Back to resultsTreatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Labrida Bioclean
Gracey Periodontal curettes
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Sites / Locations
- Bjerke tannmedisin
- Colosseum Sola
- Yeditetepe University; School of dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oscillating Chitosan Device
Regular Curettes
Arm Description
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.
Standard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04173156
Brief Title
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Official Title
Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
December 19, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Examiners blinded to treatment allocation
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oscillating Chitosan Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular Curettes
Arm Type
Active Comparator
Arm Description
Standard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes
Intervention Type
Device
Intervention Name(s)
Labrida Bioclean
Other Intervention Name(s)
Gracey Periodontal curettes
Intervention Description
The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan
Intervention Type
Device
Intervention Name(s)
Gracey Periodontal curettes
Intervention Description
Regular commercially available area specific and medical grade steel Gracey periodontal curettes
Primary Outcome Measure Information:
Title
Difference between groups in clinical signs of inflammation
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference between groups in clinical and radiographic attachment loss
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caspar Wohlfahrt
Organizational Affiliation
Bjerke Tannmedisin
Official's Role
Study Director
Facility Information:
Facility Name
Bjerke tannmedisin
City
Oslo
ZIP/Postal Code
0286
Country
Norway
Facility Name
Colosseum Sola
City
Stavanger
Country
Norway
Facility Name
Yeditetepe University; School of dentistry
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
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