Follow-up of a Randomised Controlled Study of Surgical Peri-implantitis Treatment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Western Australia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Medium-term follow-up of peri-implantitis treatment
Other interventionclinical examination
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: participants who have received surgical peri-implantitis treatment1 intervention
Trial outcomes
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 yearsSecondary outcomes
1
peri-implant probing depth (mm)
probing depth at 4 sites per implant. Deepest peri-implant probing depth
Time frame
minimum 6 years2
peri-implant bleeding on probing (presence or absence)
number of sites with presence or absence of BOP
Time frame
minimum 6 years3
peri-implant suppuration (presence or absence)
presence or absence of suppuration on probing or palpation
Time frame
minimum 6 years4
peri-implant mucosal recession (mm)
level of peri-implant mucosa measured from fixed a reference point as compared to baseline
Time frame
minimum 6 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: