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

Primary Purpose

Peri-Implantitis

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Labrida BioClean

Titanium curettes

About this trial

This is an interventional supportive care trial for Peri-Implantitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

In addition to the above mentioned main inclusion criteria, patients can be included if they meet the following conditions:

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 full-mouth plaque scores ≤20% prior to final inclusion and no visual plaque at the included implants prior to study start.
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.

Exclusion Criteria:

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.

In addition to the above mentioned main exclusion criteria, patients should be excluded if they meet any of the following conditions:

Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements.
Technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.
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.
Receiving systemic antibiotics < 3 months prior to inclusion.
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.
Systemic long-term corticosteroid treatment.
Patients medicating with warfarine products or similar.
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Sites / Locations

Spesdent
Colosseum Majorstuen
Bjerke Tannmedisin AS
Odontologiska Institutionen
Blekingesjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Labrida BioClean

Titanium curettes

Arm Description

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.

Peri-implant pockets will be debrided with titanium curettes.

Outcomes

Primary Outcome Measures

Inflammation

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

Progression of bone loss

True end-point

Secondary Outcome Measures

Morbidity

To compare patient morbidity after use of Labrida BioClean® versus titanium curettes determined on a VAS scale assessed at the 3 month treatment visit.

Adverse events

To assess safety of BioClean™ by evaluating the occurrence of adverse events.

Full Information

NCT ID

NCT03373448

First Posted

December 8, 2017

Last Updated

October 20, 2022

Sponsor

Labrida AS

1. Study Identification

Unique Protocol Identification Number

NCT03373448

Brief Title

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

Official Title

Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device Versus Titanium Curettes - a Multicenter Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Labrida AS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

4.1 Study design The study will be a prospective multicentre randomized, examiner blinded controlled clinical trial of 24 months duration. Change in mucosal inflammation will be reported after 6 months while the true endpoint parameters i.e., peri-implant attachment will be reported after 1 and 2 years. 4.2 Treatment allocation and blinding 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. 4.3 Study setting In total six centres will be included. Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology, registered dental hygienist or specialist in prosthetics at each centre. Treatments will be performed by a dental hygienist or a board-certified specialist in periodontology. 4.4 Patients 40 patients (20+20) diagnosed with mild to moderate peri-implantitis, defined as peri-implant bone loss 2 -4 mm, will be included in the study. 4.5 Recruitment of patients Patients referred to or seeking care in the included clinics will be screened for inclusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-Implantitis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

InvestigatorOutcomes Assessor

Masking Description

Examiners blinded to treatment allocation since treatment is performed by a dental hygienist.

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Labrida BioClean

Arm Type

Active Comparator

Arm Description

Arm Title

Titanium curettes

Arm Type

Other

Arm Description

Peri-implant pockets will be debrided with titanium curettes.

Intervention Type

Device

Intervention Name(s)

Labrida BioClean

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Titanium curettes

Intervention Description

Peri-implant pockets will be debrided using titanium curettes.

Primary Outcome Measure Information:

Title

Inflammation

Description

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

Time Frame

3 months after first treatment

Title

Progression of bone loss

Description

True end-point

Time Frame

12 months after first treatment.

Secondary Outcome Measure Information:

Title

Morbidity

Description

To compare patient morbidity after use of Labrida BioClean® versus titanium curettes determined on a VAS scale assessed at the 3 month treatment visit.

Time Frame

3 months

Title

Adverse events

Description

To assess safety of BioClean™ by evaluating the occurrence of adverse events.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. In addition to the above mentioned main inclusion criteria, patients can be included if they meet the following conditions: 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 full-mouth plaque scores ≤20% prior to final inclusion and no visual plaque at the included implants prior to study start. 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. Exclusion Criteria: 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. In addition to the above mentioned main exclusion criteria, patients should be excluded if they meet any of the following conditions: Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements. Technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion. 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. Receiving systemic antibiotics < 3 months prior to inclusion. 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. Systemic long-term corticosteroid treatment. Patients medicating with warfarine products or similar. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caspar Wohlfahrt, PhD

Organizational Affiliation

Oslo University

Official's Role

Study Director

Facility Information:

Facility Name

Spesdent

City

Oslo

ZIP/Postal Code

0352

Country

Norway

Facility Name

Colosseum Majorstuen

City

Oslo

ZIP/Postal Code

0369

Country

Norway

Facility Name

Bjerke Tannmedisin AS

City

Oslo

ZIP/Postal Code

0589

Country

Norway

Facility Name

Odontologiska Institutionen

City

Jönköping

ZIP/Postal Code

55111

Country

Sweden

Facility Name

Blekingesjukhuset

City

Karlskrona

ZIP/Postal Code

37185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28497660

Citation

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.

Results Reference

result

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

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