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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars.
Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars.
Cairo University
Cairo, Cairo Governorate, Egypt
Incidence of secondary caries
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.
Time frame: 12 months
clinical evaluation of restoration fracture
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.
Time frame: 12 months
Yusra Hashim Khogali, Bachelor's degree in dentistry
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