ClinicalTrials.gg
Status unknownNCT05624008Updated Nov 21, 2022

Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients

An interventional study of Bioceramic glass ionomer restoration and Resin modified glass ionomer restoration in Cervical Caries, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-21.

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

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.

02

Conditions studied

  • Cervical Caries

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03

In context

Root Caries

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

This study's planned enrollment of 28 is below 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
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Geriatric patients aged above 55 years
  • Patients with untreated carious lesions
  • Patients who have at least 20 teeth under occlusion
  • 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.
  • Non vital teeth.
  • Teeth with signs or symptoms of pulpitis.
  • Teeth with non carious lesions.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Bioceramic glass ionomer restoration

    Calcium aluminate modified glass ionomer

    Other: Bioceramic glass ionomer restoration

  • Active comparator
    Resin modified glass ionomer restoration

    type II resin modified glass ionomer cement

    Other: Resin modified glass ionomer restoration

Interventions

  • OtherBioceramic glass ionomer restoration

    bioactive glass ionomer with unique biocompatibility and biological regenerative properties

  • OtherResin modified glass ionomer restoration

    A hybrid of glass ionomer and composite resin with acid-base and polymerizable components

06

What researchers measure

Primary outcomes

  1. Change in Marginal adaptation score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

Secondary outcomes

  1. Change in Retention score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

  2. Change in Color match score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

  3. Change in Marginal discoloration score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

  4. Change in Secondary caries score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

  5. Change in Wear score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

  6. Change in Postoperative hypersensitivity score

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

    Time frame: Baseline, 3 months, 6 months, 12 months

07

Study locations

1 of 1 sites recruiting
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 Nov 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05624008
Lead sponsor
Cairo University
Responsible party
Mariam Mohammed Abd Al-Naieem (Master degree candidate, Conservative Dentistry Department, Faculty of Dentistry, Cairo University) — Principal investigator
First posted
Nov 21, 2022
Start date
Jun 1, 2022
Primary completion
Dec 2023 (estimated)
Completion
Feb 2024 (estimated)
Last update
Nov 21, 2022

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 status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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