Peri-implantitis Implantoplasty Treatment

University of Oslo35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peri-Implantitis Peri-implant Mucositis

Interventions

ImplantoplastyPROCEDURE

Implantoplasty 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 alonePROCEDURE

Open flap debridement alone

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Oslo, Oslo, Norway

RECRUITING

Institute of Clinical Dentistry, University of Oslo, Norway

Oslo, Norway

RECRUITING

Outcomes

Primary Outcomes

Bleeding on probing

Measured with a periodontal probe

Time frame: 12 months after treatment

Bleeding on probing

Measured with a periodontal probe

Time frame: 24 months after treatment

Secondary Outcomes

Suppuration

Visible suppuration upon probing the implant with a periodontal probe

Time frame: 12 months after treatment

Suppuration

Visible suppuration upon probing the implant with a periodontal probe

Time frame: 24 months after treatment

Pocket probing depth

Measured with a periodontal probe

Time frame: 12 months after treatment

Pocket probing depth

Measured with a periodontal probe

Time frame: 24 months after treatment

Changes in patient-reported quality of life (QoL)

To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)

Time frame: Preoperatively compared to 24 months after treatment

Data from ClinicalTrials.gov

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