N/A
N=44
Performance Evaluation of FullCeram Implants in Single Tooth Gaps
Tooth Loss
Bottom Line
View on ClinicalTrials.gov: NCT02163395 ↗Enrolled (actual)
44
Serious AEs
11.4%
Results posted
Jul 2015
Primary outcome: Primary: The Implant Survival — 97.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FullCeram implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Implant Survival |
97.7; 97.6; 97.5 | — |
| SECONDARY The Implant Success |
93.0; 97.6; 95.1; 97.5 | — |
| SECONDARY Mean Bone Level Changes (Distal and Mesial) |
-0.88; -1.02; -1.24; -0.97 | — |
| SECONDARY The Implant Survival |
97.7; 97.6; 97.5 | — |
Summary
* Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone
* The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year
Eligibility Criteria
Inclusion Criteria
- Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
- Males and females with at least 18 years of age (including 18 years)
- Implant placement planned in the maxilla or mandible
- The missing tooth site must have a tooth with a natural root
- Substantially healed and augmented extraction sockets (minimal 8 weeks)
- Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position
Exclusion Criteria
Pre-surgical exclusion criteria:
- Systemic disease that would interfere with dental implant therapy
- Any contraindications for oral surgical procedures
- Mucosal diseases
- History of local irradiation therapy
- Current untreated periodontitis or gingivitis
- Any untreated endodontic lesions
- Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site
- Severe bruxing or clenching habits
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
- Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
- 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
- Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- Pregnant women at screening
Secondary exclusion criteria at or after implant surgery:
- Lack of primary stability of the implant (hand testing directly after surgery)
- Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration)
- Major simultaneous augmentation procedures (at surgery)
- X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)
Data sourced from ClinicalTrials.gov (NCT02163395). 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.