Peri-implantitis Implantoplasty Treatment

Not Applicable

Recruiting

• Conditions: Peri-Implantitis; Peri-implant Mucositis
• Interventions: Procedure: Implantoplasty; Procedure: Open flap debridement alone

• Registration Number: NCT04052373
• Lead Sponsor: University of Oslo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-09
• Study Start: 2019-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2027-06-15
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peri-implantitis treatment with implantoplasty	Open flap debridement alone	Open flap debridement with implantoplasty treatment
Peri-implantitis treatment with implantoplasty	Implantoplasty	Open flap debridement with implantoplasty treatment
Peri-implantitis treatment without implantoplasty	Implantoplasty	Open flap debridement withput implantoplasty treatment
Peri-implantitis treatment without implantoplasty	Open flap debridement alone	Open flap debridement withput implantoplasty treatment

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	24 months after treatment	Measured with a periodontal probe

Secondary Outcome Measures

Name	Time	Method
Clinical attachment loss measurements	24 months after treatment	Measured with a periodontal probe
Radiographic bone loss	24 months after treatment	Measured on standardized radiograps
Implant fracture	24 months	Clinical examination to assess whether implants have fractured following treatment
Suppuration	24 months after treatment	Visible suppuration upon probing the implant with a periodontal probe
Pocket probing depth	24 months after treatment	Measured with a periodontal probe
Changes in patient-reported quality of life (QoL)	Preoperatively compared to 24 months after treatment	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)

Trial Locations

Locations (2)

Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo; 🇳🇴 Oslo, Norway

Institute of Clinical Dentistry, University of Oslo, Norway; 🇳🇴 Oslo, Norway