Clinical trial NCT04303767: The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
Official title: The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Caries,Dental
Keywords: Casein Phosphopeptide Amorphous Calcium Phosphate
CPP-ACP
caries affected dentine
dentine repair
Atraumatic Restorative Treatment
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: 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.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Assess histologically the quality of the formed dentine using the Polarized Light Microscope and Scanning Electron Microscope.
timeFrame: throughout the 12 months
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Pharos University in Alexandria
name: Mohamed A. Bayoumi, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Azza G. Hanno, Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Karin M. Dowidar, Professor
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Samia S. Omar, Professor
role: STUDY_DIRECTOR
References: