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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Peri-implantitis Treatment With and Without Implantoplasty
- ClinicalTrials.gov ID
- NCT04052373
- Acronym / sponsor ID
- IMPLANTOPLASTY
- Conditions
- Peri-Implantitis, Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis treatment with implantoplasty | Experimental | Procedure: Implantoplasty, Procedure: Open flap debridement aloneOpen flap debridement with implantoplasty treatment |
| Peri-implantitis treatment without implantoplasty | Active comparator | Procedure: Implantoplasty, Procedure: Open flap debridement aloneOpen flap debridement withput implantoplasty treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantoplastyImplantoplasty 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 or surgery | Peri-implantitis treatment with implantoplasty, Peri-implantitis treatment without implantoplasty |
| Open flap debridement aloneOpen flap debridement alone | Procedure or surgery | Peri-implantitis treatment with implantoplasty, Peri-implantitis treatment without implantoplasty |
Primary outcome
Bleeding on probing
Time frame: 12 months after treatment
Measured with a periodontal probe
Bleeding on probing
Time frame: 24 months after treatment
Measured with a periodontal probe
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Oslo, Norway
Institute of Clinical Dentistry, University of Oslo, Norway
Oslo, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (time frame: 12 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.