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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06109987
Other study ID # RTEUDHFMKARADAS002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 11, 2021
Est. completion date September 17, 2023

Study information

Verified date February 2024
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V restorations. The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined. Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries. Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p < 0.05).


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date September 17, 2023
Est. primary completion date July 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
World Dental Federation criteria (FDI)
Restorations were evaluated with FDI criteria.

Locations

Country Name City State
Turkey Muhammet Karadas Rize Merkez

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of different restorative materials Restored teeth were evaluated according to FDI criteria. Baseline
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