Clinical Evaluation of Bulk-fill Restorative Materials

NCT06109987 | Completed

• 1 other identifier: RTEUDHFMKARADAS002
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.

Conditions

Caries; Dentin

Outcome Measures

Primary Outcomes (1)

• Evaluation of different restorative materials

  Restored teeth were evaluated according to FDI criteria.

  Baseline

Interventions

World Dental Federation criteria (FDI) OTHER

Restorations were evaluated with FDI criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Teeth with primary caries that extends into the middle or outer one-third of the dentin (D1 or D2) in radiographs were included in the study. Visually, teeth with visible signs of enamel breakdown or moderate demineralization of dentin (ICDAS 4) in occlusal and smooth surfaces were included in the study.

You may qualify if:

• Voluntarily agreed to participate in the study after being informed about the study.
• Volunteer must not be under 18 years of age
• No systemic disease
• Having healthy oral hygiene
• As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
• The tooth to be restored is vital

You may not qualify if:

• Refusal to participate in the study after being informed about the study
• The patient has a history of teeth grinding
• Volunteer must be under 18 years of age
• The volunteer is undergoing or will begin orthodontic treatment
• The volunteer has a serious systemic disease
• The tooth to be restored has endodontic and periodontal problems
• Volunteer's pregnancy status
• Extraction of one of the teeth opposite or in contact with the tooth to be restored

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Muhammet Karadaş

Rize, Merkez, 53100, Turkey (Türkiye)

Location

Study Officials

• Muhammet 53 Karadaş, PhD

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan Professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: October 11, 2021
• Primary Completion: July 15, 2022
• Study Completion: September 17, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)