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Not yet recruitingNCT07787962Updated Aug 28, 2026

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

An observational study in Success and Dental Implant Survival Rate, sponsored by The University of Western Australia. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by The University of Western Australia · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Success
  • Dental Implant Survival Rate

Keywords

  • medium term follow up of peri-implantitis treatment
03

In context

Lead sponsor

The University of Western Australia is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants from the original RCT ID 37382408. Participants of the randomised controlled study for the regenerative treatment of peri-implantitis who still have their implant in situ

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • participants who have received surgical peri-implantitis treatment

    6 -9 year follow-up after treatment of peri-implantitis

    Other: Medium-term follow-up of peri-implantitis treatment

Interventions

  • OtherMedium-term follow-up of peri-implantitis treatment

    clinical examination

06

What researchers measure

Primary outcomes

  1. Number of implants with peri-implant health

    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

    Time frame: minimum 6 years

Secondary outcomes

  1. peri-implant probing depth (mm)

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

    Time frame: minimum 6 years

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

    number of sites with presence or absence of BOP

    Time frame: minimum 6 years

  3. peri-implant suppuration (presence or absence)

    presence or absence of suppuration on probing or palpation

    Time frame: minimum 6 years

  4. peri-implant mucosal recession (mm)

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

    Time frame: minimum 6 years

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

    from intraoral radiograph

    Time frame: minimum 6 years

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

    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.

    Time frame: minimum 6 years

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

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

    Time frame: minimum 6 years

07

Study locations

1 site
08

References and documents

Publications

  • Heitz-Mayfield LJA, Heitz F, Koong B, Huang T, Chivers P. Surgical peri-implantitis treatment with and without guided bone regeneration. A randomized controlled trial. Clin Oral Implants Res. 2023 Sep;34(9):892-910. doi: 10.1111/clr.14116. Epub 2023 Jun 29. PubMed 37382408 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Aug 26, 2026
StartEst.
Oct 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07787962
Lead sponsor
The University of Western Australia
Responsible party
Lisa Heitz-Mayfield (Adjunct Professor, The University of Western Australia) — Principal investigator
First posted
Aug 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Lisa JA Heitz-Mayfield, Odont Dr
Contact
heitz.mayfield@iinet.net.au
0402136899
Lisa Heitz-Mayfield, Odont Dr
principal investigator · Adjunct Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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