Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device

NCT03373448 | Completed

• 1 other identifier: 256756
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 5

Brief Summary

34 patients diagnosed with mild to moderate peri-implantitis, defined as 2-4 mm peri-implant bone loss, will be randomized to either test treatment with Labrida BioClean® or control treatment with titanium curettes. In total 40 subjects (20 % drop-out rate), treated by 5 clinicians at 5 centers will be included in the study.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• Inflammation

  Reduction in peri-implant mucositis as measured clinically up to three months after therapy.

  3 months after first treatment

• Progression of bone loss

  True end-point

  12 months after first treatment.

Secondary Outcomes (2)

• Morbidity

  3 months

• Adverse events

  12 months

Study Arms (2)

Labrida BioClean

ACTIVE COMPARATOR

Labrida BioClean- chitosan device.The brush bristles of the test device (Labrida BioClean® LABRIDA AS, Oslo Norway) are made of the biopolymer chitosan. Any debris left from the chitosan bristles is completely biocompatible and will dissolve or be resorbed thus not causing harm to the tissues surrounding the implant. Chitosan is made from chitin derived from shell of marine crustaceans such as shrimp and crab, however chemically modified and thus not even considered to be animally derived. Chitosan has been approved for use in e.g., surgical bandages, as a haemostatic agent and as dietary supplement used in a wide range of nutritional and health products. Chitosan has also been documented to be non-allergenic and it has been suggested that chitosan has anti-inflammatory properties.

Device: Labrida BioClean

Titanium curettes

OTHER

Peri-implant pockets will be debrided with titanium curettes.

Other: Titanium curettes

Interventions

Labrida BioClean DEVICE

The implant pockets will be debrided with the BioClean™ biodegradable brush for 2 minutes and with the brush seated in an oscillating dental handpiece (NSK ESQ10 TEQ) and thereafter irrigated with sterile saline or commercially available and area-specific titanium curettes (Langer and Langer, Rønvig) for 2 minutes and thereafter irrigated with sterile saline. The treatment will be repeated every three months until the terminal examination after 24 months. Debridement is performed with local anaesthesia as needed. Healthy sites will not be retreated.

Labrida BioClean

Titanium curettes OTHER

Peri-implant pockets will be debrided using titanium curettes.

Titanium curettes

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peri-implantitis defined as 2-4 mm bone loss distally, mesially or both, Probing Pocket Depth (PPD) ≥4mm and inflammation as demonstrated by Bleeding on Probing (mBoP) at least score 2.
• Peri-implantitis as defined above on an implant that has been in function for more than 12 months prior to study start.
• Above 18 years of age.
• Eligible for treatment in an outpatient dental clinic (ie, ASA I and II).
• Had at least one implant with a loading time of ≥ 12 months prior to baseline.
• Signed Informed Consent obtained prior to start.
• Psychological appropriateness.
• Consent to complete all follow-up visits.

You may not qualify if:

• Peri-implant bone loss \> 4 mm, radiotherapy, chemotherapy, systemic long-term corticosteroid treatment, pregnancy or nursing, anatomical abnormalities, prosthetic factors making access to clinical measurements impossible.
• Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements.
• Mobile implant.
• Patients diagnosed with periodontal disease must have undergone causative treatment and be re-evaluated.
• Implants previously treated for peri-implantitis with grafting materials.
• Receiving medications known to induce mucosal hyperplasia.
• Uncontrolled diabetes HbA1c \> 52, equals 7.0.
• Pregnant or lactating.
• Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.
• Presence of psychological characteristics, such as inappropriate attitude or motivation, which will influence treatment execution and treatment outcome.
• Unwillingness to undergo treatment.
• Advanced, untreated and uncontrolled peri-implantitis on neighbouring implants.
• If, in the opinion of the therapist, conditions are such that dental implants are deemed failing.
• Ongoing or previous radiotherapy to the head-neck region.
• Ongoing or previous chemotherapy.

Sponsors & Collaborators

• Labrida AS: lead

Study Sites (5)

Spesdent

Oslo, 0352, Norway

Location

Colosseum Majorstuen

Oslo, 0369, Norway

Location

Bjerke Tannmedisin AS

Oslo, 0589, Norway

Location

Odontologiska Institutionen

Jönköping, 55111, Sweden

Location

Blekingesjukhuset

Karlskrona, 37185, Sweden

Location

Related Publications (1)

• Zeza B, Wohlfahrt C, Pilloni A. Chitosan brush for professional removal of plaque in mild peri-implantitis. Minerva Stomatol. 2017 Aug;66(4):163-168. doi: 10.23736/S0026-4970.17.04040-7. Epub 2017 May 10.

  PMID: 28497660 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Caspar Wohlfahrt, PhD

  Oslo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Examiners blinded to treatment allocation since treatment is performed by a dental hygienist.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist i periodontology

Model Details: Patients will be allocated either to test (Labrida BioClean® or control (titanium curettes) treatment by computer-generated block randomization to ensure equal sample sizes. The examiners will be blinded to the treatment allocation.

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); NO (3)