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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • 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

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
Intervention / Treatment
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

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

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)

May 9, 2021

Primary Completion (Actual)

May 9, 2022

Study Completion (Anticipated)

May 9, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID 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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