Peri-ImplantitisNCT04052373
Peri-implantitis Implantoplasty Treatment
A study testing Implantoplasty and Open flap debridement alone in people with Peri-Implantitis and Peri-implant Mucositis, run by University of Oslo at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis
- What is being tested?
- Implantoplasty and Open flap debridement alone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesNorway
- Study dates
- 15 Oct 2019to 15 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, Oslo, 0455
Anders Verket, PhD, +47 93667661, anderver@odont.uio.no
Odd Koldsland, PhD, +47 93098618, oddcko@odont.uio.no
- Recruiting
Institute of Clinical Dentistry, University of Oslo, Norway
Oslo
Anders Verket, PhD, +47 22852064, anderver@odont.uio.no
About this study
Official title: Surgical Peri-implantitis Treatment With and Without Implantoplasty
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.
- Conditions
- Peri-Implantitis, Peri-implant Mucositis
- Being tested
- Implantoplasty, Open flap debridement alone
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantoplastyProcedure or surgery
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.
Open flap debridement aloneProcedure or surgery
Open flap debridement alone
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis treatment with implantoplasty | Experimental | Open flap debridement with implantoplasty treatment Receives: Procedure: Implantoplasty; Procedure: Open flap debridement alone |
| Peri-implantitis treatment without implantoplasty | Active comparator | Open flap debridement withput implantoplasty treatment Receives: Procedure: Implantoplasty; Procedure: Open flap debridement alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Measured with a periodontal probe
Measured: 12 months after treatment
Bleeding on probing
Measured with a periodontal probe
Measured: 24 months after treatment
Secondary outcomes (10)
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Measured: 12 months after treatment
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Measured: 24 months after treatment
Pocket probing depth
Measured with a periodontal probe
Measured: 12 months after treatment
Pocket probing depth
Measured with a periodontal probe
Measured: 24 months after treatment
Changes in patient-reported quality of life (QoL)
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)
Measured: Preoperatively compared to 24 months after treatment
Clinical attachment loss measurements
Measured with a periodontal probe
Measured: 12 months after treatment
Clinical attachment loss measurements
Measured with a periodontal probe
Measured: 24 months after treatment
Radiographic bone loss
Measured on standardized radiograps
Measured: 12 months after treatment
Radiographic bone loss
Measured on standardized radiograps
Measured: 24 months after treatment
Implant fracture
Clinical examination to assess whether implants have fractured following treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Oct 2019
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Verket, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052373
- Sponsor's protocol ID
- IMPLANTOPLASTY
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No