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To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.
Restorations replacements are mostly caused by the existence of caries lesions surrounding the restorations, which are commonly referred to as secondary caries .
Secondary or recurrent caries is characterized as "lesions that occur at the edges of previously placed dental restorations" or "caries that develop in association with dental restorations or sealants" (CARS).Proper seal at the tooth surface restoration interface is essential . That's why the most frequently material used is (GIC) with the advantage of chemical adhesion to tooth structure, superior esthetics, and long-term fluoride release providing cariostatic effect, but it has the disadvantage of slow setting rate, low fracture toughness, susceptibility to moisture contamination, dehydration during initial phase of setting, and poor wear resistance.
Resin Modified Glass Ionomer and Composite have always been the preferred material for restoration although several modifications have been made recently to improve its properties, Cent ion N is one of the recent ones.
Cent ion N is a tooth-colored basic filling material for direct restoration. It belongs to the material of Alka sites, with high flexural strength. It also has calcium and fluoride releasing properties comparable to conventional GIC, besides it is quick and easy to use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkasite restorative material in primary molar | Experimental | ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION) |
|
| Glass Ionomer Cement in primary molar | Active Comparator | ARM2: Glass Ionomer Cement(CONTROL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKASITE RESTORATIVE MATERIAL | Other | Restorative material for primary teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrent caries of the tooth | Radiograph &Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Color match of the restoration | Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS) | 12 months |
| Marginal Discoloration of the tooth | by Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS) |
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Inclusion Criteria:
1. Children having carious primary molars without pulp exposure and normal radiograph.
2. Children between age 5 and 7 years. 3. Both male and female are included. 4. Cooperative Children.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ola yasir mahmoud, master candidate | Contact | 00971561565339 | 00201062990481 | yasirola95@gmail.com |
| mohd ya sir, master candidate | Contact | +971555304323 | 00201003276852 | moyasir1999@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sherien Ezz Eldin, Professor | cairo university faculty of pediatric dentistry | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36947344 | Background | Sharma H, Suprabha BS, Shenoy R, Rao A, Kotian H. Clinical effectiveness of alkasite versus nanofilled resin composite in the restoration of occlusal carious lesions in permanent molar teeth of children: a randomized clinical trial. Eur Arch Paediatr Dent. 2023 Jun;24(3):301-311. doi: 10.1007/s40368-023-00788-0. Epub 2023 Mar 22. | |
| Background | Hegazi, R.I., W.E. Jamil, and A. Fawzy, Comparative Evaluation of Clinical Performance of Three Different Glass Hybrid Restorations in High Caries Risk Patients: A Randomized Control Trial. Dental Science Updates, 2023. 4(1): p. 171-183. | ||
| Background | Bepu, D., et al., Alksite-based material to restore endodontically treated teeth: A randomized controlled clinical trial. 2023. | ||
| 35846588 |
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study protocol and statistical analysis
after one year
with other investigator including who will work with systematic review , will provide the clinical study report with the documents above
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005899 | Glass Ionomer Cements |
| ID | Term |
|---|---|
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
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Statistician
| Glass Ionomer Cement | Other | Restorative material for primary teeth |
|
|
| 12 months |
| Marginal Adaptation of the tooth | by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS) | 12 months |
| Anatomic Form of the tooth | by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS) | 12 months |
| Background |
| Pooja MP, Karuna YM, Rao A, Suman E, Natarajan S, Suprabha BS. Comparative Evaluation of the Sealing Ability of an Alkasite Restorative Material and Resin-Modified Glass Ionomer Cement in Primary Molars: An In vivo Study. Contemp Clin Dent. 2022 Apr-Jun;13(2):113-117. doi: 10.4103/ccd.ccd_345_20. Epub 2022 Jun 21. |
| Background | 9. Derchi, G., et al., Clinical Performance of CentionTM Alkasite Restorative Material vs. Glass Ionomer Cement Used in Deciduous Teeth: One-Year Evaluation. Applied Sciences, 2022. 12(21): p. 10845. |
| Background | 8. Attia, R., et al., 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, 2022. 68(4): p. 3881-3894. |
| 35439879 | Background | 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. |
| 34393122 | Background | Mushtaq U, Mushtaq F, Thakur D, Rathee K, Poonia N, Khullar S. Comparative Evaluation of Postoperative Sensitivity Following Restoration of Class I Lesions with Different Restorative Materials: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):650-654. |
| Background | 5. Minocha, A., et al., Comparative evaluation of Cention N and Amalgam in Class II posterior restorations. UNIVERSITY JOURNAL OF DENTAL SCIENCES, 2021. 7(1). |
| Background | 4. Roulet, J., et al., In vitro wear of two bioactive composites and a glass ionomer cement. DZZ International, 2019. 1(1): p. 24-30. |
| Background | 3. Dodiya, P.V., et al., Clinical evaluation of cention-n and nano hybrid composite resin as a restoration of noncarious cervical lesion. J Dent Specialities, 2019. 7(1): p. 3-5. |
| Background | 2. Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration. 1995. |
| Background | 1. Class, V., Comparative evaluation of microleakage of three different restorative materials (Cention N, Zirconomer improved and Glass hybrid restorative system) in Class V cavity restoration using stereomicroscope: In vitro study. |
| D013676 |
| Technology, Industry, and Agriculture |