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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT02889835
• Date of registration: 27/04/2016
• Prospective Registration: No
• Primary sponsor: 3M
• Public title: Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
• Scientific title: "Clinical Performance of an Incrementally Placed Highly Filled Composite, an Incrementally Placed Flowable Composite, and a Bulk Filled Composite in Class II Restorations"
• Date of first enrolment: March 22, 2016
• Target sample size: 53
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02889835
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Nathaniel Lawson, DDS
• Affiliation: University of Alabama at Birmingham

Key inclusion & exclusion criteria

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.



Age minimum: 19 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dental Caries

Intervention(s)

Device: Supreme Flowable Restorative

Device: Bulk Fill Flowable Restorative

Device: Supreme Universal Restorative

Primary Outcome(s)

Percent Acceptable Restorations [Time Frame: 36 Months]

Secondary Outcome(s)

Marginal Staining [Time Frame: 36 Months]

Tooth Integrity [Time Frame: 36 Month]

Surface Staining [Time Frame: 36 Month]

Recurrence of Caries, Erosion, Abfraction [Time Frame: 36 Months]

Proximal Contact Point [Time Frame: 36 Months]

Post-op Sensitivity [Time Frame: 36 Months]

Color Match [Time Frame: 36 Month]

Fracture of Material and Retention [Time Frame: 36 Month]

Occlusal Wear - Qualitative [Time Frame: 36 Month]

Patient's View [Time Frame: 36 Months]

Margin Adaptation [Time Frame: 36 Months]

Surface Luster [Time Frame: 36 Month]

Secondary ID(s)

CR16-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/09/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02889835