peri-implantitis K10.9
Conditions
Interventions
Group 1: Cleaning of the implant by means of waterjet and cold plasma device during flap surgery (test group)
Group 2: Cleaning of the implant with a gauze pellet soaked in saline solution during a fl
Sponsors
Sirona Dental Systems GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age of the patient =18 years. 2. Patient signed and dated the informed consent form. 3. Titanium implant 4. Implants must be in place for = 2 years. 5. At least one site with presence of pocket probing depth (PPD) = 6 mm at selected implant. 6. At least one site with BoP (scores 2, 3 and 4, see section 5.5.2.1) at the selected implant. 7. Bone levels = 3 mm at selected implant apical of the implant-abutment junction or implant shoulder or in case of tissue level implants of the smooth-rough transition. 8. Sufficient knowledge of German language.
Exclusion criteria
Exclusion criteria: 1. Unlikely to be able to comply with study procedures, according to Investigator’s judgment. 2. Involvement in the planning and conduct of the study or being a dental student or dental professional in a hierarchy dependent position of the participating study center 3. Mobility of selected implant. 4. Implants with bone loss exceeding 2/3 of the length of the implant. 5. Previous surgical peri-implantitis treatment at selected implant (self-reported). 6. Less than 3 sites can be probed around selected implant. 7. Active smokers: only non-smokers and ex-smokers are recruited into the study 8. Systemic antibiotic treatment (currently or at less than 3 months prior to baseline). 9. Requiring anticoagulant treatment (ASS > 100 mg/day, phenprocoumon, any new oral anticoagulants) 10. Long-term (> 8 weeks) systemic medication with immunosuppressors, or high doses of corticosteroids (= 10 mg prednisolon-equivalent/day) or biologicals (Etanercept, Abatacept and all immunosuppressing (monoclonal) antibodies). 11. Myocardial infarction, stroke 10%) 20. Incapability of performing basal oral hygiene measures. At Baseline (visit 5): 21. Non-adequate plaque control with a full-mouth plaque score = 40%. 22. More than 20% of bleeding sites. 23. More than 10% residual periodontal pockets = 5 mm. At Surgery (visit 6): 24. Inaccessible infrabony defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to provide an effect estimate (with 95% confidence intervals) for the change of mean probing pocket depth (PPD) at treated implants as an indicator of resolution of the inflammatory lesion. Evidence of preliminary effectiveness will be assumed, if the mean PPD difference between test and control group is > 0 and confidence intervals with a certain width include the Minimal Clinically Important Difference (MCID) (Bell et al., 2018; E. C. Lee et al., 2014). The MCID is set at 0.5 mm for mean PPD, expecting larger reductions in the test group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to provide effect estimates for the secondary endpoints: 1. resolution of inflammation with the secondary outcome variable "change in bleeding on probing (BoP) of implants" 2. implants responding to treatment with the secondary outcome variable "implants with PPD 5 mm and bleeding (values 2, 3, and 4)" 4. preservation of the marginal mucosa with the secondary outcome variable "recession, change in gingival volume". | — |
Countries
Germany
Contacts
Public ContactChristian Eberhard
Sirona Dental Systems GmbH
Outcome results
None listed