Comparison of 2 Different Resin Based Filling Materials in Posterior Teeth - a Multicenter Study

Clinical Investigation of a New Nanohybrid Resin Composite Venus Pearl in Class 2 Cavities- a Multi-center Study

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.

Study Overview

• Status: Completed
• Conditions: Caries; Unsatisfactory or Defective Restoration of Tooth
• Intervention / Treatment: Device: Placement of restoration

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).

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Medical School Hannover
• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University-School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venus Pearl; Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.	Device: Placement of restoration; Placement of restorations
Active Comparator: control resin-based filling material; Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.	Device: Placement of restoration; Placement of restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score for Surface Luster	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface luster	2 years
Score for Surface Staining	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for surface staining	2 years
Score for Marginal Discoloration	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal discoloration	2 years
Score for Fracture and Retention	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for fracture and retention	2 years
Score for Color Match	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for color match	2 years
Score for Esthetic Anatomical Form	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of esthetic properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for esthetic anatomical form	2 years
Score for Marginal Adaptation	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for marginal adaptation	2 years
Score for Abrasion	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for abrasion	2 years
Score for Approximal Anatomical Form	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for approximal anatomical form	2 years
Score for Satisfaction of Patient	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of functional properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for satisfaction of patient	2 years
Score for Post-operative Hypersensitivity	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for post-operative hypersensitivity	2 years
Score for Caries, Erosion	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for caries, erosion	2 years
Score for "Tooth Integrity"	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for "tooth integrity"	2 years
Score for Parodontal Reaction	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for parodontal reaction	2 years
Score for Adjacent Mucosa	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters. Score of biological properties: 1: Clinically excellent, 2: Clinically good, 3: Clinically sufficient, 4: Clinically unsatisfactory, 5: Clinically poor Score for adjacent mucosa	2 years

Collaborators and Investigators

• Sponsor: Heraeus Kulzer GmbH
• Investigators: Study Chair: Werner Geurtsen, Prof. Dr., Hannover Medical School; Principal Investigator: Gabriela Ibarra, DDS, MPH, MS, Oregon Health and Science University; Principal Investigator: Werner Geurtsen, Prof. Dr., Medical School Hannover

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimated): August 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HKG-DT-01/2011-SOCO-CLIN