Bulk-fill With Different Technique Three-year Clinical Performance

May 16, 2023 updated by: Mansoura University

Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation

The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Daqahlia
      • El Mansura, Daqahlia, Egypt, 0000
        • Operative Department, Faculty of Dentistry, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good general health
  • Good oral hygienic
  • Patient aging 18-35 year
  • Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
  • Carious lesion in the external and middle third of dentin thickness
  • ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
  • Maxillary or mandibular first or second molars
  • Tooth with antagonist and adjacent mesial and distal tooth contact,
  • Normal response to a vitality test.

Exclusion Criteria:

  • Poor oral hygiene
  • Severe or chronic periodontitis
  • Heavy bruxism
  • Occlusion fewer than 20 teeth
  • Sensitivity to resin-based material.
  • Patients with orthodontic treatment
  • Patients on pregnancy or lactation
  • chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
  • Patient potentially unable to attend recall visits
  • Teeth would need direct pulp capping or
  • Teeth act as abutment for fixed or removable prosthesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Body Bulk-Fill
20 cavity class II restored with Body bulk-fill Resin composite
Other: Filtek™ Bulk Fill restoration
restoration of class II caries with different bulk-fill technique
Experimental: preheated Bulk-Fill
20 cavity class II restored with preheated bulk-fill Resin composite
Other: Heated Filtek™ Bulk Fill restoration
restoration of class II caries with different bulk-fill technique
Experimental: Injectable Bulk-Fill
20 cavity class II restored with injectable bulk-fill Resin composite
Other: G-aenial™ BULK Injectable restoration
restoration of class II caries with different bulk-fill technique
Experimental: Sonic-Fill
20 cavity class II restored with sonic-fill bulk-fill Resin composite
Other: Sonicfill3 restoration
restoration of class II caries with different bulk-fill technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Esthetic Properties of restorations
Time Frame: Three years Follow up

criteria that evaluated according to Modified FDI(International Dental Federation) world dental federation is:

  1. Surface luster
  2. Staining
  3. Color match and translucency
  4. Esthetic and Anatomic form

Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Three years Follow up
Functional Properties of restorations
Time Frame: Three years Follow up

criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is:

  1. Fractures of material and retention
  2. Marginal adaptation
  3. Occlusal contour and wear
  4. Proximal anatomical form
  5. Patient's view

Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Three years Follow up
Biological Properties of restorations
Time Frame: Three years Follow up

criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is:

  1. Post-operative (hyper-sensitivity) and tooth vitality
  2. Recurrence of caries, erosion, abfraction
  3. Tooth integrity (enamel cracks, tooth fractures)
  4. Periodontal
  5. Adjacent Mucosa
  6. Oral and General Health

Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor
Three years Follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M01060421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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