Peri-implantitis Implantoplasty Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorUniversity of Oslo
About this trial
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.
Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
Competent to give consent
Exposed, modified implant surface with loss >2mm
Disqualifiers
Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
Patients classified as > class II according to ASA classification
Implant unavailable for implantoplasty treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Implantoplasty
Procedure/SurgeryImplantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene.
Open flap debridement alone
Procedure/SurgeryOpen flap debridement alone
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Peri-implantitis treatment with implantoplastyExperimental treatment 2 interventions
Group B: Peri-implantitis treatment without implantoplastyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Bleeding on probing
Measured with a periodontal probe
Time frame
12 months after treatment2
Bleeding on probing
Measured with a periodontal probe
Time frame
24 months after treatmentSecondary outcomes
1
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Time frame
12 months after treatment2
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Time frame
24 months after treatment3
Pocket probing depth
Measured with a periodontal probe
Time frame
12 months after treatment4
Pocket probing depth
Measured with a periodontal probe
Time frame
24 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov