N/A N=168 Randomized Single-blind Treatment

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

Caries · Unsatisfactory or Defective Restoration of Tooth

Bottom Line

View on ClinicalTrials.gov: NCT01925040 ↗

Enrolled (actual)

168

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Score for Surface Luster — 1.89; 1.62 scores on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Placement of restoration (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Heraeus Kulzer GmbH
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Score for Surface Luster	1.89; 1.62	—
PRIMARY Score for Surface Staining	1.44; 1.34	—
PRIMARY Score for Marginal Discoloration	1.49; 1.47	—
PRIMARY Score for Fracture and Retention	1.24; 1.32	—
PRIMARY Score for Color Match	1.64; 1.64	—
PRIMARY Score for Esthetic Anatomical Form	1.49; 1.45	—
PRIMARY Score for Marginal Adaptation	1.29; 1.42	—
PRIMARY Score for Abrasion	1.16; 1.17	—
PRIMARY Score for Approximal Anatomical Form	1.44; 1.23	—
PRIMARY Score for Satisfaction of Patient	1.04; 1.06	—
PRIMARY Score for Post-operative Hypersensitivity	1.04; 1.04	—
PRIMARY Score for Caries, Erosion	1.02; 1.08	—
PRIMARY Score for "Tooth Integrity"	1.11; 1.19	—
PRIMARY Score for Parodontal Reaction	1.45; 1.36	—
PRIMARY Score for Adjacent Mucosa	1.07; 1.11	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01925040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.