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

NCT ID: NCT04716517

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-12-01

Brief 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.

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

Conditions

Cervical Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cention N

Intervention Alkasite Restoration will be used to restore cervical carious in adult patients.

Group Type: EXPERIMENTAL

Alkasite bioactive restorative material.

Intervention Type: OTHER

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

Comparator Resin-modified glass ionomer material will be used to restore cervical carious in adult patients.

Group Type: ACTIVE_COMPARATOR

Resin Modified Glass Ionomer

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

(Cention N).

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

hadeel alsalamony

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Al-Salamony H, Akah M, Naguib EA, Safwat OM. Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial. J Contemp Dent Pract. 2024 Dec 1;25(12):1127-1134. doi: 10.5005/jp-journals-10024-3787.

Reference Type: DERIVED

PMID: 40079991 (View on PubMed)

Other Identifiers

381020

Identifier Type: -

Identifier Source: org_study_id