Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement

Tooth Decay Clinical Trial

— GIC  

Official title:

Clinical and Radiographic Evaluation of Alkasite Restorative Material Versus Glass Ionomer Cement in Restoration of Primary Molars: Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195449
• Other study ID #: alkasite material
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: ola yasir mahmoud, master candidate
• Phone: 00971561565339
• Email: yasirola95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical and radiographic performance of Alkasite restorative material versus glass ionomer in restoration of primary molars.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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:

• 1. Patients with systemic diseases. 2. Parent refuse to participate.

Related Conditions & MeSH terms

• Dental Caries
• Tooth Decay

Intervention

Other:
• ALKASITE RESTORATIVE MATERIAL
Restorative material for primary teeth
• Glass Ionomer Cement
Restorative material for primary teeth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (13)

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.

2. Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration. 1995.

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.

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.

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).

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.

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.

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. — View Citation

Bepu, D., et al., Alksite-based material to restore endodontically treated teeth: A randomized controlled clinical trial. 2023.

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.

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent caries of the tooth	Radiograph &Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS	12 months
Secondary	Color match of the restoration	Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)	12 months
Secondary	Marginal Discoloration of the tooth	by Visual Inspection using Modified United States Public Health Service Ryge criteria (USPHS)	12 months
Secondary	Marginal Adaptation of the tooth	by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)	12 months
Secondary	Anatomic Form of the tooth	by Visual Inspection and Explorer using Modified United States Public Health Service Ryge criteria (USPHS)	12 months