Clinical trial NCT02219139: A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps
Official title: A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Loss
Keywords: Edentulous
Roxolid
SLAclive surface
Titanium/zirconium
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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 at the abutment site at several visits before and during abdication of oral hygiene.

The study finishes with biopsy visit. Afterwards a regular abutment will be placed and the patients will be treated according to the standard protocol of the clinic to obtain their final restoration

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.
timeFrame: Inflammation assessment and biopsy at study day 70.
Secondary outcomes:
measure: Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6.
timeFrame: 20-24 weeks
measure: evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments
timeFrame: 20-24 weeks
measure: Evaluation of clinical inflammatory parameters of modified surface abutments compared to machined surface abutments based on modified Mombelli plaque index and modified Lobene gingival index.
timeFrame: 20-24 weeks
measure: Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments
timeFrame: 9 weeks after abutment placement
measure: Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments
timeFrame: At 8 weeks after abutment placement
measure: Evaluation of bacterial community at the abutment site
timeFrame: 28 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universität Bern
Study officials:
affiliation: University Bern, Zahnmedizinische Kliniken Bern
name: Anton Sculean, Dr med dent
role: PRINCIPAL_INVESTIGATOR
References: