A 24-month Clinical Evaluation of Different Bulk-fill Restorative Resins in Class II Restorations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the clinical performance of three different bulk-fill restorative resin materials; a bulk fill resin composite, a flowable bulk fill resin composite and a fiber-reinforced resin in Class II restorations over a period of 24 months.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Performance of Fiber-Reinforced Dentin Replacement Materials

NCT07320885

Caries; Dentin Caries Class II

COMPLETED NA

Comparison of Bulk-Fill Composite Resins in Class II Restorations

NCT06212141

Class II Dental Caries

ACTIVE_NOT_RECRUITING NA

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

Class I Dental Caries

COMPLETED NA

5-year Clinical Follow-up of Restorative Materials

NCT06393270

Dental Caries Class II Dental Caries

COMPLETED

Evaluation of ART Restorations Using Two Different Bulk-Fill Restorative Materials in Primary Molars

NCT06771362

Dentin Caries

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to evaluate the 24-month clinical performance of three different bulk-fill restorative resin materials in Class II restorations. Forty patients with at least three approximal lesions in premolar and molar teeth will be participated in the study. A total of 120 Class II cavities will be restored using Tetric EvoCeram Bulk Fill (n=40), SureFil SDR flow + Ceram X mono (n=40), and everX Posterior + G-aenial Posterior (n=40) with their respective adhesives according to the manufacturers' instructions. All restorations will be placed by one operator. The restorations will be evaluated at baseline and at 6, 12, 18, and 24 months using modified USPHS criteria by one examiner. The restoration groups for each category will be compared using Pearson's chi-square test, while Cochran's Q test will be used to compare the changes across different time points within each restorative material (p\<0.05).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

single

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tetric EvoCeram BulkFill resin

Randomly applied

Group Type ACTIVE_COMPARATOR

Tetric EvoCeram Bulkfill

Intervention Type OTHER

The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.

Surefil SDR Flowable bulk-fill resin

Randomly applied

Group Type ACTIVE_COMPARATOR

Surefil SDR Flowable bulkfill

Intervention Type OTHER

The preparation will be etched. A two-step etch-and-rinse adhesive, Prime\&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.

everX fiber-reinforced resin

Randomly applied

Group Type ACTIVE_COMPARATOR

everX fiber-reinforced resin

Intervention Type OTHER

The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tetric EvoCeram Bulkfill

The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.

Intervention Type OTHER

Surefil SDR Flowable bulkfill

The preparation will be etched. A two-step etch-and-rinse adhesive, Prime\&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.

Intervention Type OTHER

everX fiber-reinforced resin

The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who accept to participate and sign the informed consent
* Patients who have at least three similar-sized approximal primary caries lesions in premolar and molar teeth.
* The teeth to be restored had a normal occlusal relationship with natural dentition and had adjacent tooth contact and had a normal response to a vitality test with no periapical pathology

Exclusion Criteria

* Patients who don't accept to participate and sign the informed consent
* Patients who have a history of adverse reaction to the test materials
* Patients who are pregnant or lactating, have fewer than 20 teeth
* Patients who have poor oral hygiene, have severe or chronic periodontal disease, have heavy bruxism

Minimum Eligible Age

20 Years

Maximum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes