The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

NCT04303767 | Unknown Phase 2

• 1 other identifier: 00010556-IORG0008839
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Caries,Dental

Keywords

Casein Phosphopeptide Amorphous Calcium Phosphate; CPP-ACP; caries affected dentine; dentine repair; Atraumatic Restorative Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Other Outcomes (3)

• 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.

  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.

  12 months

• Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.

  throughout the 12 months

Study Arms (2)

Test (ART + CPP-ACP)

EXPERIMENTAL

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; Procedure: Atraumatic restorative treatment

Control (ART)

ACTIVE COMPARATOR

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

Interventions

Casein phosphopeptide amorphous calcium phosphate DRUG

varnish containing calcium and phospate ions which act as a source for tooth remineralization

Also known as: MI varnish

Test (ART + CPP-ACP)

Atraumatic restorative treatment PROCEDURE

excavation of dental caries and restoring with light cured Glass Ionomer Restoration

Also known as: ART

Control (ART); Test (ART + CPP-ACP)

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex; Dental Atraumatic Restorative Treatment

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Mohamed A. Bayoumi, MSc

  Pharos University in Alexandria

  PRINCIPAL INVESTIGATOR

• Azza G. Hanno, Professor

  Alexandria University

  STUDY DIRECTOR

• Karin M. Dowidar, Professor

  Alexandria University

  STUDY DIRECTOR

• Samia S. Omar, Professor

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Mohamed A. Bayoumi, MSc

CONTACT

0122273853; mohamed.bayoumi@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 11, 2020
• Study Start: March 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

EG (1)