SuccessNCT07787962
Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment
An observational study of Success and Dental Implant Survival Rate, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Success, Dental Implant Survival Rate
- What is being tested?
- Medium-term follow-up of peri-implantitis treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- individuals who were not enrolled in the previous study ID 37382408
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
The University of Western Australia
Perth, Western Australia, 6009
About this study
Official title: 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.
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.
- Conditions
- Success, Dental Implant Survival Rate
- Being tested
- Medium-term follow-up of peri-implantitis treatment
- Keywords
- medium term follow up of peri-implantitis treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-term follow-up of peri-implantitis treatmentOther
clinical examination
| Study group | Role | What they receive |
|---|---|---|
| participants who have received surgical peri-implantitis treatment | 6 -9 year follow-up after treatment of peri-implantitis Receives: Other: Medium-term follow-up of peri-implantitis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minimum 6 years
Secondary outcomes (7)
peri-implant probing depth (mm)
probing depth at 4 sites per implant. Deepest peri-implant probing depth
Measured: minimum 6 years
peri-implant bleeding on probing (presence or absence)
number of sites with presence or absence of BOP
Measured: minimum 6 years
peri-implant suppuration (presence or absence)
presence or absence of suppuration on probing or palpation
Measured: minimum 6 years
peri-implant mucosal recession (mm)
level of peri-implant mucosa measured from fixed a reference point as compared to baseline
Measured: minimum 6 years
radiographic marginal bone level (mm) compared to bone level at baseline
from intraoral radiograph
Measured: minimum 6 years
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.
Measured: minimum 6 years
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
Measured: minimum 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Heitz-Mayfield, The University of Western Australia
- Investigators
- Lisa Heitz-Mayfield, Odont Dr, Principal investigator, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787962
- Sponsor's protocol ID
- 2021/ET001133
- Other IDs
- 2021/ET001133
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Follow-up of a Randomised Controlled Study Evaluating Reconstructive Peri-implantitis Treatment
- ClinicalTrials.gov ID
- NCT07787962
- Acronym / sponsor ID
- 2021/ET001133
- Conditions
- Success, Dental Implant Survival Rate
- Keywords
- medium term follow up of peri-implantitis treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants who have received surgical peri-implantitis treatment | – | Other: Medium-term follow-up of peri-implantitis treatment6 -9 year follow-up after treatment of peri-implantitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- individuals who were not enrolled in the previous study ID 37382408
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium-term follow-up of peri-implantitis treatmentclinical examination | Other | participants who have received surgical peri-implantitis treatment |
Primary outcome
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
7 secondary outcomes
peri-implant probing depth (mm)
Time frame: minimum 6 years
peri-implant bleeding on probing (presence or absence)
Time frame: minimum 6 years
peri-implant suppuration (presence or absence)
Time frame: minimum 6 years
peri-implant mucosal recession (mm)
Time frame: minimum 6 years
radiographic marginal bone level (mm) compared to bone level at baseline
Time frame: minimum 6 years
patient reported outcomes on VAS scale 0 - 100 mm
Time frame: minimum 6 years
radiographic marginal bone level ( mm) compared to 12 month marginal bone level
Time frame: minimum 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Results publication: PubMed 37382408Heitz-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Heitz-Mayfield, Odont Dr principal investigator
Adjunct Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Success and Dental Implant Survival Rate, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa JA Heitz-Mayfield, Odont Dr (0402136899, heitz.mayfield@iinet.net.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of implants with peri-implant health (time frame: minimum 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.