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

Periodontal Diseases Clinical Trial

Official title:

Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173156
• Other study ID #: 256756:2
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 19, 2019

Study information

• Verified date: December 2020
• Source: Labrida AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 19, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Device:
• Labrida Bioclean
The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan
• Gracey Periodontal curettes
Regular commercially available area specific and medical grade steel Gracey periodontal curettes

Locations

Country	Name	City	State
Norway	Bjerke tannmedisin	Oslo
Norway	Colosseum Sola	Stavanger
Turkey	Yeditetepe University; School of dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Labrida AS

Countries where clinical trial is conducted

Norway,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months