Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult With Class V Carious

Clinical Evaluation of Bulk-fill Alkasite Restoration Versus Resin Modified Glass Ionomer in Adult Patients With Class V Carious Lesions Over One Year Period: Randomized Clinical Trial

Cention N will have the same clinical performance as resin-modified glass ionomer in cervical carious lesions. Evaluation of restorations will be done at baseline, six months, and one year according (USPHS) criteria.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Lesion
• Intervention / Treatment: Other: Alkasite bioactive restorative material.; Other: Resin Modified Glass Ionomer

Detailed Description

In this study, Class V carious lesions were restored using two different restorative materials either resin modified glass ionomer or Cention N restorative materials. This study will be held in the restorative clinic at Future University in Egypt. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept, 12 their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received. The first group (A) will be received resin modified glass ionomer restorative material and the second group (B) will be received Cention N restorative materials. Each restoration will be evaluated for clinical parameters after finishing and polishing at baseline and regular recalls of 6 months and one year.

The restorations will be clinically examined according to modified USPHS criteria in terms of marginal adaptation, anatomic form, color match, marginal discoloration, secondary caries, postoperative sensitivity and retention. The information that will be obtained will be collected and statistically analyzed

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients with High caries risk.
• Patients with poor oral hygiene.
• Patients with untreated cervical caries lesion.
• patient aging ≥18 years.
• Absence of tooth mobility
• Absence of abnormal occlusion.
• Patients with good likelihood of recall availability.

Exclusion criteria:

• Patients with cervical caries lesions need crown restoration.
• Non-vital teeth.
• Evidence of parafunctional habits.
• Teeth supporting removable prosthesis.
• Periapical Abscess or Fistula.
• Patients with systemic disease.
• Patients with xerostomia.
• Participants with a history of allergy to any component of restorations will be used in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cention N; Intervention Alkasite Restoration will be used to restore cervical carious in adult patients.	Other: Alkasite bioactive restorative material.; Alkasite restorative is a category of filling material, like compomer, and is essentially a subgroup of the composite resin. Cention N is a urethane dimethacrylate (UDMA)-based, self-curing powder/liquid restorative with optional additional light curing. The liquid comprises of dimethacrylates and initiators, while the powder contains various glass fillers, initiators, and pigments. It is radio opaque and contains alkaline glass fillers capable of releasing fluoride, calcium, and hydroxide ions. Due to the sole use of cross-linking methacrylate monomers in combination with a stable, efficient self-cure initiator, Cention N displays a high polymer network density and degree of polymerization over the complete depth of the restoration.; Other Names: (Cention N).
Active Comparator: Resin Modified Glass Ionomer; Comparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients.	Other: Resin Modified Glass Ionomer; The resin-modified glass ionomer materials are hybrid materials of traditional glass ionomer cement with a small addition of light-curing resin, and hence exhibit properties intermediate to the two, with some characteristics superior to conventional glass ionomer materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Marginal adaptation)	(USPHS) criteria	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)	(USPHS) criteria	12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 381020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: Expecting to have all the data by October 2022
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No