Peri-implantitis Implantoplasty Treatment

NCT ID: NCT04052373

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2027-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Peri-Implantitis Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Peri-implantitis treatment with implantoplasty

Open flap debridement with implantoplasty treatment

Group Type EXPERIMENTAL

Implantoplasty

Intervention Type PROCEDURE

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 alone

Intervention Type PROCEDURE

Open flap debridement alone

Peri-implantitis treatment without implantoplasty

Open flap debridement withput implantoplasty treatment

Group Type ACTIVE_COMPARATOR

Implantoplasty

Intervention Type PROCEDURE

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 alone

Intervention Type PROCEDURE

Open flap debridement alone

Interventions

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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.

Intervention Type PROCEDURE

Open flap debridement alone

Open flap debridement alone

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Anders Verket

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Oslo, , Norway

Site Status RECRUITING

Institute of Clinical Dentistry, University of Oslo, Norway

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Facility Contacts

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Anders Verket, PhD

Role: primary

Odd Koldsland, PhD

Role: backup

Anders Verket, PhD

Role: primary

Other Identifiers

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IMPLANTOPLASTY

Identifier Type: -

Identifier Source: org_study_id