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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03963791
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
7.9
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Eggshell powder gel
  • Other: CPP-ACP crème
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.
Anticipated Study Start Date :
Oct 5, 2019
Anticipated Primary Completion Date :
Apr 5, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. white spot lesion progression. [6 months.]

      The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo univercity Cairo Egypt 002

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad A Sarhan, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03963791
    Other Study ID Numbers:
    • Oper_607
    First Posted:
    May 28, 2019
    Last Update Posted:
    May 28, 2019
    Last Verified:
    May 1, 2019
    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
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of May 28, 2019