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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02391974
• Date of registration: 12/03/2015
• Prospective Registration: No
• Primary sponsor: Teoxane SA
• Public title: Efficacy and Safety of a Commercially Available Injectable Hyaluronic Acid Dental Filler for Periodontal Pockets
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02391974
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Periodontitis

Intervention(s)

Device: PERIOSYAL FILL

Primary Outcome(s)

Change in Pocket Probing Depth (PPD) [Time Frame: Pre-injection, to 12, 24 and 48 weeks after baseline]

Secondary Outcome(s)

Change in Clinical Attachment Level (CAL) [Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline]

Total volume of product injected in each of the included teeth [Time Frame: during each injection session]

Microbiological analysis of the 11 main periodontal pathogens [Time Frame: : Pre-injection, to 12, 24, 36 and 48 weeks after baseline]

Gingival Index (GI) [Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline]

Subject Satisfaction with the treatment [Time Frame: 12, 24, 36 and 48 weeks after baseline]

Oral Health-related quality of life [Time Frame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline]

Plaque Index (PI) [Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline]

Bleeding On Probing (BOP) [Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline]

Tooth Mobility [Time Frame: Pre-injection, to 12, 24, 36 and 48 weeks after baseline]

Change in Pocket Probing Depth (PPD) [Time Frame: Pre-injection, to 2, 5, 8 and 36 weeks after baseline]

Pain felt by the patient in the aera (tooth, gum) [Time Frame: Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline]

Physician satisfaction with the treatment [Time Frame: 12, 24, 36 and 48 weeks after baseline]

Secondary ID(s)

TEO-PER-1401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Syneed Medidata GmbH