The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Caries,Dental

Intervention / Treatment
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* Drug: Casein phosphopeptide amorphous calcium phosphate
* Procedure: Atraumatic restorative treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test (ART + CPP-ACP)<br>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<br>* varnish containing calcium and phospate ions which act as a source for tooth remineralization<br>* Other names: MI varnish;Procedure: Atraumatic restorative treatment<br>* excavation of dental caries and restoring with light cured Glass Ionomer Restoration<br>* Other names: ART;|
| Active Comparator: Control (ART)<br>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<br>* excavation of dental caries and restoring with light cured Glass Ionomer Restoration<br>* Other names: ART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Casein Phosphopeptide Amorphous Calcium Phosphate, CPP-ACP, caries affected dentine, dentine repair, Atraumatic Restorative Treatment