Surgical Peri-implantitis Treatment With and Without Implantoplasty
Overview
- Phase
- Not Applicable
- Intervention
- Open flap debridement alone
- Conditions
- Peri-Implantitis
- Sponsor
- University of Oslo
- Enrollment
- 35
- Locations
- 3
- Primary Endpoint
- Bleeding on probing
- Status
- Recruiting
- Last Updated
- 3 days ago
Overview
Brief Summary
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.
Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.
Investigators
Anders Verket
Associate Professor
University of Oslo
Eligibility Criteria
Inclusion Criteria
- •Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
- •Competent to give consent
- •Exposed, modified implant surface with loss \>2mm
Exclusion Criteria
- •Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
- •Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
- •Patients classified as \> class II according to ASA classification
- •Implant unavailable for implantoplasty treatment
- •Inhability to comprehend and respond to the quality of life questionnaire
- •Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
- •History of peri-implantitis surgery prior to 6 months of screening
Arms & Interventions
Peri-implantitis treatment without implantoplasty
Open flap debridement withput implantoplasty treatment
Intervention: Open flap debridement alone
Peri-implantitis treatment with implantoplasty
Open flap debridement with implantoplasty treatment
Intervention: Implantoplasty
Peri-implantitis treatment with implantoplasty
Open flap debridement with implantoplasty treatment
Intervention: Open flap debridement alone
Peri-implantitis treatment without implantoplasty
Open flap debridement withput implantoplasty treatment
Intervention: Implantoplasty
Outcomes
Primary Outcomes
Bleeding on probing
Time Frame: 24 months after treatment
Measured with a periodontal probe
Bleeding on probing
Time Frame: 12 months after treatment
Measured with a periodontal probe
Secondary Outcomes
- Clinical attachment loss measurements(24 months after treatment)
- Radiographic bone loss(24 months after treatment)
- Implant fracture(24 months)
- Suppuration(24 months after treatment)
- Pocket probing depth(24 months after treatment)
- Changes in patient-reported quality of life (QoL)(Preoperatively compared to 24 months after treatment)
- Suppuration(12 months after treatment)
- Pocket probing depth(12 months after treatment)
- Clinical attachment loss measurements(12 months after treatment)
- Radiographic bone loss(12 months after treatment)