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.
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
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
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 group | Role | What they receive |
|---|---|---|
| Universal Composite | Active comparator | Supreme Universal Restorative Receives: Device: Supreme Universal Restorative |
| Flowable Composite | Experimental | Supreme Flowable Restorative Receives: Device: Supreme Flowable Restorative |
| Bulk Fill Flowable Composite | Experimental | Bulk 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.
Percent Acceptable Restorations
Percentage of restorations that survived (percent clinically acceptable per FDI criteria) over 36 months.
Measured: 36 Months
Secondary outcomes (12)
Surface Luster
- Luster comparable to enamel
- Slightly dull, not noticeable from speaking distance.
- Surface is dull but still acceptable if the surface of the restoration is covered with a film of saliva.
- Surface is rough and not masked by salivary film. Major re-finishing or veneering is necessary and possible.
- 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
Surface Staining
- No surface staining.
- 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.
- Moderate surface staining not noticeable from a speaking distance.
- 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.
- Surface staining is totally unacceptable/unsightly and the restoration needs to be replaced.
Measured: 36 Month
Color Match
- 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.
- Colour match is clinically acceptable but minor deviations in shade between tooth and restoration are apparent.
- Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.
- Colour match is satisfactory; there is a clear deviation in colour match that does not affect aesthetics.
- 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
Fracture of Material and Retention
- No fractures / cracks.
- Small hairline crack.
- Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact.
- Material chip fractures which damage marginal quality or approximal contacts.
- Bulk fractures with partial loss (less than half of the restoration).
Measured: 36 Month
Occlusal Wear - Qualitative
- Physiological wear equivalent to enamel.
- Normal wear only slightly different from that of enamel.
- Different wear rate than enamel but within the biological variation.
- Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.
- Wear considerably exceeds normal enamel wear; or occlusal contact points are lost.
Measured: 36 Month
Tooth Integrity
- Complete integrity.
- Small marginal enamel fracture (<150 µm) / Hairline crack in enamel (<150 µm)
- Marginal enamel defect <250µm / Crack <250µm / Enamel chipping
- Multiple cracks / Major marginal enamel defects; gap > 250 µm or dentine or base exposed
- Cusp or tooth fracture
Measured: 36 Month
Recurrence of Caries, Erosion, Abfraction
- No secondary or primary caries
- Small and localized: Demineralization / Erosion / Abfraction.
- Larger areas of: Demineralisation / Erosion / Abrasion / abfraction, dentine not exposed. Only preventive measures necessary
- Caries with cavitation and suspected undermining caries / Erosion in dentine / Abrasion, abfraction in dentine. Localized and accessible can be repaired.
- Deep caries or exposed dentine that is not accessible for repair of restoration
Measured: 36 Months
Margin Adaptation
- No clinically detectable gap.
- Marginal integrity deviates from ideal but could be upgraded to ideal by polishing.
- 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.
- Localized gap larger than 250 µm, may result in exposure of dentine or base. Repair necessary for prophylactic reasons.
- 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
Marginal Staining
- No marginal staining
- Minor marginal staining, easily removable.
- Moderate marginal staining, not aesthetically unacceptable.
- Pronounced (mainly localized) marginal staining and not removable by polishing; major intervention necessary for improvement. of aesthetics
- Deep marginal staining (generalized and/or profound), not accessible for intervention.
Measured: 36 Months
Proximal Contact Point
- Contact is physiological (dental floss can only be inserted into the interdental space under pressure).
- Contact is slightly too strong but acceptable. Floss or 25 µm metal blade can only be passed through contact with force/pressure.
- 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.
- 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.
- 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
Patient's View
- Entirely satisfied with aesthetics and function
- Satisfied with aesthetics and function
- Minor criticism but no adverse clinical effects.
- Desire for improvement (aesthetics / function); Reshaping of anatomic form or refurbishing is possible.
- Completely dissatisfied and / or adverse effects, incl. pain
Measured: 36 Months
Post-op Sensitivity
- No postoperative hypersensitivity. Normal pulp vitality response.
- 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).
- Intense postoperative hypersensitivity of duration greater than one week but less than six-months.
- 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.
- 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.
22 Mar 20163 Jul 2021
- First posted7 Sep 2016 (estimated)
- Study start22 Mar 2016
- Primary completion3 Jul 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Nathaniel Lawson, DDS, Principal investigator, University of Alabama at Birmingham
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No