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The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Primary Purpose

Caries,Dental

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Casein phosphopeptide amorphous calcium phosphate
Atraumatic restorative treatment
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries,Dental focused on measuring Casein Phosphopeptide Amorphous Calcium Phosphate, CPP-ACP, caries affected dentine, dentine repair, Atraumatic Restorative Treatment

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test (ART + CPP-ACP)

Control (ART)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
this is by evaluating the clinical and radiographic data and also by descriptive histological assessment

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
March 7, 2020
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04303767
Brief Title
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
Official Title
The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental
Keywords
Casein Phosphopeptide Amorphous Calcium Phosphate, CPP-ACP, caries affected dentine, dentine repair, Atraumatic Restorative Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test (ART + CPP-ACP)
Arm Type
Experimental
Arm Description
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
Arm Title
Control (ART)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Casein phosphopeptide amorphous calcium phosphate
Other Intervention Name(s)
MI varnish
Intervention Description
varnish containing calcium and phospate ions which act as a source for tooth remineralization
Intervention Type
Procedure
Intervention Name(s)
Atraumatic restorative treatment
Other Intervention Name(s)
ART
Intervention Description
excavation of dental caries and restoring with light cured Glass Ionomer Restoration
Primary Outcome Measure Information:
Title
Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
Description
this is by evaluating the clinical and radiographic data and also by descriptive histological assessment
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
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.
Description
clinical criteria and ART success criteria will be assessed
Time Frame
12 months
Title
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.
Description
radiographic success of the teeth and radiographic density measures will be assessed
Time Frame
12 months
Title
Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.
Description
polarized light microscope and scanning electron microscope will be used to describe the repaired dentine and the bacterial load
Time Frame
throughout the 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy patients. Patients with an age range of 6-8 years old for clinical evaluation. Patients ranking definitely positive or positive on Frankl scale. 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). The presence of the permanent successors when examined by periapical X-ray. Patients who will agree to participate in the study. For the ex-vivo sample Patients with an age range of 9-11 years old. The selected teeth should have more than half of their roots physiologically resorbed when examined by periapical X-ray. Exclusion Criteria: Patients with special health care needs (physical, mental or medical). Primary molars that are mobile, ankylosed or have periapical pathology on initial examination clinically and radiographically.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Bayoumi, MSc
Phone
0122273853
Email
mohamed.bayoumi@pua.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. Bayoumi, MSc
Organizational Affiliation
Pharos University in Alexandria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azza G. Hanno, Professor
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karin M. Dowidar, Professor
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samia S. Omar, Professor
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

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