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

NCT04716517 | Unknown DMC

• 1 other identifier: 381020
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Lesion

Outcome Measures

Primary Outcomes (1)

• (Marginal adaptation)

  (USPHS) criteria

  12 months

Secondary Outcomes (1)

• Clinical performance (Anatomical form, Secondary caries, marginal discoloration, Postoperative sensitivity, Color match, Retention)

  12 months

Study Arms (2)

Cention N

EXPERIMENTAL

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

Other: Alkasite bioactive restorative material.

Resin Modified Glass Ionomer

ACTIVE COMPARATOR

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

Other: Resin Modified Glass Ionomer

Interventions

Alkasite bioactive restorative material. 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.

Also known as: (Cention N).

Cention N

Resin Modified Glass Ionomer 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

Resin Modified Glass Ionomer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 40079991 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 20, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Expecting to have all the data by October 2022