ClinicalTrials.gg
CompletedNCT06185881Updated Feb 20, 2024

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

An interventional study of restoration of cervical carious teeth in Cervical Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

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

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Mar 2022, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cervical Caries

Browse trials for

Keywords

  • fiber reinforced glass ionomer
03

In context

Root Caries

39 studies on the registry are indexed under Root Caries; 14 are open to participants now.

This study's enrollment of 80 is above the median of 62 across 35 interventional studies indexed under Root Caries.

Browse Root Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 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
18 Years to 38 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Short fiber reinforced resin modified glass ionomer restorations (GC Europe)

    Procedure: restoration of cervical carious teeth

  • Active comparator
    Resin modified glass ionomer restoration. (Fugi II LC, GC Europe)

    Procedure: restoration of cervical carious teeth

Interventions

  • Procedurerestoration of cervical carious teeth

    restoration of carious cervical lesions by glass ionomer

06

What researchers measure

Primary outcomes

  1. Change in Marginal integrity score

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

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

Secondary outcomes

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

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

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

  2. Change in Secondary caries scores

    Modified USPHS criteria with Alpha and Charlie scores (Categorical)

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

  3. Change in Post operative Hypersensitivity

    Modified USPHS criteria with Alpha and Charlie scores (Categorical)

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

07

Study locations

1 site
  • Faculty of Dentistry
    Cairo, 11331, 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 Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06185881
Lead sponsor
Cairo University
Responsible party
Rawda Hesham Abd ElAziz (Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University., Cairo University) — Principal investigator
First posted
Dec 29, 2023
Start date
Mar 1, 2022
Primary completion
Apr 1, 2023
Completion
Dec 28, 2023
Last update
Feb 20, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion