CariesNCT06098911
Modified Atraumatic Restorative Treatment Using CPP ACP
A study testing MI varnish in people with Caries, run by Cairo University.
Trial summary
To evaluate the clinical and radiographic success of using Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) under glass ionomer restorations in atraumatic restorative treatment as a biomimetic approach in pediatric dentistry. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- MI varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2024to Sep 2024
- Phase
- Interventional
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical Criteria:
- Children aged 4-7 years. Apparently healthy children. Children with mild to moderate occlusal carious lesions in the mandibular second primary molar indicated for indirect pulp capping.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule.
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption.
Who cannot join
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may have effect on the outcome Children with known allergy to any of the components being utilized. Molars near exfoliation.
- Primary molars with more than half of the root resorbed or with periapical pathology as evident radiographically Mobile or ankylosed molars with no permanent successors
- Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- Refusal of participation as the parent of child has the authority of participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Clinical and Radiographic Evaluation of Casein Phosphopeptide Amorphous Calcium Phosphate Under Glass Ionomer in Atraumatic Restorative Treatment Versus Conventional Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
To evaluate the clinical and radiographic success of using Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) under glass ionomer restorations in atraumatic restorative treatment as a biomimetic approach in pediatric dentistry.
Read the detailed description
With the growing popularity of ART in the field of pediatric dentistry, a great deal of research has been done in recent years. Researchers are keen to explore the rich possibilities and variations of ART technique that can help doctors practice better and do more for their patients. Alternatives include detours to regenerative dentistry, which is becoming more and more popular these days.
CPP ACP is still of great interest in the region due to its remineralizing action. However, to our knowledge, clinical and radiological success involving tissue regeneration by CPP-ACP is understudied. Furthermore, the studies conducted justify the need for further research on the use of CPP-ACP as an indirect material under glass ionomers in ART. Therefore, this study aims to conclude whether CPP ACP has added value in regenerating, reducing pain, and improving repair retention in caries-affected dentin lesions.
- Conditions
- Caries
- Being tested
- MI varnish
- Keywords
- CPP ACP, atraumatic restorative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI varnishDevice
Also called CPP ACP
delivers a powerful dose of fluoride, with the added booster effect of the calcium and phosphate ions through its patented Recaldent™ technology. High initial fluoride release. Minimizes tooth sensitivity and strengthens enamel. Neutral pH of 6,6 enhances enamel and dentin acid resistance and inhibits demineralization
| Study group | Role | What they receive |
|---|---|---|
| MI varnish (CPP ACP) under glass ionomer in ART group | Experimental | Application of a thin layer of casein phosphopeptide amorphous calcium phosphate ( CPP ACP ) varnish as indirect pulp capping material under glass-ionomer (Riva Light cure GC company ) in Atraumatic restorative technique. Receives: Device: MI varnish |
| Conventional ART | No intervention | Placement of glass-ionomer restoration ( Riva Light Cure ) only in Atraumatic restorative technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5
Measured: 12 months
Marginal integrity
Visual and clinical examination (by probe and mirror or any change in color or breakage of restoration, recurrent caries as direct observation) from score 0-5 where 0 gap free marginal interface, 1 indicates mircoleakage occur in 1 surface, 2 in 2 surfaces, 3 in 3 surfaces, 4 in 4 surfaces, 5 loss of whole restoration.
Measured: 12 months
Secondary outcomes (2)
Absence of furcation or periapical radiolucency
Intra oral periapical Xray
Measured: 12 months
Absence of any internal or external root resorption
Intra oral periapical Xray
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 posted25 Oct 2023
- Study start10 Feb 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098911
- Sponsor's protocol ID
- CPP ACP in ART
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Access to final data will be allowed to the operator (principal investigator) and the main and co-supervisors of the study, who aren't involved in assessing the outcome. All data sets will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded to any identifying participant information.
Publications
Bresciani E. Clinical trials with Atraumatic Restorative Treatment (ART) in deciduos and permanent teeth. J Appl Oral Sci. 2006;14 Suppl:14-9. doi: 10.1590/s1678-77572006000700004.
PubMed 19089081
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical and Radiographic Evaluation of Casein Phosphopeptide Amorphous Calcium Phosphate Under Glass Ionomer in Atraumatic Restorative Treatment Versus Conventional Atraumatic Restorative Treatment in Primary Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06098911
- Acronym / sponsor ID
- CPP ACP in ART
- Conditions
- Caries
- Keywords
- CPP ACP, atraumatic restorative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
To evaluate the clinical and radiographic success of using Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) under glass ionomer restorations in atraumatic restorative treatment as a biomimetic approach in pediatric dentistry.
Detailed description
With the growing popularity of ART in the field of pediatric dentistry, a great deal of research has been done in recent years. Researchers are keen to explore the rich possibilities and variations of ART technique that can help doctors practice better and do more for their patients. Alternatives include detours to regenerative dentistry, which is becoming more and more popular these days.
CPP ACP is still of great interest in the region due to its remineralizing action. However, to our knowledge, clinical and radiological success involving tissue regeneration by CPP-ACP is understudied. Furthermore, the studies conducted justify the need for further research on the use of CPP-ACP as an indirect material under glass ionomers in ART. Therefore, this study aims to conclude whether CPP ACP has added value in regenerating, reducing pain, and improving repair retention in caries-affected dentin lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI varnish (CPP ACP) under glass ionomer in ART group | Experimental | Device: MI varnishApplication of a thin layer of casein phosphopeptide amorphous calcium phosphate ( CPP ACP ) varnish as indirect pulp capping material under glass-ionomer (Riva Light cure GC company ) in Atraumatic restorative technique. |
| Conventional ART | No intervention | –Placement of glass-ionomer restoration ( Riva Light Cure ) only in Atraumatic restorative technique. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 4-7 years. Apparently healthy children. Children with mild to moderate occlusal carious lesions in the mandibular second primary molar indicated for indirect pulp capping.
- No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule.
- Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
Key exclusion criteria (5 listed)
- Uncooperative children to avoid time waste and attrition bias.
- Children with systemic disease as some systemic diseases may have effect on the outcome Children with known allergy to any of the components being utilized. Molars near exfoliation.
- Primary molars with more than half of the root resorbed or with periapical pathology as evident radiographically Mobile or ankylosed molars with no permanent successors
- Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- Refusal of participation as the parent of child has the authority of participation.
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 |
|---|---|---|
| MI varnishAlso: CPP ACPdelivers a powerful dose of fluoride, with the added booster effect of the calcium and phosphate ions through its patented Recaldent™ technology. High initial fluoride release. Minimizes tooth sensitivity and strengthens enamel. Neutral pH of 6,6 enhances enamel and dentin acid resistance and inhibits demineralization | Device | MI varnish (CPP ACP) under glass ionomer in ART group |
Primary outcome
Post-operative pain
Time frame: 12 months
Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5
Marginal integrity
Time frame: 12 months
Visual and clinical examination (by probe and mirror or any change in color or breakage of restoration, recurrent caries as direct observation) from score 0-5 where 0 gap free marginal interface, 1 indicates mircoleakage occur in 1 surface, 2 in 2 surfaces, 3 in 3 surfaces, 4 in 4 surfaces, 5 loss of whole restoration.
2 secondary outcomes
Absence of furcation or periapical radiolucency
Time frame: 12 months
Absence of any internal or external root resorption
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Results publication: PubMed 19089081Bresciani E. Clinical trials with Atraumatic Restorative Treatment (ART) in deciduos and permanent teeth. J Appl Oral Sci. 2006;14 Suppl:14-9. doi: 10.1590/s1678-77572006000700004.
- Alexandria universityLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to final data will be allowed to the operator (principal investigator) and the main and co-supervisors of the study, who aren't involved in assessing the outcome. All data sets will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded to any identifying participant information.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MI varnish in people with Caries, run by Cairo University.
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 5 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 mai sherif, BDS (01117777182, mai.sherif@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098911, which also lists 1 linked publication.
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 13 Feb 2024.