CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

NCT05559333 | Completed

• 1 other identifier: KA-17057
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.

Conditions

Class I Dental Caries

Keywords

glass ionomer cements; bioactive materials

Outcome Measures

Primary Outcomes (1)

• Retention Alpha for at least 90% of the restorations

  The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assesed as alpha (retentive restoratation) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.

  24 months

Secondary Outcomes (1)

• marginal adaptation score alpha

  24 months

Study Arms (4)

zirconomer

ACTIVE COMPARATOR

zirconia reinforced glass ionomer cement

Procedure: class I restoration placement

Equia Fil

ACTIVE COMPARATOR

High viscosity glass ionomer cement

Procedure: class I restoration placement

glass carbomer

ACTIVE COMPARATOR

glass ionomer cement containing nano sized- carbonized particles.

Procedure: class I restoration placement

Tetric-evo ceram bulk fill

ACTIVE COMPARATOR

Bulk fill composite resin

Procedure: class I restoration placement

Interventions

class I restoration placement PROCEDURE

zirconomer, glass carbomer, glass ionomer and composite resin class I restorations were placed.

Equia Fil; Tetric-evo ceram bulk fill; glass carbomer; zirconomer

Eligibility Criteria

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

You may qualify if:

• patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

You may not qualify if:

• patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: randomized-split mouth clinical trial

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 29, 2022
• Study Start: April 12, 2017
• Primary Completion: February 15, 2018
• Study Completion: March 24, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

TU (1)