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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-12-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

split mouth

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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

Group Type EXPERIMENTAL

restoration of cervical carious teeth

Intervention Type PROCEDURE

restoration of carious cervical lesions by glass ionomer

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

Group Type ACTIVE_COMPARATOR

restoration of cervical carious teeth

Intervention Type PROCEDURE

restoration of carious cervical lesions by glass ionomer

Interventions

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restoration of cervical carious teeth

restoration of carious cervical lesions by glass ionomer

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes