Peri-implantitis Implantoplasty Treatment

Surgical Peri-implantitis Treatment With and Without Implantoplasty

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 Overview

• Status: Recruiting
• Conditions: Peri-Implantitis; Peri-implant Mucositis
• Intervention / Treatment: Procedure: Implantoplasty; Procedure: Open flap debridement alone

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0455
    • Recruiting
    • Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
    • Contact: Anders Verket, PhD; Phone Number: +47 93667661; Email: anderver@odont.uio.no
    • Contact: Odd Koldsland, PhD; Phone Number: +47 93098618; Email: oddcko@odont.uio.no
  • Oslo, Norway
    • Recruiting
    • Institute of Clinical Dentistry, University of Oslo, Norway
    • Contact: Anders Verket, PhD; Phone Number: +47 22852064; Email: anderver@odont.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peri-implantitis treatment with implantoplasty; Open flap debridement with implantoplasty treatment	Procedure: Implantoplasty; 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.; Procedure: Open flap debridement alone; Open flap debridement alone
Active Comparator: Peri-implantitis treatment without implantoplasty; Open flap debridement withput implantoplasty treatment	Procedure: Implantoplasty; 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.; Procedure: Open flap debridement alone; Open flap debridement alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing	Measured with a periodontal probe	12 months after treatment
Bleeding on probing	Measured with a periodontal probe	24 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suppuration	Visible suppuration upon probing the implant with a periodontal probe	12 months after treatment
Suppuration	Visible suppuration upon probing the implant with a periodontal probe	24 months after treatment
Pocket probing depth	Measured with a periodontal probe	12 months after treatment
Pocket probing depth	Measured with a periodontal probe	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)	Preoperatively compared to 24 months after treatment
Clinical attachment loss measurements	Measured with a periodontal probe	12 months after treatment
Clinical attachment loss measurements	Measured with a periodontal probe	24 months after treatment
Radiographic bone loss	Measured on standardized radiograps	12 months after treatment
Radiographic bone loss	Measured on standardized radiograps	24 months after treatment
Implant fracture	Clinical examination to assess whether implants have fractured following treatment	24 months

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Mucositis; Peri-Implantitis
• Other Study ID Numbers: IMPLANTOPLASTY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No