Alkasite-based Restorations, Nano-hybrid Resin Composite
Conditions
Keywords
Alkasite-based Restorations, Cention N, Nano-hybrid resin composite, clinical performance, secordary caries, Children, Class I
Brief summary
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.
Detailed description
This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.
Interventions
OTHERAlkasite-based composite restorations
Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.
OTHERNano-hybrid resin composite
Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The children, outcome assessors, and the statistician will be blinded to the study.
Intervention model description
The included children with class I cavity carious lesions will be assigned to either alkasite-based restoration (Intervention group) or Nano-hybrid resin composite (Comparison group)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* • Children aged 4-6 years of both sexes. * Cooperative children. * Apparently medically fit children according to parental history. * Children whose parents agree to sign the informed consent. * Children whose parents will be able to attend the follow-up. Teeth: * Primary molars with occlusal carious lesions (Class I), indicated for direct restorations. * Teeth without signs of pulpal involvement, abscess, or fractures.
Exclusion criteria
Children: * Children with systemic or mental disorders. * Children whose parents refused to sign the informed consent. * Noncompliant parent. * Uncooperative children. Teeth: * Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility). * Teeth with periapical pathology, internal or external root resorption, or mobility. * Non-restorable teeth or lacking sufficient structure for restoration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of secondary caries | 12 months | The primary outcome of this study will be the evaluation of secondary caries incidence at 3, 6, and 12 months following restoration. Assessment will be carried out using the United States Public Health Service (USPHS) criteria, with restorations scored on a scale ranging from Alpha (clinically excellent) to Delta (clinically unacceptable. Each restoration will be scored as Alpha (A) if there is no evidence of secondary caries and the tooth-restoration interface remains intact. A score of Bravo (B) will indicate a questionable or suspicious area, such as slight marginal staining without definite cavitation. Charlie (C) will be assigned when definite secondary caries are observed, including softness or cavitation at the restoration margin, necessitating replacement of the restoration. Delta (D) will be used for severe carious lesions extending beneath the restoration, requiring immediate intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical evaluation of restoration fracture | 12 months | The secondary outcomes will include the clinical evaluation of restoration fracture at 3, 6, and 12 months. The occurrence of restoration fracture will be evaluated using the United States Public Health Service (USPHS) criteria. Each restoration will be scored as Alpha (A) if no fracture is present and the restoration remains intact. A score of Bravo (B) will indicate minor chipping or superficial fracture that does not compromise function. Charlie (C) will be assigned when a fracture is evident that affects the integrity or function of the restoration, necessitating repair or replacement. Delta (D) will be used for severe fracture resulting in complete loss of the restoration, requiring immediate replacement. |
Countries
Egypt
Contacts
Primary ContactYusra Hashim Khogali, Bachelor's degree in dentistry
Outcome results
None listed