Clinical trial NCT04173156: Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Official title: Treatment of Localized Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone - a Randomized Parallel Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Labrida AS
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference between groups in clinical signs of inflammation
timeFrame: 6 months
Secondary outcomes:
measure: Difference between groups in clinical and radiographic attachment loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Bjerke tannmedisin
city: Stavanger
country: Norway
facility: Colosseum Sola
city: Istanbul
country: Turkey
facility: Yeditetepe University; School of dentistry
Study officials:
affiliation: Bjerke Tannmedisin
name: Caspar Wohlfahrt
role: STUDY_DIRECTOR
References: