Modified Atraumatic Restorative Treatment Using CPP ACP
- Conditions
- Caries
- Interventions
- Device: MI varnish
- Registration Number
- NCT06098911
- Lead Sponsor
- Cairo University
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MI varnish (CPP ACP) under glass ionomer in ART group MI varnish 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.
- Primary Outcome Measures
Name Time Method Post-operative pain 12 months Verbal question to the patient form score 0-5 where o is no pain and maximum pain indicates 5
Marginal integrity 12 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
Name Time Method Absence of furcation or periapical radiolucency 12 months Intra oral periapical Xray
Absence of any internal or external root resorption 12 months Intra oral periapical Xray