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

NCT01925040 | Completed Results

• 1 other identifier: HKG-DT-01/2011-SOCO-CLIN
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 2

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.

Conditions

Caries; Unsatisfactory or Defective Restoration of Tooth

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Venus Pearl

EXPERIMENTAL

Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.

Device: Placement of restoration

control resin-based filling material

ACTIVE COMPARATOR

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

Interventions

Placement of restoration DEVICE

Placement of restorations

Venus Pearl; control resin-based filling material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heraeus Kulzer GmbH: lead

Study Sites (2)

Oregon Health and Science University-School of Dentistry

Portland, Oregon, 97239, United States

Location

Medical School Hannover

Hanover, 30625, Germany

Location

Results Point of Contact

• Title: Global Scientific Affairs Management
• Organization: Kulzer GmbH

andrea.leyer@kulzer-dental.com

+4915116891006

Study Officials

• Werner Geurtsen, Prof. Dr.

  Hannover Medical School

  STUDY CHAIR

• Gabriela Ibarra, DDS, MPH, MS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Werner Geurtsen, Prof. Dr.

  Medical School Hannover

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Locations

US (1); DE (1)