Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy (NCT03221660) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Liechtenstein50 participantsStarted 2018-01-11
Plain-language summary
The objective of this study is to evaluate the clinical performance of F-Composite 2 system in Class I and Class II cavities in permanent teeth.
The materials of the system can be polymerized in short time with a curing light which is part of the system.
The study will be carried out as a prospective study, with evaluation of the restorations after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according to defined criteria.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Indication for direct filling of Class I or II with permanent premolars or permanent molars
* replacement of insufficient fillings (e.g., due to edge caries, filling fracture, Lack of quality of the surface, lack of aesthetics, undesirable filling material, leaky edge, edge gap, etc.)
* extensive primary caries
* Vital tooth (cold test)
* One-, two- or three-surface fillings in the lateral tooth area, with a maximum of 25% single-faced (Class I) with antagonists.
* The occlusal area of the filling must be at least 1/3 of the total area of the filling tooth. This criterion is estimated.
* Patient wishes to receive care within the framework of the study (written consent after detailed elucidation and study of patient information).
* Maximum of 2 restorations per patient.
* Preoperative complaints on the tooth to be restored (maximum 3 on visual Analog scale (0 = complaint-free, 10 = maximum possible pain) to temperature or bite sensitivity
* Sufficient language skills
Exclusion Criteria:
* Unfinished hygiene phase or poor oral hygiene
* Sufficient draining of the operating field is not possible
* Patients with proven allergy to one of the ingredients of the materials used
* Patient has allergies to local anesthetic agents Ultracain DS (active substance: articaine; Vasoconstrictor), if anesthesia is desired
* Patients with severe systemic diseases
* Devital or pulpitic teeth
* Periodontal insufficiency
* Supplements with cusp attachments
* open side bite…
What they're measuring
1
Percentage of Restored Teeth With Postoperative Sensitivity