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

NCT ID: NCT06195449

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tooth Decay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Statistician

Study Groups

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Alkasite restorative material in primary molar

ARM 1 : ALKASITE RESTORATIVE MATERIAL( INTERVENTION)

Group Type EXPERIMENTAL

ALKASITE RESTORATIVE MATERIAL

Intervention Type OTHER

Restorative material for primary teeth

Glass Ionomer Cement in primary molar

ARM2: Glass Ionomer Cement(CONTROL)

Group Type ACTIVE_COMPARATOR

Glass Ionomer Cement

Intervention Type OTHER

Restorative material for primary teeth

Interventions

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ALKASITE RESTORATIVE MATERIAL

Restorative material for primary teeth

Intervention Type OTHER

Glass Ionomer Cement

Restorative material for primary teeth

Intervention Type OTHER

Other Intervention Names

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cention n GIC

Eligibility Criteria

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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

* 1\. Patients with systemic diseases. 2. Parent refuse to participate.
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ola Yasir Abdulaziz Mahmoud

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherien Ezz Eldin, Professor

Role: STUDY_DIRECTOR

cairo university faculty of pediatric dentistry

Central Contacts

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ola yasir mahmoud, master candidate

Role: CONTACT

00971561565339 ext. 00201062990481

mohd ya sir, master candidate

Role: CONTACT

+971555304323 ext. 00201003276852

References

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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.

Reference Type BACKGROUND
PMID: 36947344 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 35846588 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 35439879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34393122 (View on PubMed)

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).

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

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alkasite material

Identifier Type: -

Identifier Source: org_study_id

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