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

NCT06185881 | Completed DMC

• 1 other identifier: CEBD 5/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Caries

Keywords

fiber reinforced glass ionomer

Outcome Measures

Primary Outcomes (1)

• Change in Marginal integrity score

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

  [Time Frame: Baseline, 6 months, 12 months]

Secondary Outcomes (3)

• Change in Marginal discoloration, Color match, Gross fracture scores

  [Time Frame: Baseline, 6 months, 12 months]

• Change in Secondary caries scores

  [Time Frame: Baseline, 6 months, 12 months]

• Change in Post operative Hypersensitivity

  [Time Frame: Baseline, 7 days, 6 months]

Study Arms (2)

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

EXPERIMENTAL

Procedure: restoration of cervical carious teeth

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

ACTIVE COMPARATOR

Procedure: restoration of cervical carious teeth

Interventions

restoration of cervical carious teeth PROCEDURE

restoration of carious cervical lesions by glass ionomer

Resin modified glass ionomer restoration. (Fugi II LC, GC Europe); Short fiber reinforced resin modified glass ionomer restorations (GC Europe)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11331, Egypt

Location

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and both assessors will be blind to the type of material used
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Model Details: split mouth

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 28, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)