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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06185881

Enrollment

Registered

2023-12-29

Start date

2022-03-01

Completion date

2023-12-28

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Caries

Keywords

fiber reinforced glass ionomer

Brief 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.

Interventions

PROCEDURErestoration of cervical carious teeth

restoration of carious cervical lesions by glass ionomer

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants and both assessors will be blind to the type of material used

Intervention model description

split mouth

Eligibility

Sex/Gender

ALL

Age

18 Years to 38 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Marginal integrity score	[Time Frame: Baseline, 6 months, 12 months]	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)

Secondary

Measure	Time frame	Description
Change in Marginal discoloration, Color match, Gross fracture scores	[Time Frame: Baseline, 6 months, 12 months]	Modified USPHS criteria with Alpha, Bravo and Charlie scores (Categorical)
Change in Secondary caries scores	[Time Frame: Baseline, 6 months, 12 months]	Modified USPHS criteria with Alpha and Charlie scores (Categorical)
Change in Post operative Hypersensitivity	[Time Frame: Baseline, 7 days, 6 months]	Modified USPHS criteria with Alpha and Charlie scores (Categorical)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026