Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets

Teoxane

Status and phase

Unknown

Phase 4

Conditions

Chronic Periodontitis

Treatments

Device: PERIOSYAL FILL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02391974

TEO-PER-1401

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

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