Dental Implants, Single-Tooth Clinical Trial
Official title:
Comparative Performance of Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow: A Multicentre Multinational Randomized Controlled Clinical Trial
Verified date | March 2024 |
Source | Institut Straumann AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
Status | Active, not recruiting |
Enrollment | 124 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analysed, and published. - Patients must be males or females who are a minimum of 18 years of age. - Patients, who are in need of a single tooth replacement with a dental implant in the premolar-to-premolar area in the mandible or maxilla (excluding lower incisors). - Presence of natural teeth on both sides of the study implant position and opposing dentition (single tooth gap). - Patients with healed extraction sockets, which means that at implant surgery: - Soft tissue coverage of the socket is complete; and - Alveolar bone is reconsolidated (around 16 weeks after tooth extraction). Exclusion Criteria: - Patients with inadequate bone volume where major bone augmentation would be required at implant location. - Inadequate anatomic situation that would prevent prosthetic-driven planning based on CBCT. - Presence of implants neighbouring the study implant. - Patients with inadequate oral hygiene (FMPS = 20%). - Patients with local root remnants. - Patients with inadequate wound healing capacity. - Patients with incomplete maxillary and mandibular growth. - Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders. - Patients with drug or alcohol abuse. - Patients with allergies or hypersensitivity to zirconium oxide (ZrO2), yttrium oxide (Y2O3), hafnium dioxide (HfO2), aluminium oxide (Al2O3), and titanium (Grade 4). - Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders). - Patients with conditions or circumstances, in the opinion of the Investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability. - Pregnancy or intention to become pregnant at any point during the study duration. Furthermore, patients with uncontrolled periodontitis and less than 3 mm of keratinized mucosa at the day of surgery will be excluded from the study. Controlled periodontitis is defined as treated periodontitis with two or less pockets that are < 4 mm in depth or the existence of = 20% bleeding on probing. If the planned implant position is the second premolar, the adjacent molar must be present. Shortened arches with missing molars are not eligible in such a case. |
Country | Name | City | State |
---|---|---|---|
Germany | Dusseldorf University Hospital, Poliklinik für Zahnärztliche Prothetik | Düsseldorf | |
Hong Kong | The University of Hong Kong, Prince Philip Dental Hospital | Hong Kong | |
Portugal | Implantology Institute | Lisboa |
Lead Sponsor | Collaborator |
---|---|
Institut Straumann AG | Avania |
Germany, Hong Kong, Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | Adverse Events will be recorded at every visit. | 18 months after inclusion. | |
Other | Device Deficiencies | Any device complications and deficiencies will be recorded as Device Deficiencies. | 18 months after inclusion. | |
Primary | Bone Level Change | Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading [mm]. | 12 months after implant loading (final crown restoration) | |
Secondary | Implant survival | Implant survival rates 3, 6 months and 1 year after loading: yes/no | 12 months after loading. | |
Secondary | 14 item Oral Health Impact Profile (OHIP-14) | The local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4). | 12 months after loading. |
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