Modified Atraumatic Restorative Treatment Using CPP ACP

Cairo University (CU)

Status: Not yet enrolling

Conditions: Caries

Treatments: Device: MI varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT06098911

CPP ACP in ART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

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.

Exclusion Criteria:

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

MI varnish (CPP ACP) under glass ionomer in ART group

Experimental group

Description:

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.

Treatment:

Device: MI varnish

Conventional ART

No Intervention group

Description:

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