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

NCT07787962 | Not Yet Recruiting

• 1 other identifier: 2021/ET001133
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Success; Dental Implant Survival Rate

Keywords

medium term follow up of peri-implantitis treatment

Outcome Measures

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

  minimum 6 years

Secondary Outcomes (7)

• peri-implant probing depth (mm)

  minimum 6 years

• peri-implant bleeding on probing (presence or absence)

  minimum 6 years

• peri-implant suppuration (presence or absence)

  minimum 6 years

• peri-implant mucosal recession (mm)

  minimum 6 years

• radiographic marginal bone level (mm) compared to bone level at baseline

  minimum 6 years

Study Arms (1)

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

Medium-term follow-up of peri-implantitis treatment OTHER

clinical examination

participants who have received surgical peri-implantitis treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Western Australia: lead

Study Sites (1)

The University of Western Australia

Perth, Western Australia, 6009, Australia

Location

Related Publications (1)

• 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.

  PMID: 37382408 RESULT

Study Officials

• Lisa Heitz-Mayfield, Odont Dr

  Adjunct Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa JA Heitz-Mayfield, Odont Dr

CONTACT

0402136899; heitz.mayfield@iinet.net.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

AU (1)