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

NCT06195449 | Not Yet Recruiting DMC

• 1 other identifier: alkasite material
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Tooth Decay

Keywords

Alkasite restorative material; cention N; GIC; Primary molars

Outcome Measures

Primary Outcomes (1)

• recurrent caries of the tooth

  Radiograph \&Visual inspection using Modified United States Public Health Service Ryge criteria (USPHS

  12 months

Secondary Outcomes (4)

• Color match of the restoration

  12 months

• Marginal Discoloration of the tooth

  12 months

• Marginal Adaptation of the tooth

  12 months

• Anatomic Form of the tooth

  12 months

Study Arms (2)

Alkasite restorative material in primary molar

EXPERIMENTAL

ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)

Other: ALKASITE RESTORATIVE MATERIAL

Glass Ionomer Cement in primary molar

ACTIVE COMPARATOR

ARM2: Glass Ionomer Cement(CONTROL)

Other: Glass Ionomer Cement

Interventions

ALKASITE RESTORATIVE MATERIAL OTHER

Restorative material for primary teeth

Also known as: cention n

Alkasite restorative material in primary molar

Glass Ionomer Cement OTHER

Restorative material for primary teeth

Also known as: GIC

Glass Ionomer Cement in primary molar

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Children having carious primary molars without pulp exposure and normal radiograph.
• \. Children between age 5 and 7 years. 3. Both male and female are included. 4. Cooperative Children.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (13)

• 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.

  PMID: 36947344 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.

  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.

  PMID: 35846588 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.

  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.

  PMID: 35439879 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.

  PMID: 34393122 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.

  BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Glass Ionomer Cements

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sherien Ezz Eldin, Professor

  cairo university faculty of pediatric dentistry

  STUDY DIRECTOR

Central Study Contacts

ola yasir mahmoud, master candidate

CONTACT

00971561565339; yasirola95@gmail.com

mohd ya sir, master candidate

CONTACT

+971555304323; moyasir1999@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 8, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after one year
• Access Criteria: with other investigator including who will work with systematic review , will provide the clinical study report with the documents above