Trials / Completed
CompletedNCT04173156
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Labrida AS · Industry
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Labrida Bioclean | The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan |
| DEVICE | Gracey Periodontal curettes | Regular commercially available area specific and medical grade steel Gracey periodontal curettes |
Timeline
- Start date
- 2017-10-01
- Primary completion
- 2019-06-15
- Completion
- 2019-12-19
- First posted
- 2019-11-21
- Last updated
- 2020-12-22
Locations
3 sites across 2 countries: Norway, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04173156. Inclusion in this directory is not an endorsement.