Trial | NCT04303767  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    132
Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration
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 Started
Mar 01
2020
Anticipated
Primary Completion
Aug 01
2020
Anticipated
Study Completion
Feb 01
2021
Anticipated
Last Update
Mar 11
2020

Drug Casein phosphopeptide amorphous calcium phosphate

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

  • Other names: MI varnish

Procedure Atraumatic restorative treatment

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

  • Other names: ART

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

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

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.
No Results Posted