Clinical trial NCT02889835: Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Class II
molar and premolar
resin composite
adult
restoration
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2016-09-07
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility 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.

Primary outcomes:
measure: Percent Acceptable Restorations
timeFrame: 36 Months
Secondary outcomes:
measure: Surface Luster
timeFrame: 36 Month
measure: Surface Staining
timeFrame: 36 Month
measure: Color Match
timeFrame: 36 Month
measure: Fracture of Material and Retention
timeFrame: 36 Month
measure: Occlusal Wear - Qualitative
timeFrame: 36 Month
measure: Tooth Integrity
timeFrame: 36 Month
measure: Recurrence of Caries, Erosion, Abfraction
timeFrame: 36 Months
measure: Margin Adaptation
timeFrame: 36 Months
measure: Marginal Staining
timeFrame: 36 Months
measure: Proximal Contact Point
timeFrame: 36 Months
measure: Patient's View
timeFrame: 36 Months
measure: Post-op Sensitivity
timeFrame: 36 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Dental School
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Nathaniel Lawson, DDS
role: PRINCIPAL_INVESTIGATOR
References: