CClinicalTrials.gg
Active, not recruitingNCT06596707Updated Sep 19, 2024

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

An interventional study of Zirconomer and Nanohybrid composite in Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Open to participants aged 19 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years to 35 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Contact Tightness in Restoring Proximal Surfaces in Posterior Teeth

Keywords

  • Zirconomer
  • Glass Ionomer
  • Contact tightness
  • Occlusoproximal cavities
  • Resin composite
  • Class II
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Zirconomer in Class II cavities

    Zirconia modified glass ionomer restorative material

    Procedure: Zirconomer

  • Active comparator
    Nanohybrid composite in Class II cavities

    Conventionally used aesthetic restorations in class II

    Procedure: Nanohybrid composite

Interventions

  • ProcedureZirconomer

    zirconia modified glass ionomer

  • ProcedureNanohybrid composite

    conventional composite

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline, 3 months, 6 months, 9 months and 1 year

07

Study locations

1 site
  • Faculty of dentistry Cairo university
    Cairo, Manyal 11555, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06596707
Lead sponsor
Cairo University
Responsible party
Alaa Fathi Abdelsalam (Principal in investigator, Cairo University) — Principal investigator
First posted
Sep 19, 2024
Start date
Jul 12, 2023
Primary completion
Sep 12, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Sep 19, 2024

Study contacts

Alaa F Abdelsalam, phD
principal investigator · lecturer of conservative dentistry, Cairo university
Hadier M Gad, PhD
principal investigator · Lecturer of conservative dentistry, Cairo university
Manar A Elmokanen, PhD
principal investigator · Lecturer of conservative dentistry, Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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