NCT06098911

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

October 12, 2023

Last Update Submit

February 10, 2024

Conditions

Caries

Keywords

CPP ACPatraumatic restorative treatment

Outcome Measures

Primary Outcomes (2)

  • Post-operative pain

    Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5

    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.

    12 months

Secondary Outcomes (2)

  • Absence of furcation or periapical radiolucency

    12 months

  • Absence of any internal or external root resorption

    12 months

Study Arms (2)

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.

Device: MI varnish

Conventional ART

NO INTERVENTION

Placement of glass-ionomer restoration ( Riva Light Cure ) only in Atraumatic restorative technique.

Interventions

MI varnishDEVICE

delivers a powerful dose of fluoride, with the added booster effect of the calcium and phosphate ions through its patented Recaldentâ„¢ 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

Also known as: CPP ACP
MI varnish (CPP ACP) under glass ionomer in ART group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19089081RESULT

Related Links

Central Study Contacts

mai sherif, BDS

CONTACT

01117777182mai.sherif@dentistry.cu.edu.eg

hany sabr, PHd

CONTACT

01225519667Hany.sabr@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mai Sherif

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 25, 2023

Study Start

February 10, 2024

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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.