N/A
N=46
Implant Survival After Insertion of Bone Level Tapered (BLT) Implant Ø 2.9 mm in the Clinical Practice Setting
Tooth Loss
Bottom Line
View on ClinicalTrials.gov: NCT02699866 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Implant Survival Rate at 12 Months After Implant Placement — 92.68 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BLT Implant Ø 2.9 mm (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate at 12 Months After Implant Placement |
92.68 | — |
| SECONDARY Pink Esthetic Score (PES) at 6 Months After Implant Placement |
11.2 | — |
Summary
The Straumann Bone Level Tapered (BLT) implant Ø 2.9 mm implant was developed to allow treatment of patients with single tooth gaps of small dimensions in the lateral and central incisor positions in the mandible and in the lateral incisor positions in the maxilla. These positions are reduced-load-bearing compared to more posterior positions.
During this study performance and safety of the Straumann BLT implants Ø 2.9 mm in the clinical practice setting will be investigated.
Eligibility Criteria
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 are collected and analyzed.
- Patients must be males or females who are a minimum of 18 years of age.
- Patients with a minimum of 4 weeks history of edentulism in the study area, minimal interdental space and in need of a single tooth replacement with a dental implant central and lateral incisors in the mandible and lateral incisors in the maxilla (Federation Dentaire Internationale (FDI) positions 12, 22, 31, 32, 41 or 42).
- Presence of natural tooth or implants adjacent to the study implant position (single tooth gap).
- Patients with complete soft tissue coverage of the socket at implant placement.
Exclusion Criteria
- Patients with inadequate bone volume and / or quality or metabolic bone disorder.
- Patients with local root remnants.
- Patients with inadequate wound healing capacity.
- Patients with not completed maxillary and mandibular growth.
- Patients with serious internal medical problems, 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 poor general state of health.
- Patients with drug or alcohol abuse.
- Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy.
- 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.
- A woman who is pregnant or planning to become pregnant at any point during the study duration.
Data sourced from ClinicalTrials.gov (NCT02699866). 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.