Periodontal DiseasesNCT04173156
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
A study testing Labrida Bioclean and Gracey Periodontal curettes in people with Periodontal Diseases, run by Labrida AS at 3 sites in 2 countries.
Trial summary
40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Labrida Bioclean and Gracey Periodontal curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2017to 19 Dec 2019
- 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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Periodontitis as previously defined on at least three teeth but less than 8 teeth.
- 2. Above 18 years of age.
- 3. Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologist index (ASA) I and II).
- 4. Had full-mouth plaque scores ≤ 20% prior to final inclusion3 5. Signed Informed Consent obtained prior to start.
- 6. Psychological appropriateness 7. Consent to complete all follow-up visits
Who cannot join
- Prosthetic constructions with technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.
- Receiving systemic antibiotics < 3 months prior to study start.
- 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, in the opinion of the investigator, are incompatible with the protocol.
- Unwillingness to undergo treatment.
- Ongoing or previous radiotherapy to the head-neck region.
- Ongoing chemotherapy.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Turkey (Türkiye)1 site
Yeditetepe University; School of dentistry
Istanbul
About this study
Official title: Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.
Read the detailed description
2.3 This will be a prospective multicentre parallel arm randomized clinical trial of 6 months' duration. Clinical parameters of periodontal disease will be recorded at baseline and at 6 months. Radiographs will be taken at baseline and at 6 months.Treatment will be performed at baseline and thereafter every three months.
2.5 Study setting Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology at the test centres. Treatment will be performed by a registered separate therapist, either dentist or dental hygienist.
2.7 Treatment allocation Patients will be allocated to one of the following treatments: control (curettes+ ultrasound scaler (USS) supra and subgingivally), test (curettes + USS supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block randomization to ensure equal sample sizes.
- Conditions
- Periodontal Diseases
- Being tested
- Labrida Bioclean, Gracey Periodontal curettes
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labrida BiocleanDevice
Also called Gracey Periodontal curettes
The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan
Gracey Periodontal curettesDevice
Regular commercially available area specific and medical grade steel Gracey periodontal curettes
| Study group | Role | What they receive |
|---|---|---|
| Oscillating Chitosan Device | Experimental | 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 tooth. 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 |
| Regular Curettes | Active comparator | Standard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes Receives: Device: Gracey Periodontal curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups in clinical signs of inflammation
Difference between test and control groups in change in inflammation tested by measuring pocket probing depth (PPD) and Bleeding on Probing (BoP). Probing pocket depths will be recorded at 6 sites around each included tooth using a regular mm scale periodontal probe according to the examiners preferences. Bleeding on probing at the included sites will be assessed using a three-graded index within 30 seconds following probing of the pocket. A score of 0 represented no bleeding, 1 represented isolated minimal bleeding spots, 2 represented blood forming a confluent red line on the margin and 3 represented heavy or profuse bleeding This will be done to assess the clinical efficacy of the Labrida BioClean® biodegradable brush used as mechanical debridement device for treatment of advanced periodontal disease (2017 World Workshop Stage III and IV Grade B). Primary end-point is reduction in periodontal disease as measured clinically up to three months after therapy.
Measured: 6 months
Secondary outcomes (1)
Difference between groups in clinical and radiographic attachment loss
Difference between test and control groups in change in periodontal attachment loss tested by measuring clinical attachment loss and bone level differences on radiographs. This will be done to assess safety of Labrida BioClean® by evaluating the occurrence of adverse events. attachment level (CAL) measurements and radiographs. CAL will be assessed using a regular periodontal mm graded probe (Michigan O with Williams marking) with a force of approximately 20 N (experienced periodontal examiner). Bone attachement on intraoral radiographs at baseline and 6 and 12 months will be compared.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Oct 2017
- Primary completion15 Jun 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 79 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, Study director, Bjerke Tannmedisin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173156
- Sponsor's protocol ID
- 256756:2
- Status last verified
- Dec 2020
- First submitted
- 16 Aug 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04173156
- Acronym / sponsor ID
- 256756:2
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Labrida ASIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 21 Nov 2019 (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.
40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.
Detailed description
2.3 This will be a prospective multicentre parallel arm randomized clinical trial of 6 months' duration. Clinical parameters of periodontal disease will be recorded at baseline and at 6 months. Radiographs will be taken at baseline and at 6 months.Treatment will be performed at baseline and thereafter every three months.
2.5 Study setting Patient screening, inclusions and all clinical examinations will be performed by a board-certified specialist in periodontology at the test centres. Treatment will be performed by a registered separate therapist, either dentist or dental hygienist.
2.7 Treatment allocation Patients will be allocated to one of the following treatments: control (curettes+ ultrasound scaler (USS) supra and subgingivally), test (curettes + USS supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block randomization to ensure equal sample sizes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oscillating Chitosan Device | Experimental | Device: Labrida BiocleanThe 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 tooth. 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. |
| Regular Curettes | Active comparator | Device: Gracey Periodontal curettesStandard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Periodontitis as previously defined on at least three teeth but less than 8 teeth.
- 2. Above 18 years of age.
- 3. Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologist index (ASA) I and II).
- 4. Had full-mouth plaque scores ≤ 20% prior to final inclusion3 5. Signed Informed Consent obtained prior to start.
- 6. Psychological appropriateness 7. Consent to complete all follow-up visits
Key exclusion criteria (8 listed)
- Prosthetic constructions with technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.
- Receiving systemic antibiotics < 3 months prior to study start.
- 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, in the opinion of the investigator, are incompatible with the protocol.
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 BiocleanAlso: Gracey Periodontal curettesThe brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan | Device | Oscillating Chitosan Device |
| Gracey Periodontal curettesRegular commercially available area specific and medical grade steel Gracey periodontal curettes | Device | Regular Curettes |
Primary outcome
Difference between groups in clinical signs of inflammation
Time frame: 6 months
Difference between test and control groups in change in inflammation tested by measuring pocket probing depth (PPD) and Bleeding on Probing (BoP). Probing pocket depths will be recorded at 6 sites around each included tooth using a regular mm scale periodontal probe according to the examiners preferences. Bleeding on probing at the included sites will be assessed using a three-graded index within 30 seconds following probing of the pocket. A score of 0 represented no bleeding, 1 represented isolated minimal bleeding spots, 2 represented blood forming a confluent red line on the margin and 3 represented heavy or profuse bleeding This will be done to assess the clinical efficacy of the Labrida BioClean® biodegradable brush used as mechanical debridement device for treatment of advanced periodontal disease (2017 World Workshop Stage III and IV Grade B). Primary end-point is reduction in periodontal disease as measured clinically up to three months after therapy.
1 secondary outcome
Difference between groups in clinical and radiographic attachment loss
Time frame: 6 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 22 Dec 2020.
- 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 study director
Bjerke Tannmedisin
3 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 Gracey Periodontal curettes in people with Periodontal Diseases, run by Labrida AS at 3 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 5 inclusion and 8 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Turkey (Türkiye). 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?
Difference between groups in clinical signs of inflammation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2020.