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NCT Number: NCT04052373

Peri-implantitis Implantoplasty Treatment

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Peri-implant Mucositis Periodontal Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantoplasty

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

Procedure

Open flap debridement alone

Primary outcomes

  1. Bleeding on probing

    Time frame: 12 months after treatment

    Measured with a periodontal probe

  2. Bleeding on probing

    Time frame: 24 months after treatment

    Measured with a periodontal probe

Secondary outcomes

  1. Suppuration

    Time frame: 12 months after treatment

    Visible suppuration upon probing the implant with a periodontal probe

  2. Suppuration

    Time frame: 24 months after treatment

    Visible suppuration upon probing the implant with a periodontal probe

  3. Pocket probing depth

    Time frame: 12 months after treatment

    Measured with a periodontal probe

  4. Pocket probing depth

    Time frame: 24 months after treatment

    Measured with a periodontal probe

  5. Changes in patient-reported quality of life (QoL)

    Time frame: Preoperatively compared to 24 months after treatment

    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)

  6. Clinical attachment loss measurements

    Time frame: 12 months after treatment

    Measured with a periodontal probe

  7. Clinical attachment loss measurements

    Time frame: 24 months after treatment

    Measured with a periodontal probe

  8. Radiographic bone loss

    Time frame: 12 months after treatment

    Measured on standardized radiograps

  9. Radiographic bone loss

    Time frame: 24 months after treatment

    Measured on standardized radiograps

  10. Implant fracture

    Time frame: 24 months

    Clinical examination to assess whether implants have fractured following treatment

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

Surgical Peri-implantitis Treatment With and Without Implantoplasty

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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