NCT06596707

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

August 25, 2023

Last Update Submit

September 11, 2024

Conditions

Keywords

ZirconomerGlass IonomerContact tightnessOcclusoproximal cavitiesResin compositeClass II

Outcome Measures

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

    baseline, 3 months, 6 months, 9 months and 1 year

Study Arms (2)

Zirconomer in Class II cavities

EXPERIMENTAL

Zirconia modified glass ionomer restorative material

Procedure: Zirconomer

Nanohybrid composite in Class II cavities

ACTIVE COMPARATOR

Conventionally used aesthetic restorations in class II

Procedure: Nanohybrid composite

Interventions

ZirconomerPROCEDURE

zirconia modified glass ionomer

Zirconomer in Class II cavities

conventional composite

Nanohybrid composite in Class II cavities

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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:
  • 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.
  • Extensive carious lesions
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry Cairo university

Cairo, Manyal, 11555, Egypt

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal in investigator

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 19, 2024

Study Start

July 12, 2023

Primary Completion

September 12, 2024

Study Completion

November 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations