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

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925040
• Other study ID #: HKG-DT-01/2011-SOCO-CLIN
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: July 2022

Study information

• Verified date: August 2023
• Source: Heraeus Kulzer GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Unsatisfactory or Defective Restoration of Tooth

Intervention

Device:
• Placement of restoration
Placement of restorations

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover
United States	Oregon Health and Science University-School of Dentistry	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Heraeus Kulzer GmbH

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score	The primary endpoint will be a mean score calculated as following: There are three aspects to be assessed: aesthetic, functional attribute and biological parameters.	2 years