Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations

September 27, 2024 updated by: Solventum US LLC

"Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"

This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).

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.
53

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-2005
        • University of Alabama at Birmingham Dental School

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

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • must have given written informed consent to participate in the trial
  • must need at least three posterior dental fillings
  • replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
  • must be available for the required post-operative follow-up visits
  • restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
  • Class II restorations must have at least one proximal contact
  • restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
  • all restorations must Class II with a proximal contact with a natural or artificial tooth

Exclusion Criteria:

  • have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
  • have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
  • have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
  • are unavailable for long term recall
  • cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
  • do not meet all inclusion criteria
  • present with any systemic or local disorders that contra-indicate the dental procedures included in this study
  • have an unstable occlusion
  • have severe bruxing or clenching or in need of TMJ related therapy
  • have teeth with periapical pathology or expected pulp exposures
  • have teeth that are non-vital or that exhibit signs of pulpal pathology
  • are pregnant.

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: Single Group Assignment
  • Masking: Single

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.
Active Comparator: Universal Composite
Supreme Universal Restorative
Device: Supreme Universal Restorative
Experimental: Flowable Composite
Supreme Flowable Restorative
Device: Supreme Flowable Restorative
Experimental: Bulk Fill Flowable Composite
Bulk Fill Flowable Restorative
Device: Bulk Fill Flowable Restorative

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
Percent Acceptable Restorations
Time Frame: 36 Months
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
36 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surface Luster
Time Frame: 36 Month
  1. Luster comparable to enamel
  2. Slightly dull, not noticeable from speaking distance.
  3. Surface is dull but still acceptable if the surface of the restoration is covered with a film of saliva.
  4. Surface is rough and not masked by salivary film. Major re-finishing or veneering is necessary and possible.
  5. Surface is unacceptably rough which makes it ugly and/or it retains noticeable biofilm (plaque). Improvement by finishing or veneering is not feasible.
36 Month
Surface Staining
Time Frame: 36 Month
  1. No surface staining.
  2. Minor surface staining (under dry conditions) is present but is evenly spread over all the teeth. It does not affect the aesthetic properties because it is generalized and acceptable.
  3. Moderate surface staining not noticeable from a speaking distance.
  4. Surface staining is present on the restoration but not the tooth and is clearly recognizable from a speaking distance. The aesthetic properties of the dentition are affected. Restoration requires major correction and layering of new material.
  5. Surface staining is totally unacceptable/unsightly and the restoration needs to be replaced.
36 Month
Color Match
Time Frame: 36 Month
  1. Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel and adjacent teeth. There is no difference in shade, brightness or translucency between restoration and tooth.
  2. Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent.
  3. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.
  4. Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.
  5. Colour match and/or translucency are clinically unsatisfactory. The restoration displays an unacceptable alteration in colour and/or translucency. Restoration needs replacement.
36 Month
Fracture of Material and Retention
Time Frame: 36 Month
  1. No fractures / cracks.
  2. Small hairline crack.
  3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact.
  4. Material chip fractures which damage marginal quality or approximal contacts.
  5. Bulk fractures with partial loss (less than half of the restoration).
36 Month
Occlusal Wear - Qualitative
Time Frame: 36 Month
  1. Physiological wear equivalent to enamel.
  2. Normal wear only slightly different from that of enamel.
  3. Different wear rate than enamel but within the biological variation.
  4. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.
  5. Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.
36 Month
Tooth Integrity
Time Frame: 36 Month
  1. Complete integrity.
  2. Small marginal enamel fracture (<150 µm) / Hairline crack in enamel (<150 µm)
  3. Marginal enamel defect <250µm / Crack <250µm / Enamel chipping
  4. Multiple cracks / Major marginal enamel defects; gap > 250 µm or dentine or base exposed
  5. Cusp or tooth fracture
36 Month
Recurrence of Caries, Erosion, Abfraction
Time Frame: 36 Months
  1. No secondary or primary caries
  2. Small and localized: Demineralization / Erosion / Abfraction.
  3. Larger areas of: Demineralisation / Erosion / Abrasion / abfraction, dentine not exposed. Only preventive measures necessary
  4. Caries with cavitation and suspected undermining caries / Erosion in dentine / Abrasion, abfraction in dentine. Localized and accessible can be repaired.
  5. Deep caries or exposed dentine that is not accessible for repair of restoration
36 Months
Margin Adaptation
Time Frame: 36 Months
  1. No clinically detectable gap.
  2. Marginal integrity deviates from ideal but could be upgraded to ideal by polishing.
  3. Leakage/discoloration is present but limited to border area of margins. Generalized marginal gap >150 µm but <250 µm, easily perceptible on probing but cannot be modified without minor damage to tooth or surrounding tissue, and is not considered to result in long-term negative consequences for tooth or surrounding tissue if left untreated. Presence of several small marginal fractures that are unlikely to cause long-term effects.
  4. Localized gap larger than 250 µm, may result in exposure of dentine or base. Repair necessary for prophylactic reasons.
  5. Generalized gap larger than 250 µm or restoration is loose but in situ, replacement necessary or large fractures at margins and loss of material is too extensive to be repaired.
36 Months
Marginal Staining
Time Frame: 36 Months
  1. No marginal staining
  2. Minor marginal staining, easily removable.
  3. Moderate marginal staining, not aesthetically unacceptable.
  4. Pronounced (mainly localized) marginal staining and not removable by polishing; major intervention necessary for improvement. of aesthetics
  5. Deep marginal staining (generalized and/or profound), not accessible for intervention.
36 Months
Proximal Contact Point
Time Frame: 36 Months
  1. Contact is physiological (dental floss can only be inserted into the interdental space under pressure).
  2. Contact is slightly too strong but acceptable. Floss or 25 µm metal blade can only be passed through contact with force/pressure.
  3. Contact is weak, a 50 µm metal blade can pass through contact area but not a 100 µm blade, or floss passes very easily with only a slight snap effect. There is no indication for removing/repairing restoration and there is no damage to tooth, gingiva or other periodontal structures. There is no cervical caries, inflammation of the gingival papilla through food impaction, or pocket formation.
  4. Contact is weak and a 100 µm metal blade can easily pass through. In addition there are signs of damage to tooth (i.e. cervical caries,). Repair is necessary.
  5. Contact is weak allowing damage due to food impaction and demonstrating pain/gingivitis requires immediate intervention. Repair is not feasible and replacement is necessary.
36 Months
Patient's View
Time Frame: 36 Months
  1. Entirely satisfied with aesthetics and function
  2. Satisfied with aesthetics and function
  3. Minor criticism but no adverse clinical effects.
  4. Desire for improvement (aesthetics / function); Reshaping of anatomic form or refurbishing is possible.
  5. Completely dissatisfied and / or adverse effects, incl. pain
36 Months
Post-op Sensitivity
Time Frame: 36 Months
  1. No postoperative hypersensitivity. Normal pulp vitality response.
  2. Postoperative hypersensitivity of short duration (less than one week) and no longer present at the baseline assessment. Pulp vitality response normal at baseline assessment (one week after placement).
  3. Intense postoperative hypersensitivity of duration greater than one week but less than six-months.
  4. Persistent postoperative hypersensitivity. Response to cold stimulus is markedly premature/strong and major intervention is necessary; or there is extremely delayed/weak and unclear or negative sensitivity. Sensitivity level is significantly different from the situation prior to treatment.
  5. Negative sensitivity recorded at recall visit despite positive pulp response at baseline, or severe pain is noted. Removal of restoration and immediate root canal treatment is required or the tooth must be extracted.
36 Months

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.
Solventum US LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
3M

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathaniel Lawson, DDS, University of Alabama at Birmingham

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.
March 22, 2016

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.
July 3, 2021

Study Completion (Actual)

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.
July 3, 2021

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).
April 27, 2016

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.
August 31, 2016

First Posted (Estimated)

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.
September 7, 2016

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.
October 1, 2024

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.
September 27, 2024

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.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • CR16-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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