Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone

NCT04173156 | Completed

• 1 other identifier: 256756:2
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 3

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Difference between groups in clinical and radiographic attachment loss

  6 months

Study Arms (2)

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.

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

Device: Gracey Periodontal curettes

Interventions

Labrida Bioclean DEVICE

The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan

Also known as: Gracey Periodontal curettes

Oscillating Chitosan Device

Gracey Periodontal curettes DEVICE

Regular commercially available area specific and medical grade steel Gracey periodontal curettes

Regular Curettes

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Periodontitis as previously defined on at least three teeth but less than 8 teeth.
• \. Above 18 years of age.
• \. Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologist index (ASA) I and II).
• \. Psychological appropriateness 7. Consent to complete all follow-up visits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Labrida AS: lead

Study Sites (3)

Bjerke tannmedisin

Oslo, 0286, Norway

Location

Colosseum Sola

Stavanger, Norway

Location

Yeditetepe University; School of dentistry

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Caspar Wohlfahrt

  Bjerke Tannmedisin

  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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in periodontology

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: November 21, 2019
• Study Start: October 1, 2017
• Primary Completion: June 15, 2019
• Study Completion: December 19, 2019
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); NO (2)