The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Hams Hamed Abdelrahman

Status and phase: Unknown; Phase 2

Conditions: Caries,Dental

Treatments: Drug: Casein phosphopeptide amorphous calcium phosphate; Procedure: Atraumatic restorative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04303767

00010556-IORG0008839

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Test (ART + CPP-ACP)

Experimental group

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

Treatment:

Procedure: Atraumatic restorative treatment

Drug: Casein phosphopeptide amorphous calcium phosphate

Control (ART)

Active Comparator group

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

Treatment:

Procedure: Atraumatic restorative treatment