Peri-Implantitis, Peri-implant Mucositis
Conditions
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.
Interventions
PROCEDUREImplantoplasty
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.
PROCEDUREOpen flap debridement alone
Open flap debridement alone
Sponsors
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on probing | 12 months after treatment | Measured with a periodontal probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pocket probing depth | 12 months after treatment | Measured with a periodontal probe |
| Changes in patient-reported quality of life (QoL) | Preoperatively compared to 24 months after treatment | To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of The Oral Impacts on Daily Performance (OIDP) instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1) |
| Suppuration | 12 months after treatment | Visible suppuration upon probing the implant with a periodontal probe |
| Radiographic bone loss | 12 months after treatment | Measured on standardized radiograps |
| Implant fracture | 24 months | Clinical examination to assess whether implants have fractured following treatment |
| Clinical attachment loss measurements | 12 months after treatment | Measured with a periodontal probe |
Countries
Norway
Outcome results
None listed