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

Not Applicable

Completed

• Conditions: Cervical Caries
• Interventions: Procedure: restoration of cervical carious teeth

• Registration Number: NCT06185881
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-04-01
• Study First Submitted: 2023-12-15
• Study Completion: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Study First Posted: 2023-12-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resin modified glass ionomer restoration. (Fugi II LC, GC Europe)	restoration of cervical carious teeth	-
Short fiber reinforced resin modified glass ionomer restorations (GC Europe)	restoration of cervical carious teeth	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Secondary caries scores	[Time Frame: Baseline, 6 months, 12 months]	Modified USPHS criteria with Alpha and Charlie scores (Categorical)
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 Post operative Hypersensitivity	[Time Frame: Baseline, 7 days, 6 months]	Modified USPHS criteria with Alpha and Charlie scores (Categorical)

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt