Submitted That Met QC Criteria

June 1, 2019

First Posted (Actual)

June 4, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11090 (DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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