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

NCT03018795 | Completed

• 1 other identifier: 25901600-2858
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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

Conditions

Peri-Implantitis

Keywords

peri-implantitis; Surgical regenerative treatment; ozone therapy

Outcome Measures

Primary Outcomes (1)

• probing depth of peri-implantitis sites

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

  6 months postoperatively

Secondary Outcomes (1)

• bone loss of peri-implant defects

  6 months postoperatively

Study Arms (2)

Ozone Group

ACTIVE COMPARATOR

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

Procedure: Decontamination of implant surfaces

Control Group

ACTIVE COMPARATOR

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

Procedure: Decontamination of implant surfaces

Interventions

Decontamination of implant surfaces PROCEDURE

Decontamination of implant surfaces in combination with regenerative surgery

Control Group; Ozone Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Related Publications (1)

• 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.

  PMID: 29984044 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berrin Unsal, PhD

  Prof Dr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 12, 2017
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share