Chronic Periodontitis
Conditions
Keywords
Hyaluronic acid, Periodontal pockets, Periodontitis
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.
Interventions
DEVICEPERIOSYAL FILL
Injection 2 weeks after standard periodontal treatment procedure on all teeth that need to be treated. Touch-up treatment provided at 3 and 6 weeks.
Sponsors
Syneed Medidata GmbH
Teoxane SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pocket Probing Depth (PPD) | Pre-injection, to 12, 24 and 48 weeks after baseline | PPD is defined as the distance from the gingival margin to the base of the gingival crevice, i.e. the bottom of the clinical pocket. PPD will be measured at six sites per tooth (DV, V, MV, DL, L, ML), using a constant-force computerized periodontal probe with a 0.2 mm precision. Only the deepest will be taken into account |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline | CAL is defined as the distance from the Cemento-Enamel Junction (CEJ) to the base of the probable crevice/pocket (the bottom of the clinical pocket) |
| Bleeding On Probing (BOP) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline | BOP is defined as presence/absence of bleeding within 15 seconds following pocket probing |
| Tooth Mobility | Pre-injection, to 12, 24, 36 and 48 weeks after baseline | Tooth Mobility will be assessed on the scale defined by Muehlemann |
| Plaque Index (PI) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline | PI will be measured for each tooth using the four-point scale Silness and Löe Plaque Index |
| Gingival Index (GI) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline | GI will be measured for each tooth using the four-point scale Silness and Löe Gingival Index |
| Change in Pocket Probing Depth (PPD) | Pre-injection, to 2, 5, 8 and 36 weeks after baseline | — |
| Microbiological analysis of the 11 main periodontal pathogens | : Pre-injection, to 12, 24, 36 and 48 weeks after baseline | Periodontal pathogens will be measured using micro-IDent plus 1/11 Hain tests, a noninvasive saliva prelevement using paper points |
| Physician satisfaction with the treatment | 12, 24, 36 and 48 weeks after baseline | Satisfaction will be assessed on a 5-grade subjective symmetrical scale |
| Subject Satisfaction with the treatment | 12, 24, 36 and 48 weeks after baseline | Satisfaction will be assessed on a 5-grade subjective symmetrical scale |
| Total volume of product injected in each of the included teeth | during each injection session | Volume will be measured to an accuracy of 0.025 mL |
| Pain felt by the patient in the aera (tooth, gum) | Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline | Pain will be self-assessed by the subject on each included teeth using a 100 mm Visual Analog Scale (VAS) |
| Oral Health-related quality of life | Pre-injection, to 12, 24, 36 and 48 weeks after baseline | Oral Health-related quality of life is a patient reported outcome measure specifically pertaining to oral health capturing both the functional, social and psychological impacts of oral disease, assessed using the OHQoL-GE, a validated translation of the OHQoL-UK |
Countries
Germany
Outcome results
None listed