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Clinical Trials/DRKS00026673
DRKS00026673CompletedPhase 1

Surgical peri-implantitis therapy by combination of a plasma and a water jet device - Pilot_PeriPLas

Sirona Dental Systems GmbH0 sites61 target enrollmentStarted: September 17, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
61
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized controlled study
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to one (—)
Sex
All

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

  • •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 < 6 months prior to baseline.
  • •12.Cardiac pacemaker or implanted cardioconverter defibrillator.
  • •13.Asthma.
  • •14.Chronic obstructive pulmonary disease (COPD).
  • •15.Any previous radiation of head or neck region.
  • •16.Bisphosphonate or other anti-bone resorption treatment because of cancer treatment.
  • •17.Self-reported pregnancy in women
  • •18.Lactation (self-reported).
  • •19.Uncontrolled diabetes, based a GP`s laboratory report, not older than 8 weeks (HbA1c > 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

Investigators

Sponsor
Sirona Dental Systems GmbH

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