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

Not Applicable

Completed

Conditions: Caries
Unsatisfactory or Defective Restoration of Tooth

Interventions: Device: Placement of restoration

Registration Number: NCT01925040

Lead Sponsor: Heraeus Kulzer GmbH

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venus Pearl	Placement of restoration	Placement of restoration using Venus Pearl in carious teeth or as a replacement of a defective previous restoration.
control resin-based filling material	Placement of restoration	Placement of restoration using a control resin-based filling material in carious teeth or as a replacement of a defective previous restoration.

Primary Outcome Measures

Name	Time	Method
Score for Surface Luster	2 years	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
Score for Surface Staining	2 years	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
Score for Marginal Discoloration	2 years	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
Score for Fracture and Retention	2 years	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
Score for Color Match	2 years	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
Score for Esthetic Anatomical Form	2 years	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
Score for Marginal Adaptation	2 years	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
Score for Abrasion	2 years	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
Score for Approximal Anatomical Form	2 years	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
Score for Satisfaction of Patient	2 years	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
Score for Post-operative Hypersensitivity	2 years	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
Score for Caries, Erosion	2 years	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
Score for "Tooth Integrity"	2 years	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"
Score for Parodontal Reaction	2 years	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
Score for Adjacent Mucosa	2 years	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Oregon Health and Science University-School of Dentistry
🇺🇸
Portland, Oregon, United States
Medical School Hannover
🇩🇪
Hannover, Germany