Skip to main content
OpenTrials
Completed

NCT Number: NCT06185881

Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

This research proposal is introduced to clinically test short fiber reinforced glass ionomer material from GC Europe due to gap of knowledge present in this area. It is characterized by higher flexural strength compared to resin modified glass ionomer (RMGIC). Additionally, the short fibers provided effective toughening of the RMGIC matrix by a fiber bridging mechanism.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Caries Dental Caries Root Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 11331, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with untreated cervical carious lesions
  • Patients with normal occlusion
  • Vital teeth with carious cervical lesion with asymptomatic vital pulp.
  • Teeth with no or minimum mobility.
  • Teeth with normal occlusion.
  • Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion criteria

  • Patients who are unable to return for recall appointments
  • Presence of abnormal oral, medical or mental conditions.
  • Patients with severe medical diseases.
  • Patients with xerostomia
  • Patients with parafunctional habits.
  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Severe periodontal problems.
  • Non carious cervical lesions.

Treatment and study plan

restoration of cervical carious teeth

Procedure

restoration of carious cervical lesions by glass ionomer

Primary outcomes

  1. Change in Marginal integrity score

    Time frame: [Time Frame: Baseline, 6 months, 12 months]

    Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Secondary outcomes

  1. Change in Marginal discoloration, Color match, Gross fracture scores

    Time frame: [Time Frame: Baseline, 6 months, 12 months]

    Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

  2. Change in Secondary caries scores

    Time frame: [Time Frame: Baseline, 6 months, 12 months]

    Modified USPHS criteria with Alpha and Charlie scores (Categorical)

  3. Change in Post operative Hypersensitivity

    Time frame: [Time Frame: Baseline, 7 days, 6 months]

    Modified USPHS criteria with Alpha and Charlie scores (Categorical)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance of Short Fiber Reinforced Resin Modified Glass Ionomer Restorations Versus Resin Modified Glass Ionomer Restorations in Cervical Carious Teeth (1y Randomized Clinical Trial)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.