Clinical Comparison of Restorative Materials

NCT06637605 | Active Not Recruiting

• 1 other identifier: RTEUDHFMKARADAS003
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.

Conditions

Dental Caries

Keywords

Dental caries; Restorative material; Composite resin; Deep caries

Outcome Measures

Primary Outcomes (1)

• World Dental Federation criteria (FDI)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The characteristics of the teeth were recorded before the restorative procedures. Periapical radiographs were used to determine the status and extent of caries and any potential periodontal or periapical pathology that might require endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. As a result of the clinical and radiographic evaluations, teeth with deep caries lesions according to the ESE (European Society of Endodontology) criteria or those with radiographically reaching ¾ of the dentin but with a hard dentin zone between the caries and the pulp were included in the study.

You may qualify if:

• Systemically healthy patients aged 18 and over
• Patients with good oral hygiene.
• Vital teeth are to be included in the study.
• The presence of an antagonist and a contact tooth for the tooth to be restored.
• Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.

You may not qualify if:

• Patients with a history of bruxism and periodontal disease
• Patients under 18 years of age
• Spontaneous pain in the tooth to be restored
• Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
• Observation of mechanical perforation during caries cleaning
• Patients suspected of pregnancy or pregnant

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

53020

Rize, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: February 23, 2023
• Primary Completion: August 23, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)