Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT04173156
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Sponsor:
Labrida AS
Organization:
Study Overview
Official Title:
Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: