Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219139
Recruitment Status : Withdrawn (No patients could be recruited)
First Posted : August 18, 2014
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Tracking Information
First Submitted Date  ICMJE July 17, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
Evaluation of Myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments. [ Time Frame: Inflammation assessment and biopsy at study day 70. ]
A biopsy will be taken at study day 70. The study abutment will be removed together with a small slice of the surrounding soft tissue to histologically evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
  • Evaluation of myeloperoxidase level of modified surface abutments compared to machined surface abutment at visit 2, 3, 4, and 6. [ Time Frame: 20-24 weeks ]
    A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
  • evaluation of inflammatory parameters of modified surface abutment compared to machined surface abutments [ Time Frame: 20-24 weeks ]
    A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
  • 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. [ Time Frame: 20-24 weeks ]
    A immunology sample will be taken 2-3 weeks after abutment placement, followed on week 6-7, week 8, week 9, and at week 20-24.
  • Evaluation of subgingival plaque extension of modified surface abutments compared to machined surface abutments [ Time Frame: 9 weeks after abutment placement ]
    Patients will be asked to suspend oral hygiene in the area of the abutment. after 42-49 days after abutment placement for 14 days. At study week 8 a histological sample will be taken
  • Evaluation of soft tissue around the abutment of modified surface abutment compared to machined surface abutments [ Time Frame: At 8 weeks after abutment placement ]
    8 weeks after abutment placement patients have been asked for 14 days of abdication of oral hygiene. A histological sample will be taken then.
  • Evaluation of bacterial community at the abutment site [ Time Frame: 28 days ]
    At study day 42-49, day 49-56, day 56-63, and day 77-105 a microbiological sample will be taken
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative, Randomized, Prospective, Performance Evaluation of Abutments in Single Tooth Gaps
Official Title  ICMJE A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Tooth Loss
Intervention  ICMJE Device: ESTA abutment Roxolid
Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.
Study Arms  ICMJE ESTA abutment Roxolid

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.

Intervention: Device: ESTA abutment Roxolid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 5, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2014)
40
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219139
Other Study ID Numbers  ICMJE CR 03/10 ESTA
CIV-12-10-009101 ( Other Identifier: EUDAMED )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Straumann AG
Study Sponsor  ICMJE Institut Straumann AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anton Sculean, Dr med dent University Bern, Zahnmedizinische Kliniken Bern
PRS Account Institut Straumann AG
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP