The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303767
• Other study ID #: 00010556-IORG0008839
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2020
• Source: Alexandria University
• Contact: Mohamed A. Bayoumi, MSc
• Phone: 0122273853
• Email: mohamed.bayoumi[@]pua.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: February 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Drug:
• Casein phosphopeptide amorphous calcium phosphate
varnish containing calcium and phospate ions which act as a source for tooth remineralization

Procedure:
• Atraumatic restorative treatment
excavation of dental caries and restoring with light cured Glass Ionomer Restoration

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	clinical criteria and ART success criteria will be assessed	12 months
Other	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.	radiographic success of the teeth and radiographic density measures will be assessed	12 months
Other	Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.	polarized light microscope and scanning electron microscope will be used to describe the repaired dentine and the bacterial load	throughout the 12 months
Primary	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