Modified Atraumatic Restorative Treatment Using CPP ACP

Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06098911
• Other study ID #: CPP ACP in ART
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: mai sherif, BDS
• Phone: 01117777182
• Email: mai.sherif[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Caries

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5	12 months
Primary	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	Absence of furcation or periapical radiolucency	Intra oral periapical Xray	12 months
Secondary	Absence of any internal or external root resorption	Intra oral periapical Xray	12 months

External Links

•   Alexandria university