Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP (REEPP-WSC)

May 22, 2019 updated by: Mohammad A Sarhan, Cairo University

Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.

This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

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

13 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient who has just completed a comprehensive orthodontic treatment.
  • Presence of at least one WSL, DIAGNOdent score (0-20).
  • Age range between 13 and 35years.

Exclusion Criteria:

  • Patients are unable to return for recall appointments.
  • High caries risk.
  • Have plaque accumulation and a periodontal problem
  • In progress treatment of chronic disease.
  • Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
  • Presence of dentin caries, enamel hypoplasia or restorations on 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eggshell powder gel
prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
Other: Eggshell powder gel
Eggshell powder gel produced from chicken eggs.
Other Names:
  • Natural product
Other: CPP-ACP crème
A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.
Other Names:
  • MI Paste
Active Comparator: CPP-ACP crème
CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
Other: Eggshell powder gel
Eggshell powder gel produced from chicken eggs.
Other Names:
  • Natural product
Other: CPP-ACP crème
A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.
Other Names:
  • MI Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
white spot lesion progression.
Time Frame: 6 months.
The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).
6 months.

Collaborators and Investigators

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

Sponsor

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 5, 2019

Primary Completion (Anticipated)

April 5, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oper_607

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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