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The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy

Primary Purpose

Periimplantitis, Peri-implant Mucositis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chitosan brush
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periimplantitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Overt peri-implantitis presenting at least one implant with;

  • radiographic bone loss ≥ 2.0 mm
  • bleeding on probing (BoP)

Main exclusion criteria:

  • radiotherapy
  • chemotherapy
  • systemic long-term corticosteroid treatment
  • pregnancy or nursing
  • anatomical abnormalities
  • history of previous treatment of peri-implantitis within 6 months after the screening
  • American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery > 2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test

    Control

    Arm Description

    Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes

    Treatment/maintenance of implants postsurgically performed by the use of titanium curettes

    Outcomes

    Primary Outcome Measures

    Inflammation control
    Absence/presence of bleeding on probing and deep peri-implant pockets

    Secondary Outcome Measures

    Progressive bone loss
    Loss of attachment at the implant identified on radiographs

    Full Information

    First Posted
    January 29, 2018
    Last Updated
    April 28, 2021
    Sponsor
    University of Oslo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03421717
    Brief Title
    The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
    Official Title
    The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2012 (Actual)
    Primary Completion Date
    December 9, 2016 (Actual)
    Study Completion Date
    April 28, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oslo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.
    Detailed Description
    Little is known about the effect of chair-side maintenance of dental implants after peri-implantitits surgery. Traditionally, the maintenance has been performed by titanium curettes to remove microbiological deposits from the submucosal area. The Labrida biodegradable brush is a novel debridement device intended for use on dental implants. The concept of using a biodegradable material is related to the suggested problems with leaving remnants on the treated implant surface which would be negative from a bone regenerative aspect. The use of a flexible brush relates to the access problems when treating dental implants both related to the threads as well as due to the prosthetic supra construction hindering access for debridement with regular instruments developed for teeth. The material used in the brush will be Chitosan which is a natural polysaccharide, chitosan (poly-N-acetyl glucosaminoglycan), which is a nontoxic and bioabsorbable (REK-approval 2012/791 polymer). H0: It is possible to maintain peri-implant health after surgical peri-implantitis treatment. There is no short- or long term clinical or radiographical differences between patients surgically treated for peri-implantitis maintained by the use of titanium cyrettes or with the Labrida brush in chair-side supportive care

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periimplantitis, Peri-implant Mucositis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    6 month after surgical intervention, the population is randomly assigned to two parallel groups, receiving one of two maintenance programs - use of titanium curettes or chitosan brushes. Randomization was performed by pulling notes test/control.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Maintenance treatment (test/control) was performed after the investigator left the room. Investigator did not have access to the registration forms where information regarding assignment (test/control) was noted
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test
    Arm Type
    Experimental
    Arm Description
    Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Treatment/maintenance of implants postsurgically performed by the use of titanium curettes
    Intervention Type
    Device
    Intervention Name(s)
    Chitosan brush
    Other Intervention Name(s)
    Titanium curettes
    Intervention Description
    If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
    Primary Outcome Measure Information:
    Title
    Inflammation control
    Description
    Absence/presence of bleeding on probing and deep peri-implant pockets
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Progressive bone loss
    Description
    Loss of attachment at the implant identified on radiographs
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Overt peri-implantitis presenting at least one implant with; radiographic bone loss ≥ 2.0 mm bleeding on probing (BoP) Main exclusion criteria: radiotherapy chemotherapy systemic long-term corticosteroid treatment pregnancy or nursing anatomical abnormalities history of previous treatment of peri-implantitis within 6 months after the screening American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery > 2
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Odd Carsten Koldsland, Ph.D
    Organizational Affiliation
    Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be handeled by the investigators treating the patients and collecting data

    Learn more about this trial

    The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy

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