Recruiting NCT04052373
Peri-implantitis Implantoplasty Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantoplasty, Open flap debridement alone.
- Who it may be relevant to
- Registry conditions: Peri-Implantitis, Peri-implant Mucositis. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surgical Peri-implantitis Treatment With and Without Implantoplasty
Overview
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.
Interventions
- Procedure Implantoplasty
Implantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene. - Procedure Open flap debridement alone
Open flap debridement alone
Primary outcome measures
- Bleeding on probing [Time frame: 12 months after treatment]
- Bleeding on probing [Time frame: 24 months after treatment]
Secondary outcome measures (10)
- Suppuration [Time frame: 12 months after treatment]
- Suppuration [Time frame: 24 months after treatment]
- Pocket probing depth [Time frame: 12 months after treatment]
- Pocket probing depth [Time frame: 24 months after treatment]
- Changes in patient-reported quality of life (QoL) [Time frame: Preoperatively compared to 24 months after treatment]
- Clinical attachment loss measurements [Time frame: 12 months after treatment]
- Clinical attachment loss measurements [Time frame: 24 months after treatment]
- Radiographic bone loss [Time frame: 12 months after treatment]
- Radiographic bone loss [Time frame: 24 months after treatment]
- Implant fracture [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Norway · 2 centers
- Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo — Oslo
- Institute of Clinical Dentistry, University of Oslo, Norway — Oslo
Identifiers
NCT: NCT04052373 · IMPLANTOPLASTY