Modified Atraumatic Restorative Treatment Using CPP ACP
NCT ID: NCT06098911
Last Updated: 2024-02-13
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-02-10
2024-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MI varnish (CPP ACP) under glass ionomer in ART group
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.
MI varnish
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
Conventional ART
Placement of glass-ionomer restoration ( Riva Light Cure ) only in Atraumatic restorative technique.
No interventions assigned to this group
Interventions
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MI varnish
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
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
4 Years
7 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Mai Sherif
Dr. Mai Sherif
Central Contacts
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References
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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.
Related Links
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Alexandria university
Other Identifiers
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CPP ACP in ART
Identifier Type: -
Identifier Source: org_study_id
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