Caries,DentalPhase 2NCT04303767
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine
A Phase 2 study testing Casein phosphopeptide amorphous calcium phosphate and Atraumatic restorative treatment in people with Caries,Dental, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Casein phosphopeptide amorphous calcium phosphate and Atraumatic restorative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)
Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration
Read the 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.
- Conditions
- Caries,Dental
- Being tested
- Casein phosphopeptide amorphous calcium phosphate, Atraumatic restorative treatment
- Keywords
- Casein Phosphopeptide Amorphous Calcium Phosphate, CPP-ACP, caries affected dentine, dentine repair, Atraumatic Restorative Treatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casein phosphopeptide amorphous calcium phosphateDrug
Also called MI varnish
varnish containing calcium and phospate ions which act as a source for tooth remineralization
Atraumatic restorative treatmentProcedure or surgery
Also called ART
excavation of dental caries and restoring with light cured Glass Ionomer Restoration
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Casein phosphopeptide amorphous calcium phosphate; Procedure: Atraumatic restorative treatment |
| 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 Receives: Procedure: Atraumatic restorative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
- Investigators
- Mohamed A. Bayoumi, MSc, Principal investigator, Pharos University in AlexandriaAzza G. Hanno, Professor, Study director, Alexandria UniversityKarin M. Dowidar, Professor, Study director, Alexandria UniversitySamia S. Omar, Professor, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303767
- Sponsor's protocol ID
- 00010556-IORG0008839
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reparative Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Varnish on Caries Affected Dentine in Primary Teeth (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04303767
- Acronym / sponsor ID
- 00010556-IORG0008839
- Conditions
- Caries,Dental
- Keywords
- Casein Phosphopeptide Amorphous Calcium Phosphate, CPP-ACP, caries affected dentine, dentine repair, Atraumatic Restorative Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (ART + CPP-ACP) | Experimental | Drug: Casein phosphopeptide amorphous calcium phosphate, Procedure: Atraumatic restorative treatmentIn 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 | Procedure: Atraumatic restorative treatmentin 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 |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casein phosphopeptide amorphous calcium phosphateAlso: MI varnishvarnish containing calcium and phospate ions which act as a source for tooth remineralization | Drug | Test (ART + CPP-ACP) |
| Atraumatic restorative treatmentAlso: ARTexcavation of dental caries and restoring with light cured Glass Ionomer Restoration | Procedure or surgery | Control (ART), Test (ART + CPP-ACP) |
Primary outcome
Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars.
Time frame: 12 months
this is by evaluating the clinical and radiographic data and also by descriptive histological assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A. Bayoumi, MSc principal investigator
Pharos University in Alexandria
Azza G. Hanno, Professor study director
Alexandria University
Karin M. Dowidar, Professor study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Casein phosphopeptide amorphous calcium phosphate and Atraumatic restorative treatment in people with Caries,Dental, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Bayoumi, MSc (0122273853, mohamed.bayoumi@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the reparative ability of Casein Phosphopeptide Amorphous Calcium Phosphate varnish on caries affected dentine in primary molars. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.