Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy (NCT04475679) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy
Stopped: not sufficient cases for recall to investigate performance of test product
Liechtenstein80 participantsStarted 2020-09-14
Plain-language summary
A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for molars and premolars will be luted with Adhese Universal DC or Adhese Universal.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18-65 years
* Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
* 2-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
* Max. 2 restorations per participant in different quadrants.
* Vital tooth
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills
Exclusion Criteria:
* Sufficient isolation not possible, dry working field cannot be guaranteed
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Nonvital tooth or tooth with irreversible pulpitis
* Indication for direct pulp capping
* Symptoms of SARS-CoV2 infection
What they're measuring
1
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restoration, FDI Score 1-5
Timeframe: Baseline (7-10 days)
2
FDI 11 Postoperative Hypersensitivity After Inlay/Onlay Restorations, FDI Score 1-5