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

Labrida AS

Status: Completed

Conditions: Periodontal Diseases

Treatments: Device: Gracey Periodontal curettes; Device: Labrida Bioclean

Study type: Interventional

Funder types: Industry

Identifiers

NCT04173156

256756:2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

  5. Psychological appropriateness 7. Consent to complete all follow-up visits

Exclusion criteria

1. 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.
2. Receiving systemic antibiotics < 3 months prior to study start.
3. Pregnant or lactating.
4. Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.
5. Presence of psychological characteristics such as inappropriate attitude or motivation which, in the opinion of the investigator, are incompatible with the protocol.
6. Unwillingness to undergo treatment.
7. Ongoing or previous radiotherapy to the head-neck region.
8. Ongoing chemotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

Oscillating Chitosan Device

Experimental group

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.

Treatment:

Device: Labrida Bioclean

Regular Curettes

Active Comparator group

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

Treatment:

Device: Gracey Periodontal curettes