Clinical Performance of Injectable Universal Flowable Composite in Proximal Cavities of Posterior Teeth.

February 10, 2025 updated by: Nanees Ayman Hassan Aly, Cairo University

Clinical Performance of Injectable Universal Flowable Composite Versus Conventional Resin Composite Restorations in Proximal Cavities of Posterior Teeth.

The aim of the study is to evaluate the clinical performance of injectable universal flowable composite vs conventional resin composite restorations in proximal cavities of posterior teeth. The null hypothesis is proposed that there will be no difference in the clinical performance of injectable universal flowable composite versus conventional resin composite restorations in proximal cavities of posterior teeth. The design for this randomized controlled clinical trial is a superiority framework with parallel groups with equal allocation ratios. The patients are randomly divided into two groups where one group will receive conventional resin composite and the other group will receive injectable universal flowable resin composite. The restorations will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria at baseline, 3, 6, 12 month.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in conjunction with the Conservative Dentistry Department, Faculty of Dentistry, MSA University outpatient clinics. The predicted sample size was a total of 24. The sample size was increased by (20%) to account for possible dropouts during follow-up intervals to be total of (30) cases i.e. (15) for each group. Screening of patients that come to the Conservative Dentistry Department seeking dental care will continue until the target population is achieved. The patients will be subjected to examination and diagnosis. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research operator who will explain the study and ascertain the patients' interest. If interested, more detailed evaluations and preparations, and schedule planning will be made. Then the patient will sign the informed consent to ensure the approval for all the prosecuted that will be done and his/her acceptance to participate in this trial. Randomization will be done using simple randomization by computerized sequence generation using www.random.org by generating numbers from 1:30 into two columns. Each participant will choose a random number from an opaque sealed envelope. When the participant chooses an envelope, it will be signed by the patient and the supervisor and the number on the envelope will be recorded in the patient chart to ensure that the patient is assigned to the randomized group. After anesthesia, prophylaxis was performed using a brush associated with pumice, mounted in a low-speed handpiece. The teeth will be cleaned from any plaque or debris. After shade selection, rubber dam isolation will be used to avoid any moisture contamination which might affect the clinical performance of the bond and restoration, and to provide favorable conditions for bond application, if any reason is found that contraindicate rubber dam usage the procedure will be done under the cotton roll and high suction insulation and the use of retraction cord if needed to avoid any moisture contamination. The class II preparations will be made with spherical diamond burs of appropriate size and removal of carious dentine will be performed with spherical carbide bur at low-speed hand-piece and hand instruments. The cavities were designed according to the principles of minimally invasive dentistry. The outline shape of the preparations will be limited to the removal of caries. No bevels were prepared. Minor finishing and polishing may be done to the teeth if needed to remove any sharp edges or friable/undermined enamel. PALFIQUE BOND (Palfique, Tokuyama, Japan) will be used with both types of resin composites to ensure standardization of the procedures. It is a one-component, one-coat application, self-etching, light-cured, dental adhesive system. By using the disposable applicator, the bond will be applied on the surface of the prepared cavity and then wait for 10 seconds or more. Then mild air is continuously applied to the surface for 5 seconds until the runny bond stays in the same position without any movement and light-cured for 10 seconds. Injectable Universal flowable resin composite (PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan) super-low flowability supplied in L-syringe with nozzle and dispensing Tips. "Super Low" has low flowability, non-slumping, non-running, and precision stacking properties. The layer dispensed will be 2 mm. in thickness and cured for 40 s. Conventional resin composite (ESTELITE® Alpha; Tokuyama, Tokyo, Japan). The composite was inserted using the incremental technique. Incremental filling techniques result in better light penetration and better polymerization of the composite resin, reduction of the cavity configuration factor, cuspal deflection, polymerization shrinkage stresses; and ensures that the resin adheres better to cavity walls. Each increment of 2 mm was cured for 40 s.

The restoration was performed for both groups using a pre-curved metallic sectional matrix, associated with a separating ring and a wooden wedge.

Following the removal of the matrix band, the proximal regions of the restorations were additionally polymerized buccally and lingually/palatally for 10 s.

Occlusal adjustments were made using articulating paper, and the quality of the interproximal contacts and cervical adaptation was checked by means of dental floss and interproximal radiographs. The restorations were finished with water-cooled fine and super-fine diamond burs. The polishing procedures of the occlusal surface were performed with abrasive rubber tips during the same appointment immediately after the restorative procedure for both groups. All participants will be instructed to follow oral hygiene measures to avoid plaque and bacterial accumulation which may negatively affect the clinical performance as fracture or loss of retention. The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.

Study Type

Interventional

Enrollment (Actual)

30

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
      • Cairo, Egypt
        • Cairo 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Participant Inclusion Criteria

  • Adult patients aged 18-55 years.
  • Patients with good oral hygiene (mild to moderate plaque accumulation).
  • patients with asymptomatic compound proximal cavities in permanent posterior teeth.
  • ICDAS (3 &4)

Teeth inclusion criteria

  • Vital posterior teeth with compound proximal cavities.
  • Teeth with no or minimum mobility
  • No history of hypersensitivity in the teeth to be restored
  • Free from signs and symptoms of pulpitis and pulpal necrosis.

Participant Exclusion criteria

  • Patients who are unable to return for recall appointments.
  • Patients with poor oral hygiene.
  • Presence of abnormal oral, medical, or mental condition
  • Patients with untreated extra occlusal stresses
  • Patients with TMJ problems.

Teeth Exclusion criteria

  • Root involvement.
  • Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
  • Fractured or visibly cracked teeth.
  • Presence of any developmental or formative defects.

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: Intervention
Injectable Universal flowable resin composite
Other: PALFIQUE® Universal Flow; Tokuyama, Tokyo, Japan (super low flowability)
Supplied in L-syringe with nozzle and dispensing Tips. "Super Low" has low flowability, non-slumping, non-running, and precision stacking properties. The layer dispensed will be 2 mm. in thickness and cured for 40 s.
Other Names:
  • Injectable Universal flowable resin composite
Active Comparator: Control
Conventional resin composite
Other: ESTELITE® Alpha; Tokuyama, Tokyo, Japan
The composite was inserted using the incremental technique. Each increment of 2 mm was cured for 40 s.
Other Names:
  • Conventional resin composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Criteria of restoration evaluation indicating clinical performance.
Time Frame: 12 months
The restoration will be evaluated for any fracture or loss of retention by using prob following Modified USPHS criteria.
12 months

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2022

Primary Completion (Actual)

April 2, 2023

Study Completion (Actual)

April 2, 2023

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Universal flowable composite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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