Peri-Implantitis Clinical Trial
Official title:
The Effect of Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial
Verified date | January 2017 |
Source | Gazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 21 |
Est. completion date | September 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gazi University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | 6 months postoperatively | No |
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