Peri-ImplantitisNCT03373448
Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device
A study testing Labrida BioClean and Titanium curettes in people with Peri-Implantitis, run by Labrida AS at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Labrida BioClean and Titanium curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Aug 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Norway3 sites
Spesdent
Oslo, 0352
Colosseum Majorstuen
Oslo, 0369
Bjerke Tannmedisin AS
Oslo, 0589
Sweden2 sites
Odontologiska Institutionen
Jönköping, 55111
Blekingesjukhuset
Karlskrona, 37185
About this study
Official title: Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device Versus Titanium Curettes - a Multicenter Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- Labrida BioClean, Titanium curettes
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labrida BioCleanDevice
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.
Titanium curettesOther
Peri-implant pockets will be debrided using titanium curettes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Labrida BioClean |
| Titanium curettes | Other | Peri-implant pockets will be debrided with titanium curettes. Receives: Other: Titanium curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Reduction in peri-implant mucositis as measured clinically up to three months after therapy.
Measured: 3 months after first treatment
Progression of bone loss
True end-point
Measured: 12 months after first treatment.
Secondary outcomes (2)
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.
Measured: 3 months
Adverse events
To assess safety of BioClean™ by evaluating the occurrence of adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Aug 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labrida AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Caspar Wohlfahrt, Labrida AS
- Investigators
- Caspar Wohlfahrt, PhD, Study director, Oslo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373448
- Sponsor's protocol ID
- 256756
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2017
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28497660
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device Versus Titanium Curettes - a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03373448
- Acronym / sponsor ID
- 256756
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Labrida ASIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Labrida BioClean | Active comparator | Device: Labrida BioCleanLabrida 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. |
| Titanium curettes | Other | Other: Titanium curettesPeri-implant pockets will be debrided with titanium curettes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labrida BioCleanThe 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. | Device | Labrida BioClean |
| Titanium curettesPeri-implant pockets will be debrided using titanium curettes. | Other | Titanium curettes |
Primary outcome
Inflammation
Time frame: 3 months after first treatment
Reduction in peri-implant mucositis as measured clinically up to three months after therapy.
Progression of bone loss
Time frame: 12 months after first treatment.
True end-point
2 secondary outcomes
Morbidity
Time frame: 3 months
Adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Results publication: PubMed 28497660Zeza 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caspar Wohlfahrt, PhD study director
Oslo University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labrida BioClean and Titanium curettes in people with Peri-Implantitis, run by Labrida AS at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation (time frame: 3 months after first treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.