Status:
WITHDRAWN
A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps
Lead Sponsor:
Institut Straumann AG
Conditions:
Tooth Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
Detailed Description
One study abutment per patient will be placed. After healing for 6 to 7 weeks, patients will be asked to stop oral hygiene at the study site for 2 weeks. Sulcus fluid and plaque samples will be taken...
Eligibility Criteria
Inclusion
- Subjects must have voluntary signed the informed consent form before any study related action.
- Males and females with at least 18 years of age
- Non-smokers
- Straumann bone level implant (healed for at least 4 weeks) in a tooth gap in the maxilla or mandible with thick tissue biotype
- Adequate oral hygiene (Full mouth plaque index; O'Leary, et al. 1972) \<25% at abutment placement
- The patient must be able to open the mouth to allow removal of the abutment at the planned abutment site
Exclusion
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any antibiotic treatment or anti-inflammatory treatment within the past 2 month
- Any contraindications for oral surgical procedures
- Mucosal diseases (e.g. lichen planus, mouth ulcer)
- History of local irradiation therapy
- Current treated (within the last 12 month) or untreated periodontitis
- Current treated (within the last 6 month) or untreated gingivitis
- Probing pocket depth of ≥4 mm on one of the teeth immediately adjacent to the dental implant site
- Severe bruxing or clenching habits
- Lack of primary stability of the implant at abutment placement
- 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 follow protocol procedures
- Pregnant or breastfeeding wome
- Insufficient soft tissue attachment to the neck of the abutment (e.g. visibility of the abutment platform or exposed ESTAnsurface) after abutment placement
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02219139
Start Date
December 1 2012
End Date
June 1 2015
Last Update
March 3 2016
Active Locations (1)
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1
Universität Bern
Bern, Canton of Bern, Switzerland, 3010