The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

March 7, 2020 updated by: Hams Hamed Abdelrahman

The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)

Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients selected to participate in the study will be randomly assigned into 2 groups.

Group 1 (test): who will receive casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) + ART in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.

Group 2 (control): Who will receive ART only in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.

Study Type

Interventional

Enrollment (Anticipated)

132

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 Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Dentistry, Alexandria University

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

4 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy patients.
  2. Patients with an age range of 6-8 years old for clinical evaluation.
  3. Patients ranking definitely positive or positive on Frankl scale.
  4. Patients having at least 1 symptomless primary molar with caries extending to the dentine (International Caries Detection and Assessment System (ICDAS II) code 4, 5 & 6).
  5. The presence of the permanent successors when examined by periapical X-ray.

  6. Patients who will agree to participate in the study. For the ex-vivo sample

    1. Patients with an age range of 9-11 years old.
    2. The selected teeth should have more than half of their roots physiologically resorbed when examined by periapical X-ray.

Exclusion Criteria:

  1. Patients with special health care needs (physical, mental or medical).
  2. Primary molars that are mobile, ankylosed or have periapical pathology on initial examination clinically and radiographically.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test (ART + CPP-ACP)
In this group, teeth selected will receive intervention with CPP-ACP and restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART
Drug: Casein phosphopeptide amorphous calcium phosphate
varnish containing calcium and phospate ions which act as a source for tooth remineralization
Other Names:
  • MI varnish
Procedure: Atraumatic restorative treatment
excavation of dental caries and restoring with light cured Glass Ionomer Restoration
Other Names:
  • ART
Active Comparator: Control (ART)
in this group, teeth selected will receive restorations with light cured Glass Ionomer restorations after excavating the carious lesions preserving the caries affected dentine using the ART
Procedure: Atraumatic restorative treatment
excavation of dental caries and restoring with light cured Glass Ionomer Restoration
Other Names:
  • ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
Time Frame: 12 months
this is by evaluating the clinical and radiographic data and also by descriptive histological assessment
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate and compare the clinical outcome of Atraumatic Restorative Treatment with and without Casein Phosphopeptide Amorphous Calcium Phosphate varnish placed on caries affected dentine in primary molars to evaluate the restoration success or failure.
Time Frame: 12 months
clinical criteria and ART success criteria will be assessed
12 months
Assess the radiographic success of Atraumatic Restorative Treatment with and without CPP-ACP varnish placed on caries affected dentine in primary molars by measuring the grey value radiographically using Image J software.
Time Frame: 12 months
radiographic success of the teeth and radiographic density measures will be assessed
12 months
Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.
Time Frame: throughout the 12 months
polarized light microscope and scanning electron microscope will be used to describe the repaired dentine and the bacterial load
throughout the 12 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

Investigators

  • Principal Investigator: Mohamed A. Bayoumi, MSc, Pharos University in Alexandria
  • Study Director: Azza G. Hanno, Professor, Alexandria University
  • Study Director: Karin M. Dowidar, Professor, Alexandria University
  • Study Director: Samia S. Omar, Professor, Alexandria 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)

March 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 7, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010556-IORG0008839

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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