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Dental CariesNCT02889835

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

A study testing Supreme Universal Restorative, Supreme Flowable Restorative and Bulk Fill Flowable Restorative in people with Dental Caries, run by Solventum US LLC at 1 site in United States.

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

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. Read more about this study

Who is it for?
Ages 19 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Supreme Universal Restorative, Supreme Flowable Restorative and Bulk Fill Flowable Restorative
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
22 Mar 2016to 3 Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham Dental School

    Birmingham, Alabama, 35233-2005

Other trials in United States

About this study

Official title: "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.

Read the 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).

Conditions
Dental Caries
Being tested
Supreme Universal Restorative, Supreme Flowable Restorative, Bulk Fill Flowable Restorative
Keywords
Class II, molar and premolar, resin composite, adult, restoration
Medical subject headings
Dental Caries, Bicuspid Aortic Valve Disease

What participants receive

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

  • Supreme Universal RestorativeDevice

  • Supreme Flowable RestorativeDevice

  • Bulk Fill Flowable RestorativeDevice

Study groups in NCT02889835
Study groupRoleWhat they receive
Universal CompositeActive comparatorSupreme Universal Restorative
Receives: Device: Supreme Universal Restorative
Flowable CompositeExperimentalSupreme Flowable Restorative
Receives: Device: Supreme Flowable Restorative
Bulk Fill Flowable CompositeExperimentalBulk Fill Flowable Restorative
Receives: Device: Bulk Fill Flowable Restorative

What is being measured

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

  1. Percent Acceptable Restorations

    Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.

    Measured: 36 Months

Secondary outcomes (12)

  1. Surface Luster

    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.

    Measured: 36 Month

  2. Surface Staining

    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.

    Measured: 36 Month

  3. Color Match

    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.

    Measured: 36 Month

  4. Fracture of Material and Retention

    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).

    Measured: 36 Month

  5. Occlusal Wear - Qualitative

    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.

    Measured: 36 Month

  6. Tooth Integrity

    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

    Measured: 36 Month

  7. Recurrence of Caries, Erosion, Abfraction

    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

    Measured: 36 Months

  8. Margin Adaptation

    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.

    Measured: 36 Months

  9. Marginal Staining

    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.

    Measured: 36 Months

  10. Proximal Contact Point

    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.

    Measured: 36 Months

  11. Patient's View

    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

    Measured: 36 Months

  12. Post-op Sensitivity

    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.

    Measured: 36 Months

Timeline

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

  1. First posted7 Sep 2016 (estimated)
  2. Study start22 Mar 2016
  3. Primary completion3 Jul 2021
  4. Study completion3 Jul 2021

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
Single group
Model description
Single group with a split mouth design in which each subject received all three treatments. Of the 53 total subjects, 3 study subjects actually received duplicate treatment, i.e., they received 6 dental restorations.
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02889835
Sponsor's protocol ID
CR16-005
Status last verified
Sep 2024
First submitted
27 Apr 2016
Last updated
1 Oct 2024
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Supreme Universal Restorative, Supreme Flowable Restorative and Bulk Fill Flowable Restorative in people with Dental Caries, run by Solventum US LLC at 1 site in United States.

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 8 inclusion and 12 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 1 Oct 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 United States. 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?

Yes. Results are posted in the registry (first posted 11 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Acceptable Restorations (time frame: 36 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02889835.

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 1 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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