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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 anaerobi
Sponsor: Gazi University

Current Primary Outcome: probing depth of peri-implantitis sites [ Time Frame: 6 months postoperatively ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: bone loss of peri-implant defects [ Time Frame: 6 months postoperatively ]

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


Original Secondary Outcome: Same as current

Information By: Gazi University

Dates:
Date Received: January 10, 2017
Date Started: September 2014
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017