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

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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Recruitment Status : Withdrawn (No patients could be recruited)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

Study Description
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Brief Summary:
Immunologically evaluation of myeloperoxidase level as indicator for inflammatory reactions on modified surface abutments compared to machined surface abutments.

Condition or disease Intervention/treatment Phase
Tooth Loss Device: ESTA abutment Roxolid Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Comparative, Randomized, Prospective, Clinical Pilot Study to Evaluate the Performance of Modified Study Abutments in Single Tooth Gaps
Study Start Date : December 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015
Arms and Interventions
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Arm Intervention/treatment
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.

 Device: ESTA abutment Roxolid
Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219139


Locations
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Switzerland
Universität Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
Institut Straumann AG
Investigators
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Principal Investigator: Anton Sculean, Dr med dent University Bern, Zahnmedizinische Kliniken Bern
More Information
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Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT02219139    
Other Study ID Numbers: CR 03/10 ESTA
CIV-12-10-009101 ( Other Identifier: EUDAMED )
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Straumann AG:
Edentulous
Roxolid
SLAclive surface
Titanium/zirconium
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases