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Peri-ImplantitisNCT03018795

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

A study testing Decontamination of implant surfaces in people with Peri-Implantitis, run by Gazi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Peri-Implantitis
What is being tested?
Decontamination of implant surfaces
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
Sep 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: The Effect of Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial

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

Read the 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.

Being tested
Decontamination of implant surfaces
Keywords
peri-implantitis, Surgical regenerative treatment, ozone therapy
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decontamination of implant surfacesProcedure or surgery

    Decontamination of implant surfaces in combination with regenerative surgery

Study groups in NCT03018795
Study groupRoleWhat they receive
Ozone GroupActive comparatorDecontamination of implant surfaces with saline irrigation and additional ozone therapy in combination with regenerative surgery
Receives: Procedure: Decontamination of implant surfaces
Control GroupActive comparatorDecontamination of implant surfaces with saline irrigation alone in combination with regenerative surgery
Receives: Procedure: Decontamination of implant surfaces

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. probing depth of peri-implantitis sites

    measured as the distance between the deepest site of the pocket to the peri-implant mucosal margin

    Measured: 6 months postoperatively

Secondary outcomes (1)
  1. 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

    Measured: 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study startSep 2014
  3. Primary completionJan 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03018795
Sponsor's protocol ID
25901600-2858
Status last verified
Jan 2017
First submitted
10 Jan 2017
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29984044

Questions about this trial

What is this clinical trial studying?

A study testing Decontamination of implant surfaces in people with Peri-Implantitis, run by Gazi University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

probing depth of peri-implantitis sites (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03018795, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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