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

Cervical Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04716517
• Other study ID #: 381020
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Lesion

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Marginal adaptation)	(USPHS) criteria	12 months
Secondary	Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)	(USPHS) criteria	12 months