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Cavity, DentalNCT06461364

Clinical Performance of Bulk-fill Restorations in Class II Cavities

A study testing Assessment of cuspal deflection of bulk-fill restorations in people with Cavity, Dental, run by Egymedicalpedia at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics. These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries, crown fractures, tooth wear, and congenital defects. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Cavity, Dental
What is being tested?
Assessment of cuspal deflection of bulk-fill restorations
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
20 Jul 2022to 25 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients included in the study must be with at least two proximal caries teeth of ICDAS score 4.
  • Patients with moderate and high caries risk index.
  • Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures.
  • At least two permanent molars at one side requiring class ii caries lesions, with at least one neighboring tooth and in occlusion with antagonistic teeth.
  • Moderate to large size cavities that extended into dentine, while maintain natural tooth contour.
  • Absence of tooth mobility, tenderness, severe pain or pre-operative sensitivity.
  • Normal occlusion relation with normal dentition

Who cannot join

  • Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
  • Developmental disorders and adjacent soft tissue lesions.
  • Patients with systemic illness will be excluded

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistary - Al-Azhar University

    Cairo

Other trials in Egypt

About this study

Official title: Evaluation of Cuspal Deflection and Fracture Resistance of Different Bulk-fill Restorations and Their Clinical Performance in Class II Cavities

Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics. These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries, crown fractures, tooth wear, and congenital defects.

Read the detailed description

It has been reported that the polymerization shrinkage and its associated contraction stress are the greatest limitation in the use of resin-based composite (RBC) as a restorative material for posterior teeth.

Shrinkage stress that is generated due to the polymerization reaction is known as a multifaceted complicated condition. There are many factors aiding to development of the rate of shrinkage stress such as material formulation, degree of conversion, polymerization kinetics, flow capacity in the early stages of the curing reaction, and elastic modulus of the material itself.

Shrinkage stress appear in the form of several manifestations as cuspal movement which can result in enamel micro cracks, cervical marginal gaps, creating postoperative sensitivity, discoloration of the margins, recurrent caries, breakages of the restoration and finally replacement of composite restorations.

New types of restorative materials called bulk-fill restorative materials have been introduced to reduce time required for placement. These materials can be placed in bulk layer up to 4-5mm with adequate polymerization and low polymerization shrinkage stress. However, little information is available regarding the effect of these restorative materials on cuspal deflection.

The first thermoviscous bulk-fill composite, has the viscosity of a flowable composite and the sculptability of a packable composite all in a single material. Prior to placement, this material is warmed in a modified caps warmer. Bulk-fil composite satisfies the sealing of the proximal box as well as attains the desired anatomy in a single bulk-cure product in class II restorations.

Cuspal deflection is a common biomechanical phenomenon that occurs in teeth restored with composite resin-based materials and represents the interaction between polymerization stress of material and the compliance of remaining tooth structure, which may cause failure during composite curing or act as a preloading, facilitating tooth fracture under occlusal loads. Cuspal deflection can be perceived clinically by the patient as postoperative sensitivity.

The fracture of teeth is a common dental problem. Many factors such as tooth anatomy contribute to cusp fracture; however, cavity preparation procedures seem to be the major cause of most cuspal fractures. Posterior teeth, particularly premolars, have an anatomic shape that makes them more likely to fracture under occlusal load, whereas sound teeth are rarely fracture under normal masticatory function. Several studies have emphasized the importance of maintaining dental structure to preserve the strength of remaining tooth. Generally, the wider the involvement by caries or cavity preparation, the weaker the tooth.

The FDI criteria-based proposal allows to classify the evaluation of dental restorations, according to functional, biological and aesthetic categories. Their use was thus recommended in clinical trials assessing dental restorations in terms of materials, operative technique/intervention, as well as in clinical practice to determine whether a restoration should be maintained, repaired or replaced. One study compared the FDI criteria and the traditional United States Public Health Service (USPHS; also known as 'Ryge criteria') criteria for the evaluation of dental restorations.

Conditions
Cavity, Dental
Being tested
Assessment of cuspal deflection of bulk-fill restorations
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of cuspal deflection of bulk-fill restorationsProcedure or surgery

    To assess the performance of bulk-fill restorations on premolar teeth in class II cavities using some selected FDI criteria, a total sample size of 30 (10 for each group test) will be sufficient to detect: an effect size of 1.22 at a power (1-β error) of 0.8 and using a two-sided hypothesis test and a significance level (α error) 0.05 for data. Two teeth will be added to each group to compensate drop out samples.

Study groups in NCT06461364
Study groupRoleWhat they receive
Group AExperimentalAbout 10 participants faced Self-adhesive composite (Surefil one)
Receives: Procedure: Assessment of cuspal deflection of bulk-fill restorations
Group BExperimentalAbout 10 participants faced Viscalor
Receives: Procedure: Assessment of cuspal deflection of bulk-fill restorations
Group CExperimentalAbout 10 participants faced Equiaforte
Receives: Procedure: Assessment of cuspal deflection of bulk-fill restorations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FDI criteria Esthetic

    evaluated surface luster and surface staining

    Measured: from 3 months to 12 months

  2. FDI criteria Functional

    evaluated fracture of material and retention,occlusal contour and wear

    Measured: from 3 months to 12 months

  3. FDI criteria Biological

    Biological evaluated post operative hypersensitivity and recurrence caries

    Measured: from 3 months to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start20 Jul 2022
  3. Primary completion20 Jul 2023
  4. Study completion25 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461364
Sponsor's protocol ID
Walaa Hassan
Status last verified
Jun 2024
First submitted
9 Jun 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Assessment of cuspal deflection of bulk-fill restorations in people with Cavity, Dental, run by Egymedicalpedia at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FDI criteria Esthetic (time frame: from 3 months to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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