The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Phase 2

• Conditions: Caries,Dental
• Interventions: Drug: Casein phosphopeptide amorphous calcium phosphate; Procedure: Atraumatic restorative treatment

• Registration Number: NCT04303767
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-07
• Last Update Submitted: 2020-03-07
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-08-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test (ART + CPP-ACP)	Casein phosphopeptide amorphous calcium phosphate	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
Test (ART + CPP-ACP)	Atraumatic restorative treatment	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
Control (ART)	Atraumatic restorative treatment	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt