NCT04052373

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2019Jun 2027

First Submitted

Initial submission to the registry

August 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7.7 years

First QC Date

August 6, 2019

Last Update Submit

April 28, 2026

Conditions

Peri-ImplantitisPeri-implant Mucositis

Outcome Measures

Primary Outcomes (2)

  • Bleeding on probing

    Measured with a periodontal probe

    12 months after treatment

  • Bleeding on probing

    Measured with a periodontal probe

    24 months after treatment

Secondary Outcomes (10)

  • Suppuration

    12 months after treatment

  • Suppuration

    24 months after treatment

  • Pocket probing depth

    12 months after treatment

  • Pocket probing depth

    24 months after treatment

  • Changes in patient-reported quality of life (QoL)

    Preoperatively compared to 24 months after treatment

  • +5 more secondary outcomes

Study Arms (2)

Peri-implantitis treatment with implantoplasty

EXPERIMENTAL

Open flap debridement with implantoplasty treatment

Procedure: ImplantoplastyProcedure: Open flap debridement alone

Peri-implantitis treatment without implantoplasty

ACTIVE COMPARATOR

Open flap debridement withput implantoplasty treatment

Procedure: ImplantoplastyProcedure: Open flap debridement alone

Interventions

ImplantoplastyPROCEDURE

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.

Peri-implantitis treatment with implantoplastyPeri-implantitis treatment without implantoplasty
Open flap debridement alonePROCEDURE

Open flap debridement alone

Peri-implantitis treatment with implantoplastyPeri-implantitis treatment without implantoplasty

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 9, 2019

Study Start

October 15, 2019

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

NO(2)