ClinicalTrials.gg
RecruitingNCT04052373Updated Apr 29, 2026

Peri-implantitis Implantoplasty Treatment

An interventional study of Implantoplasty and Open flap debridement alone in Peri-Implantitis and Peri-implant Mucositis, sponsored by University of Oslo. Recruiting at 2 sites in Norway. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University of Oslo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-Implantitis
  • Peri-implant Mucositis

Browse trials for

03

In context

Peri-Implantitis

322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.

This study's planned enrollment of 35 is below the median of 40 across 195 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term treatment
  • Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
  • Patients classified as > class II according to
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Peri-implantitis treatment with implantoplasty

    Open flap debridement with implantoplasty treatment

    Procedure: Implantoplasty · Procedure: Open flap debridement alone

  • Active comparator
    Peri-implantitis treatment without implantoplasty

    Open flap debridement withput implantoplasty treatment

    Procedure: Implantoplasty · Procedure: Open flap debridement alone

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

06

What researchers measure

Primary outcomes

  1. Bleeding on probing

    Measured with a periodontal probe

    Time frame: 12 months after treatment

  2. Bleeding on probing

    Measured with a periodontal probe

    Time frame: 24 months after treatment

Secondary outcomes

  1. Suppuration

    Visible suppuration upon probing the implant with a periodontal probe

    Time frame: 12 months after treatment

  2. Suppuration

    Visible suppuration upon probing the implant with a periodontal probe

    Time frame: 24 months after treatment

  3. Pocket probing depth

    Measured with a periodontal probe

    Time frame: 12 months after treatment

  4. Pocket probing depth

    Measured with a periodontal probe

    Time frame: 24 months after treatment

  5. 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)

    Time frame: Preoperatively compared to 24 months after treatment

  6. Clinical attachment loss measurements

    Measured with a periodontal probe

    Time frame: 12 months after treatment

  7. Clinical attachment loss measurements

    Measured with a periodontal probe

    Time frame: 24 months after treatment

  8. Radiographic bone loss

    Measured on standardized radiograps

    Time frame: 12 months after treatment

  9. Radiographic bone loss

    Measured on standardized radiograps

    Time frame: 24 months after treatment

  10. Implant fracture

    Clinical examination to assess whether implants have fractured following treatment

    Time frame: 24 months

07

Study locations

2 of 2 sites recruiting
  • Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
    Oslo, Oslo 0455, Norway
    Recruiting
  • Institute of Clinical Dentistry, University of Oslo, Norway
    Oslo, Norway
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Jun 2027, 92 months after the start.

Of 119 non-industry interventional studies with no phase under Peri-Implantitis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 92 months is above that.

Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 12 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2019
First posted
Aug 9, 2019
StartActual
Oct 15, 2019
Primary completionEst.
Jun 15, 2027
CompletionEst.
Jun 15, 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04052373
Lead sponsor
University of Oslo
Responsible party
Anders Verket (Associate Professor, University of Oslo) — Principal investigator
First posted
Aug 9, 2019
Start date
Oct 15, 2019
Primary completion
Jun 15, 2027 (estimated)
Completion
Jun 15, 2027 (estimated)
Last update
Apr 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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