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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkasite-based Restorations (Cention N) | Experimental | The children assigned to this intervention group will have alkasite-based restorations for the treatment of Class I carious lesion in primary molars. |
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| Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite). | Active Comparator | The children assigned to the comparator group will undergo class I cavity restorations using nano-hybrid resin composite |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkasite-based composite restorations | Other | Alkasite-based restorations will be used in the treatment of class I carious lesion in primary molars. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
• Children aged 4-6 years of both sexes.
Teeth:
Exclusion Criteria:
Children:
Teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusra Hashim Khogali, Bachelor's degree in dentistry | Contact | +1(438)8766528 | Yusra.kheir@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Cairo Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Attia, R., Sabry, R., Elafefy, A., & Essa, M. (2022). Clinical Performance of Alkasite Dental Material and High Viscosity Glass Ionomer Restorations in Class I Cavities. Comparative Study for One Year Follow Up. Egyptian Dental Journal, 68(4), 3881-3894. | ||
| 35439879 | Result | Arora D, Jain M, Suma Sogi HP, Shahi P, Gupta I, Sandhu M. In vivo evaluation of clinical performance of Cention N and glass ionomer cement in proximal restorations of primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):23-29. doi: 10.4103/jisppd.jisppd_108_21. |
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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)
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The children, outcome assessors, and the statistician will be blinded to the study.
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| Nano-hybrid resin composite | Other | Nanohybrid composite will be used in the restoration of Class I carious lesions in primary molars. |
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| 12 months |