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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07787962
Enrollment
40
Registered
2026-08-26
Start date
2026-10-01
Completion date
2027-01-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Survival Rate, Success

Keywords

medium term follow up of peri-implantitis treatment

Brief 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.

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.

Interventions

OTHERMedium-term follow-up of peri-implantitis treatment

clinical examination

Sponsors

The University of Western Australia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of implants with peri-implant healthminimum 6 yearsimplant 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

MeasureTime frameDescription
peri-implant probing depth (mm)minimum 6 yearsprobing depth at 4 sites per implant. Deepest peri-implant probing depth
peri-implant bleeding on probing (presence or absence)minimum 6 yearsnumber of sites with presence or absence of BOP
peri-implant suppuration (presence or absence)minimum 6 yearspresence or absence of suppuration on probing or palpation
peri-implant mucosal recession (mm)minimum 6 yearslevel of peri-implant mucosa measured from fixed a reference point as compared to baseline
radiographic marginal bone level (mm) compared to bone level at baselineminimum 6 yearsfrom intraoral radiograph
patient reported outcomes on VAS scale 0 - 100 mmminimum 6 yearsVAS 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.
radiographic marginal bone level ( mm) compared to 12 month marginal bone levelminimum 6 yearsmesial and distal radiographic marginal bone levels (mm) compared to the marginal bone levels at 12 months following treatment

Countries

Australia

Contacts

CONTACTLisa JA Heitz-Mayfield, Odont Dr
heitz.mayfield@iinet.net.au0402136899
PRINCIPAL_INVESTIGATORLisa Heitz-Mayfield, Odont Dr

Adjunct Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026