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.
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.
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 group | Role | What they receive |
|---|---|---|
| Group A | Experimental | About 10 participants faced Self-adhesive composite (Surefil one) Receives: Procedure: Assessment of cuspal deflection of bulk-fill restorations |
| Group B | Experimental | About 10 participants faced Viscalor Receives: Procedure: Assessment of cuspal deflection of bulk-fill restorations |
| Group C | Experimental | About 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.
FDI criteria Esthetic
evaluated surface luster and surface staining
Measured: from 3 months to 12 months
FDI criteria Functional
evaluated fracture of material and retention,occlusal contour and wear
Measured: from 3 months to 12 months
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.
- First posted17 Jun 2024
- Study start20 Jul 2022
- Primary completion20 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavity, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
- Investigators
- Wael Essam Jamil, Professor, Study chair, Al-Azhar Faculty of Dentistary for girls
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cuspal Deflection and Fracture Resistance of Different Bulk-fill Restorations and Their Clinical Performance in Class II Cavities
- ClinicalTrials.gov ID
- NCT06461364
- Acronym / sponsor ID
- Walaa Hassan
- Conditions
- Cavity, Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Assessment of cuspal deflection of bulk-fill restorationsAbout 10 participants faced Self-adhesive composite (Surefil one) |
| Group B | Experimental | Procedure: Assessment of cuspal deflection of bulk-fill restorationsAbout 10 participants faced Viscalor |
| Group C | Experimental | Procedure: Assessment of cuspal deflection of bulk-fill restorationsAbout 10 participants faced Equiaforte |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of cuspal deflection of bulk-fill restorationsTo 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. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
FDI criteria Esthetic
Time frame: from 3 months to 12 months
evaluated surface luster and surface staining
FDI criteria Functional
Time frame: from 3 months to 12 months
evaluated fracture of material and retention,occlusal contour and wear
FDI criteria Biological
Time frame: from 3 months to 12 months
Biological evaluated post operative hypersensitivity and recurrence caries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael Essam Jamil, Professor study chair
Al-Azhar Faculty of Dentistary for girls
1 site in 1 country: see every site and its status.
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.