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

Cervical Caries Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06185881
• Other study ID #: CEBD 5/2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 28, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 28, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Caries
• Root Caries

Intervention

Procedure:
• restoration of cervical carious teeth
restoration of carious cervical lesions by glass ionomer

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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