Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment
August 25, 2026 updated by: Lisa Heitz-Mayfield, The University of Western Australia
Medium-term Follow-up of a Randomised Controlled Study Evaluating Reconstructive 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa JA Heitz-Mayfield, Odont Dr
- Phone Number: 0402136899
- Email: heitz.mayfield@iinet.net.au
Study Locations
-
-
Western Australia
-
Perth, Western Australia, Australia, 6009
- The University of Western Australia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
participants who have received surgical peri-implantitis treatment
6 -9 year follow-up after treatment of peri-implantitis
|
clinical examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
minimum 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peri-implant probing depth (mm)
Time Frame: minimum 6 years
|
probing depth at 4 sites per implant.
Deepest peri-implant probing depth
|
minimum 6 years
|
|
peri-implant bleeding on probing (presence or absence)
Time Frame: minimum 6 years
|
number of sites with presence or absence of BOP
|
minimum 6 years
|
|
peri-implant suppuration (presence or absence)
Time Frame: minimum 6 years
|
presence or absence of suppuration on probing or palpation
|
minimum 6 years
|
|
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
|
minimum 6 years
|
|
radiographic marginal bone level (mm) compared to bone level at baseline
Time Frame: minimum 6 years
|
from intraoral radiograph
|
minimum 6 years
|
|
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.
|
minimum 6 years
|
|
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
|
minimum 6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa Heitz-Mayfield, Odont Dr, Adjunct Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
August 23, 2026
First Submitted That Met QC Criteria
August 23, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 25, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2021/ET001133 (Other Identifier: University of Western Australia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.