Modified Atraumatic Restorative Treatment Using CPP ACP

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06098911
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Anticipated Duration (Months): 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries	Device: MI varnish	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Nov 3, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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; Other Names: CPP ACP
No Intervention: Conventional ART Placement of glass-ionomer restoration ( Riva Light Cure ) only in Atraumatic restorative technique.

Outcome Measures

Primary Outcome Measures

1. Post-operative pain [6 months]

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

2. Marginal integrity [6 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.

Secondary Outcome Measures

1. Absence of furcation or periapical radiolucency [6 months]

   Intra oral periapical Xray

2. Absence of any internal or external root resorption [6 months]

   Intra oral periapical Xray

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alexandria university

Publications

None provided.

• Responsible Party: Mai Sherif, Dr. Mai Sherif, Cairo University
• ClinicalTrials.gov Identifier: NCT06098911
• Other Study ID Numbers: CPP ACP in ART
• First Posted: Oct 25, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Mai Sherif, Dr. Mai Sherif, Cairo University: CPP ACP; atraumatic restorative treatment

Study Results

No Results Posted as of Oct 25, 2023