The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy

Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery

The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis; Periimplantitis
• Intervention / Treatment: Device: Chitosan brush

Detailed Description

Little is known about the effect of chair-side maintenance of dental implants after peri-implantitits surgery. Traditionally, the maintenance has been performed by titanium curettes to remove microbiological deposits from the submucosal area.

The Labrida biodegradable brush is a novel debridement device intended for use on dental implants. The concept of using a biodegradable material is related to the suggested problems with leaving remnants on the treated implant surface which would be negative from a bone regenerative aspect. The use of a flexible brush relates to the access problems when treating dental implants both related to the threads as well as due to the prosthetic supra construction hindering access for debridement with regular instruments developed for teeth. The material used in the brush will be Chitosan which is a natural polysaccharide, chitosan (poly-N-acetyl glucosaminoglycan), which is a nontoxic and bioabsorbable (REK-approval 2012/791 polymer).

H0: It is possible to maintain peri-implant health after surgical peri-implantitis treatment. There is no short- or long term clinical or radiographical differences between patients surgically treated for peri-implantitis maintained by the use of titanium cyrettes or with the Labrida brush in chair-side supportive care

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Overt peri-implantitis presenting at least one implant with;

• radiographic bone loss ≥ 2.0 mm
• bleeding on probing (BoP)

Main exclusion criteria:

• radiotherapy
• chemotherapy
• systemic long-term corticosteroid treatment
• pregnancy or nursing
• anatomical abnormalities
• history of previous treatment of peri-implantitis within 6 months after the screening
• American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery > 2

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: Test; Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes	Device: Chitosan brush; If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation; Other Names: Titanium curettes
Active Comparator: Control; Treatment/maintenance of implants postsurgically performed by the use of titanium curettes	Device: Chitosan brush; If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation; Other Names: Titanium curettes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation control	Absence/presence of bleeding on probing and deep peri-implant pockets	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive bone loss	Loss of attachment at the implant identified on radiographs	3 months

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Odd Carsten Koldsland, Ph.D, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 9, 2016
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

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; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: Peri-implantitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be handeled by the investigators treating the patients and collecting data

Drug and device information, study documents

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