Peri-implantitis Implantoplasty Treatment

University of Oslo

Status: Enrolling

Conditions: Peri-implant Mucositis; Peri-Implantitis

Treatments: Procedure: Open flap debridement alone; Procedure: Implantoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04052373

IMPLANTOPLASTY

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Inhability to comprehend and respond to the quality of life questionnaire
• Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
• History of peri-implantitis surgery prior to 6 months of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Peri-implantitis treatment with implantoplasty

Experimental group

Description:

Open flap debridement with implantoplasty treatment

Treatment:

Procedure: Open flap debridement alone

Procedure: Implantoplasty

Peri-implantitis treatment without implantoplasty

Active Comparator group

Description:

Open flap debridement withput implantoplasty treatment

Treatment:

Procedure: Open flap debridement alone

Procedure: Implantoplasty