Evaluation of a new dental adhesive for indirect restorations
Clinical Evaluation of a New Dual-cure Universal Adhesive for Indirect Restorative Treatment
This study is testing a new dental glue for attaching ceramic restorations to see if it causes less sensitivity and works well over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ivoclar Vivadent AG Industry-sponsored |
| Locations | 1 site (Schaan) |
| Trial ID | NCT06615544 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical performance and safety of a new dual-cure adhesive used for luting indirect ceramic restorations, such as inlays and onlays. The primary focus is on measuring the occurrence of postoperative hypersensitivity following the use of this adhesive. Additionally, the study will evaluate the long-term performance of the adhesive in terms of the quality of margins, retention and fracture rates of the restorations, and the vitality and fracture rates of the restored teeth.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who require indirect restorations in molars or premolars and have healthy teeth and gums.
Not a fit: Patients with severe systemic diseases, high caries activity, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental restoration techniques with reduced postoperative sensitivity and enhanced longevity of restorations.
How similar studies have performed: While the specific approach of this adhesive may be novel, similar studies evaluating dental adhesives have shown promising results in improving restoration outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-65 years * Informed consent signed and understood by the subject * Indication for indirect restorations (inlay, onlay) in molar or premolar * The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth. * visual analogue scale (VAS)\<4 (0=no pain, 10=maximum conceivable pain) * 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: * Insufficient isolation * 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 * Tooth with irreversible pulpitis * Indication for direct pulp capping * Bleaching of teeth within the last 14 days * Usage of peroxide-based disinfectants within the last 14 days
Where this trial is running
Schaan
- Ivoclar Vivadent AG — Schaan, Liechtenstein (Recruiting)
Study contacts
- Study coordinator: Patrizia Elkuch-Hoch
- Email: Patrizia.Elkuch-Hoch@ivoclar.com
- Phone: +423 235 3780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.