Contact Tightness of Zirconomer Versus Nanohybrid Composite in Occlusoproximal Cavities in Molars

Comparison of Proximal Contact Tightness of Zirconia Reinforced Glass Ionomer Versus Conventional Nanohybrid Resin Composite: a Randomized Clinical Trial

To achieve an optimal contact area is essential to avoid tooth migration, food impaction, and the occurrence of secondary caries. However, proximal restorations constitute challenge for the professional and tight contact points are difficult to obtain depending not only on tools used, but also on type of restorative material. Current tooth-colored restorative materials are not condensable and there is shrinkage with setting. The aim of this study is to compare the proximal contact tightness of zirconia reinforced glass ionomer versus conventional nanohybrid resin composite when used in class II cavities.

Study Overview

• Status: Active, not recruiting
• Conditions: Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth
• Intervention / Treatment: Procedure: Zirconomer; Procedure: Nanohybrid composite

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Manyal
    • Cairo, Manyal, Egypt, 11555
      • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Eligibility Criteria of participants:

Inclusion Criteria of participants:

• Patients with occlusoproximal caries in molars classified as ICDAS III or IV.
• 19-35 years.
• Males or Females.
• Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

• Pregnancy.
• Disabilities.
• Systemic disease or severe medical complications.
• Allergic history concerning methacrylate.
• Rampant caries.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.

• Evidence of severe bruxism, clenching, or temporomandibular joint disorders.

  b- Eligibility Criteria of teeth:

Inclusion Criteria of teeth:

• Occlusoproximal caries in molars classified as ICDAS III or IV.
• Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
• Intact contact with opposing teeth.
• Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

• Extensive carious lesions
• Periapical pathology or signs of pulpal pathology.
• Tooth hypersensitivity.
• Possible prosthodontic restoration of teeth.
• Heavy occlusion and occlusal contacts or history of bruxism.
• Sever periodontal affection.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zirconomer in Class II cavities; Zirconia modified glass ionomer restorative material	Procedure: Zirconomer; zirconia modified glass ionomer
Active Comparator: Nanohybrid composite in Class II cavities; Conventionally used aesthetic restorations in class II	Procedure: Nanohybrid composite; conventional composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Tightness	Measuring the adequacy of proximal contact restoration using intervention ' zirconomer" versus control which is Nanohybrid resin composite. Heaviness of this contact using Modified USPHS criteria. USPHS criteria are standardized in which a dental floss is used. Contact tightness can have one of three scores: Alpha Bravo Charlie	baseline, 3 months, 6 months, 9 months and 1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Alaa F Abdelsalam, phD, Lecturer of conservative dentistry, Cairo University; Principal Investigator: Hadier M Gad, PhD, Lecturer of conservative dentistry, Cairo University; Principal Investigator: Manar A Elmokanen, PhD, Lecturer of conservative dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): September 12, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Class II; Glass Ionomer; Resin composite; Zirconomer; Contact tightness; Occlusoproximal cavities
• Other Study ID Numbers: 2255884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No