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

NCT ID: NCT04173156

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-12-19

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oscillating 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 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.

Group Type: EXPERIMENTAL

Labrida Bioclean

Intervention Type: DEVICE

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

Regular Curettes

Standard non surgical treatment of active periodontal disease includes supra and subgingival scaling and root planing with periodontal medical grade Gracey system steel curettes

Group Type: ACTIVE_COMPARATOR

Gracey Periodontal curettes

Intervention Type: DEVICE

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

Interventions

Labrida Bioclean

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

Intervention Type: DEVICE

Gracey Periodontal curettes

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

Intervention Type: DEVICE

Other Intervention Names

Gracey Periodontal curettes

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Labrida AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Caspar Wohlfahrt

Specialist in periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caspar Wohlfahrt

Role: STUDY_DIRECTOR

Bjerke Tannmedisin

Locations

Bjerke tannmedisin

Oslo, , Norway

Colosseum Sola

Stavanger, , Norway

Yeditetepe University; School of dentistry

Istanbul, , Turkey (Türkiye)

Countries

Norway; Turkey (Türkiye)

Other Identifiers

256756:2

Identifier Type: -

Identifier Source: org_study_id