Clinical trial NCT02391974: Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets
Official title: Filling of Periodontal Pockets With a Commercially Available Injectable Cross-linked Hyaluronic Acid Dental Filler Versus Oral Hygiene Alone, After Scaling and Root Planing and Chlorhexidine Disinfection, for the Treatment of Periodontitis: A Single-blinded, Multi Center, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Hyaluronic acid
Periodontal pockets
Periodontitis
Lead sponsor: Teoxane SA
Sponsor class: INDUSTRY
Collaborators: name: Syneed Medidata GmbH
First posted: 2015-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled, randomized, single-blinded, multicenter, prospective clinical study.

In addition to the standard periodontal treatment procedure on all teeth that need to be treated, the 4 teeth with the deepest pockets (between 4 and 6 mm) will be randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

The pocket depth will be measured at six sites around each tooth, and only the deepest pocket sites of each tooth will be taken into account.

Detailed description: This is a controlled, randomized, single-blinded (independent Blinded Evaluator), multicenter, prospective clinical study.

Each subject will receive the standard periodontal treatment procedure on all teeth that need to be treated. The usual cares are scaling and root planing (SRP), and chlorhexidine, and instructions to oral hygiene (proper brushing techniques twice a day, proper flossing technique daily, and prevention : sugar intake, alcohol consumption, fluoride level).

Two other optional treatment sessions with SRP could be performed, if deemed necessary by the Treating Investigator. Those optional SRP session could only be performed after all study-related clinical assessement.

The pocket depth of every teeth will be measured at six sites around each tooth, and only the deepest pocket sites will be taken into account. The 4 teeth with the deepest pockets will be included in the study and randomized to either PERIOSYAL® FILL and oral hygiene or oral hygiene alone.

Eligibility criteria: Inclusion Criteria:

* Men or women, aged between 25 and 60 years
* Patients with at least 20 natural teeth
* Patient with periodontitis confirmed by a X-ray diagnosis, and having at least 4 teeth with periodontal pockets with probing depth between 4 and 6 mm
* Willing to understand and comply with study requirements and to sign informed consent

Exclusion Criteria:

* Patient with an active smoking status
* Patient with an antibiotic therapy within the previous 4 weeks
* Need for continuous medical treatment within 2 weeks prior to enrollment
* Ongoing inflammatory state or a systemic illness that may affect the oral cavity
* Patient with hypofunction in saliva productions (e.g. Sjögren Syndrome with Xerostomia)
* History of active chronic debiliating systemic disease, including insulin or non-insulin dependent diabetes
* Patients with bleeding disorders
* History of allergies to gram positive bacterial proteins
* History of hypersensitivity and/or idiosyncrasies to any of the test compounds, e.g. hyaluronic acid or other device compounds
* History of multiple severe allergies, history of anaphylactic shock
* History of connective tissue disease (rheumatoid arthritis, scleroderma, systemic lupus erythematosus) or of any other autoimmunity disease
* History of herpetic lesion or lichen planus
* Pregnant or breast feeding women, or female subjects of childbearing potential who did not intend to practice medically acceptable method of contraception
* Participation in another clinical study in the previous 3 months

Primary outcomes:
measure: Change in Pocket Probing Depth (PPD)
timeFrame: Pre-injection, to 12, 24 and 48 weeks after baseline
Secondary outcomes:
measure: Change in Pocket Probing Depth (PPD)
timeFrame: Pre-injection, to 2, 5, 8 and 36 weeks after baseline
measure: Change in Clinical Attachment Level (CAL)
timeFrame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
measure: Bleeding On Probing (BOP)
timeFrame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
measure: Tooth Mobility
timeFrame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline
measure: Plaque Index (PI)
timeFrame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
measure: Gingival Index (GI)
timeFrame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
measure: Oral Health-related quality of life
timeFrame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline
measure: Microbiological analysis of the 11 main periodontal pathogens
timeFrame: : Pre-injection, to 12, 24, 36 and 48 weeks after baseline
measure: Physician satisfaction with the treatment
timeFrame: 12, 24, 36 and 48 weeks after baseline
measure: Subject Satisfaction with the treatment
timeFrame: 12, 24, 36 and 48 weeks after baseline
measure: Total volume of product injected in each of the included teeth
timeFrame: during each injection session
measure: Pain felt by the patient in the aera (tooth, gum)
timeFrame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Dental Specialist
city: Edewecht
country: Germany
facility: Dr. Wahlmann & Partner
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
References: