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
试验速览
- 阶段
- 4 期
- 发起方
- Teoxane SA
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in Pocket Probing Depth (PPD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Pocket Probing Depth (PPD)
时间窗: 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
次要结局
- Subject Satisfaction with the treatment(12, 24, 36 and 48 weeks after baseline)
- Change in Pocket Probing Depth (PPD)(Pre-injection, to 2, 5, 8 and 36 weeks after baseline)
- Change in Clinical Attachment Level (CAL)(Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline)
- Bleeding On Probing (BOP)(Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline)
- Plaque Index (PI)(Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline)
- Gingival Index (GI)(Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline)
- Microbiological analysis of the 11 main periodontal pathogens(: Pre-injection, to 12, 24, 36 and 48 weeks after baseline)
- Physician satisfaction with the treatment(12, 24, 36 and 48 weeks after baseline)
- Total volume of product injected in each of the included teeth(during each injection session)
- Oral Health-related quality of life(Pre-injection, to 12, 24, 36 and 48 weeks after baseline)
- Pain felt by the patient in the aera (tooth, gum)(Pre-injection, to 2, 5, 8, 12, 24, 36 and 48 weeks after baseline)
- Tooth Mobility(Pre-injection, to 12, 24, 36 and 48 weeks after baseline)