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NCT Number: NCT07787962

Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment

This study is a medium-term (6-9 years) follow-up of the health of the tissues surrounding the implant which was treated for peri-implantitis (peri-implant infection) in an already completed study with a 12 month follow-up. Patients who were treated in a randomised controlled trial with a 12 month follow-up will be invited to attend for examination of the implant and an x-ray to assess the bone levels at the implant. Participants will be asked to complete a questionnaire about their overall satisfaction following treatment.

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Key information

Conditions

Success Dental Implant Survival Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Western Australia

Perth, Western Australia, 6009, Australia

About this study

Follow-up of 40 participants who were already enrolled in a randomised controlled trial comparing access flap with and without guided bone regeneration for the treatment of peri-implantitis. The 12 month outcomes have been published. doi: 10.1111/clr.14116 This study will provide a medium term (6-9 years) follow-up of the participants Participants will be invited to attend an examination.

Full mouth probing Full mouth bleeding and plaque scores Peri-implant probing depth and recession measurements at the treated implant An intraoral radiograph to evaluate marginal bone levels at the treated implant Questionnaire to evaluate satisifaction with the treatment

Participants will receive maintenance care at the treated implant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • participants from the previous study ID 37382408
  • participants from the previous study who were treated for peri-implantitis either with access flap or access flap and graft material + barrier membrane.

Exclusion criteria

  • individuals who were not enrolled in the previous study ID 37382408

Treatment and study plan

Medium-term follow-up of peri-implantitis treatment

Other

clinical examination

Primary outcomes

  1. Number of implants with peri-implant health

    Time frame: minimum 6 years

    implant present + peri-implant probing depths ≤ 5 mm + absence of bleeding BOP ( 1 spot of bleeding allowed) + absence suppuration + no additional bone loss as compared to baseline measures

Secondary outcomes

  1. peri-implant probing depth (mm)

    Time frame: minimum 6 years

    probing depth at 4 sites per implant. Deepest peri-implant probing depth

  2. peri-implant bleeding on probing (presence or absence)

    Time frame: minimum 6 years

    number of sites with presence or absence of BOP

  3. peri-implant suppuration (presence or absence)

    Time frame: minimum 6 years

    presence or absence of suppuration on probing or palpation

  4. peri-implant mucosal recession (mm)

    Time frame: minimum 6 years

    level of peri-implant mucosa measured from fixed a reference point as compared to baseline

  5. radiographic marginal bone level (mm) compared to bone level at baseline

    Time frame: minimum 6 years

    from intraoral radiograph

  6. patient reported outcomes on VAS scale 0 - 100 mm

    Time frame: minimum 6 years

    VAS questionnaires - regarding overall satisfaction with appearance of implant following treatment, overall satisfaction with implant treatment, Would you have had an implant if you had known you would need the treatment. Do you have pain at the implant site, do you have a bad taste from the implant site.

  7. radiographic marginal bone level ( mm) compared to 12 month marginal bone level

    Time frame: minimum 6 years

    mesial and distal radiographic marginal bone levels (mm) compared to the marginal bone levels at 12 months following treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa JA Heitz-Mayfield, Odont Dr

CONTACT

[email protected]

0402136899

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Registry information

Official study title

Medium-term Follow-up of a Randomised Controlled Study Evaluating Reconstructive Peri-implantitis Treatment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 28, 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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