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Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decontamination of implant surfaces
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring peri-implantitis, Surgical regenerative treatment, ozone therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age > 18 years,
  2. presence of peri-implantitis exhibiting one of the defect configurations as defined by either a Class Ib (buccal dehiscence + semicircumferential bone resorption), Class Ic (i.e. buccal dehiscence + circular bone resorption) or Class Ie (i.e. circumferential bone resorption) with a probing depth of >6 mm
  3. radiographic bone loss ≥2 mm on at least at one implant surface,
  4. peri-implant sites with bleeding or suppuration after probing,
  5. no implant mobility,
  6. no evidence of occlusal overload
  7. non-smoker.

Exclusion Criteria:

  1. serious systemic disease that would contraindicate for periodontal surgery (i.e. diabetes (HbA1c < 7),
  2. prophylactic antibiotics required or systemic antibiotic administration during the past 3 months, and (3) placement, and prosthetic loading of implants within the past 1 year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ozone Group

    Control Group

    Arm Description

    Decontamination of implant surfaces with saline irrigation and additional ozone therapy in combination with regenerative surgery

    Decontamination of implant surfaces with saline irrigation alone in combination with regenerative surgery

    Outcomes

    Primary Outcome Measures

    probing depth of peri-implantitis sites
    measured as the distance between the deepest site of the pocket to the peri-implant mucosal margin

    Secondary Outcome Measures

    bone loss of peri-implant defects
    Measurements were taken of mesial and distal distances between the first bone to implant contact and bone loss (BL) in the implant shoulder

    Full Information

    First Posted
    January 10, 2017
    Last Updated
    January 10, 2017
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03018795
    Brief Title
    Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis
    Official Title
    The Effect of Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Decontamination procedure is a challenging factor that affects the success of surgical regenerative therapy (SRT) of peri-implantitis. The purpose of the present study was to determine the impact of additional ozone therapy for the decontamination of implant surfaces in SRT of peri-implantitis. A total of 21 patients with moderate or advanced peri-implantitis were randomly allocated to the test group (ozone group) with the use of sterile saline with additional ozone therapy or the control group with sterile saline alone for decontamination of the implant surfaces in SRT of peri-implantitis. Clinical and radiographic outcomes were evaluated at baseline and 6 months postoperatively
    Detailed Description
    Peri-implant diseases are described as inflammatory processes in the tissues surrounding implants in response to mainly microbial biofilms on the surface of the implants (Zitzmann and Berglundh 2008). Peri-implant mucositis is described as an inflammatory reaction triggered by microbial biofilms without any loss of peri-implant bone, while peri-implantitis is characterized by bleeding when probed and/or suppuration with further loss of the peri-implant bone (Lindhe and Meyle 2008; Lang and Berglundh 2011). Since microbial biofilms play a major role in the etiology (Becker et al. 1990; Quirynen et al. 2002), it has been considered that elimination of microbial pathogens is mandatory in the treatment of peri-implant diseases (Mombelli and Lang 1994; Schwarz et al. 2006). The objectives of peri-implantitis therapy are implant surface decontamination to resolve inflammation resolution while preserving the implant supporting tissues (Lindhe and Meyle 2008; Heitz-Mayfield and Lang 2010). Several implant decontamination methods have been suggested, including mechanical debridement, chemical therapy (applications of root conditioners, disinfectants, and local and systemic antibiotic therapy) (Heitz-Mayfield et al. 2012; Wohlfahrt et al. 2012) and surgical procedures aiming to remove bacteria, and smooth, decontaminate and detoxify the implant surface (Froum et al. 2012; Schwarz et al. 2013). However, there is as yet no consensus on the most effective protocol for implant surface detoxification (Suarez et al. 2013). Ozone has a strong oxidation effect with remarkable antimicrobial potential and can be used as a disinfectant in clinical applications of dentistry (Iliadis and Millar 2013). A previous study reported that ozone has powerful antimicrobial activity in response to anaerobic periodontal pathogenic microorganisms and may have the potential to be used as an adjunctive tool in non-surgical periodontal therapy in periodontitis patients (Eick et al. 2012). Ozone therapy can promote haemostasis, enhance the release of growth factors and local oxygen supply, upregulate cellular antioxidant enzymes and inhibit bacterial proliferation (Ozdemir et al. 2013). However, current literature has little information regarding the antimicrobial activity of ozone in the treatment of peri-implant diseases. A previous randomized, clinical study showed that ozone therapy reduced inflammation in the treatment of peri-implant mucositis (McKenna et al. 2013). Another in-vitro trial reported that in the reduction of adherent bacteria on titanium, gaseous ozone showed selective efficacy without any adverse effect on the surface structures of the titanium surfaces or the adhesion and proliferation of osteoblastic cells (Huser-Gerspach et al. 2012). Non-surgical therapy alone has been reported to be inadequate for the treatment of moderate and severe forms of peri-implantitis and therefore surgical therapy is frequently required (Lindhe and Meyle 2008). The goals of surgical therapy of peri-implantitis are mainly to be able to access areas for mechanical debridement and implant surface decontamination and to reconstruct the anatomic conditions to improve plaque control and to eliminate the pathological peri-implant pockets (Esposito et al. 2012; Roos-Jansaker et al. 2014). This can be achieved with resection or with procedures of bone regeneration such as guided bone regeneration (Roos-Jansaker et al. 2003; Schou et al 2004; Sahrmann et al. 2011). Studies have evaluated the combination of various regenerative biological agents and techniques for surgical regenerative therapy (SRT) of peri-implantitis and clinical and radiological improvements following different bone augmentation procedures have been reported (Claffey et al. 2008; Schwarz et al. 2009; Roos-Jansaker et al. 2011; Renvert et al. 2012). A long-term, clinical study demonstrated that vertical peri-implant bone defects (PBDs) may be actively treated by regenerative surgical means, using a bone substitute alone or in combination with a membrane (Roos-Jansaker et al. 2014). Platelet concentrates are preferred in periodontal surgical procedures for the purpose of accelerating angiogenesis, stimulating the activity of osteoblasts and fibroblasts, and obtaining regeneration of hard and soft tissues, including stem cells and growth factors (Del Fabbro et al. 2011). These materials can be used alone or in combination with bone grafts or barrier membranes. In studies employing bone grafts with the use of platelet rich fibrin (PRF) or PRF alone around PBDs it has been reported that PRF leads to increased new bone formation and a higher bone to implant contact ratio (Lee et al. 2012; Simsek et al. 2016). A recent study reported that treatment of peri-implantitis using PRF was clinically more effective than with access flap surgery alone. It was also concluded in the study that PRF improves the outcomes of surgical peri-implantitis treatment (Hamzacebi et al. 2015). There have been recent developments of various techniques using platelet concentrate to provide different rates of platelets, leukocytes, growth factors, stem cells and fibrin matrix. Sacco developed concentrated growth factors (CGF) as a therapeutic protocol obtained by separating the venous blood centrifuged using a special device in the same manner as PRF (Rodella et al. 2011). It was also argued that centrifugation at a different speed provides a larger, denser fibrin matrix compared to PRF, which results in improved regenerative capacity and greater versatility (Sohn et al. 2009). Some recent studies have reported that CGF accelerates new bone formation related to guided bone regeneration (Sohn et al. 2011; Kim et al. 2014). The purpose of this randomized, controlled clinical study was to evaluate the clinical and radiological results of implant surface decontamination using sterile saline alone or in combination with ozone therapy applied as surgical regenerative treatment for peri-implantitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peri-Implantitis
    Keywords
    peri-implantitis, Surgical regenerative treatment, ozone therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ozone Group
    Arm Type
    Active Comparator
    Arm Description
    Decontamination of implant surfaces with saline irrigation and additional ozone therapy in combination with regenerative surgery
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Decontamination of implant surfaces with saline irrigation alone in combination with regenerative surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Decontamination of implant surfaces
    Intervention Description
    Decontamination of implant surfaces in combination with regenerative surgery
    Primary Outcome Measure Information:
    Title
    probing depth of peri-implantitis sites
    Description
    measured as the distance between the deepest site of the pocket to the peri-implant mucosal margin
    Time Frame
    6 months postoperatively
    Secondary Outcome Measure Information:
    Title
    bone loss of peri-implant defects
    Description
    Measurements were taken of mesial and distal distances between the first bone to implant contact and bone loss (BL) in the implant shoulder
    Time Frame
    6 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age > 18 years, presence of peri-implantitis exhibiting one of the defect configurations as defined by either a Class Ib (buccal dehiscence + semicircumferential bone resorption), Class Ic (i.e. buccal dehiscence + circular bone resorption) or Class Ie (i.e. circumferential bone resorption) with a probing depth of >6 mm radiographic bone loss ≥2 mm on at least at one implant surface, peri-implant sites with bleeding or suppuration after probing, no implant mobility, no evidence of occlusal overload non-smoker. Exclusion Criteria: serious systemic disease that would contraindicate for periodontal surgery (i.e. diabetes (HbA1c < 7), prophylactic antibiotics required or systemic antibiotic administration during the past 3 months, and (3) placement, and prosthetic loading of implants within the past 1 year.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Berrin Unsal, PhD
    Organizational Affiliation
    Prof Dr
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29984044
    Citation
    Isler SC, Unsal B, Soysal F, Ozcan G, Peker E, Karaca IR. The effects of ozone therapy as an adjunct to the surgical treatment of peri-implantitis. J Periodontal Implant Sci. 2018 Jun 30;48(3):136-151. doi: 10.5051/jpis.2018.48.3.136. eCollection 2018 Jun.
    Results Reference
    derived

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    Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis

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