Clinical trial NCT01925040: Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study
Official title: Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Unsatisfactory or Defective Restoration of Tooth
Lead sponsor: Heraeus Kulzer GmbH
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of a new resin based filling material to an established resin-based filling material in posterior teeth at 2 different study centers.

Detailed description: The objective of this study is to compare the performance of the composite resin Venus Pearl and a commercially available control composite material for the restoration of class II-cavities. Primary endpoints of the study are a mean score for each patient calculated from aesthetic, functional attribute and biological parameters. Secondary endpoints are the evaluation of secondary caries, plaque accumulation and gingival reactions and the comparison of the primary score at week 1, month 6, month 12 and month 24 after restoration. Beside this, the single components of the three categories of the primary endpoints will be compared. The study will be executed as a multi-center (Oregon Health \& Science University, Portland, OR, USA and Medical School Hannover, Hannover, Germany), single-blinded and randomized clinical investigation. 90 comparable cavities per study site will be treated (45 cavities for each material at each site).

Eligibility criteria: Inclusion Criteria:

* Patients should be 18 years and older.
* Study teeth should have an interproximal (Class II) carious lesion or an existing defective class II restoration requiring restorative therapy on premolars or molars.
* The maximum cavity depth determined by the radiograph will be D2 (Tyas classification).
* The teeth included in the study need to have a proximal contact with the adjacent tooth and be in occlusion with the opposing dentition.
* The teeth included in the study should be vital with no signs of pulpal pathology.
* Patients that report brushing regularly without severe gingival inflammation and/or extensive caries.
* Patients should have no allergies or systemic diseases which inhibit the treatment.
* Patients should have voluntary participation and sign a written informed consent form.
* Patients should be willing to participate in the recall/re-examination appointments.

Exclusion Criteria:

* Simultaneous participation in another study about dental restorative materials.
* Written informed consent form not signed.
* Nonvital pulp / periapical lesion.
* Insufficient oral hygiene despite detailed instructions.
* Pregnancy/ breast feeding before placement of the study restoration.
* Minors.
* Severe malocclusion/ malalignment/ traumatic occlusion/ bruxism.
* Known allergy to any components present in any of the materials that are used for this study.
* Unclear mucosal alterations, e.g. oral lichenoid reactions/lesions.
* Severe medical complications (organ transplants, cancer, immune-compromised, long-term antibiotic or steroid therapy).
* Infectious diseases such as HIV/Aids, Hepatitis, etc.
* Application of bleaching products less than 14 days before placement of the restoration.
* Orthodontic treatment during the study.
* Xerostomia.
* Untreated periodontal diseases.
* Rampant or extensive caries present.
* Systemic diseases with potential oral manifestation.
* Sufficient isolation according to the criteria of adhesive techniques not possible, e.g. application of rubber dam.
* Direct adhesive restoration not indicated.
* Replacement of more than one cusp indicated.
* Dental fears patients.

Primary outcomes:
measure: Score for Surface Luster
timeFrame: 2 years
measure: Score for Surface Staining
timeFrame: 2 years
measure: Score for Marginal Discoloration
timeFrame: 2 years
measure: Score for Fracture and Retention
timeFrame: 2 years
measure: Score for Color Match
timeFrame: 2 years
measure: Score for Esthetic Anatomical Form
timeFrame: 2 years
measure: Score for Marginal Adaptation
timeFrame: 2 years
measure: Score for Abrasion
timeFrame: 2 years
measure: Score for Approximal Anatomical Form
timeFrame: 2 years
measure: Score for Satisfaction of Patient
timeFrame: 2 years
measure: Score for Post-operative Hypersensitivity
timeFrame: 2 years
measure: Score for Caries, Erosion
timeFrame: 2 years
measure: Score for "Tooth Integrity"
timeFrame: 2 years
measure: Score for Parodontal Reaction
timeFrame: 2 years
measure: Score for Adjacent Mucosa
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University-School of Dentistry
state: Oregon
city: Hannover
country: Germany
facility: Medical School Hannover
Study officials:
affiliation: Hannover Medical School
name: Werner Geurtsen, Prof. Dr.
role: STUDY_CHAIR
affiliation: Oregon Health and Science University
name: Gabriela Ibarra, DDS, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School Hannover
name: Werner Geurtsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: