Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes in the expression of GCF wound healing biomarkers
研究概览
简要总结
This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.
The study will consist of 7- 8 visits.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 and above
- •Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.
- •Periodontitis stage III/IV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm
- •Willing to sign informed consent and comply with study procedures
排除标准
- •Know hypersensitivity and/or allergy to any of the product's component (as per user leaflet)
- •Self-reported pregnancy or lactation
- •Smoking (current or in past 5 years), including e-cigarettes/vaping
- •Medical history including diabetes mellitus or other serious medical/ psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation
- •History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or/and systemic antibiotic therapy during the 3 months preceding the baseline evaluation
- •In chronic treatment with anti-inflammatory (including corticosteroids), anticoagulants/antiplatelets (including aspirin), immunosuppressants or other medication that can severely impact wound healing
- •History of alcohol or drug abuse
- •Subgingival professional mechanical plaque removal (excluding not-extensive subgingival debridement as judged by the examining clinician) and/or surgical periodontal treatment within the last 12 months
- •Other severe acute or chronic medical or psychiatric condition or psychological disorder, including limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed, or any additional conditions which, in the judgement of the investigator, would make the subject inappropriate for entry into this trial
研究组 & 干预措施
Test Group
Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.
干预措施: Hyaluronic Acid (HA) and Octenidine gel (Combination Product)
Test Group
Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel.
干预措施: Non-surgical periodontal treatment (NSPT) (Procedure)
Control Group
Non-surgical periodontal treatment (NSPT) alone.
干预措施: Non-surgical periodontal treatment (NSPT) (Procedure)
结局指标
主要结局
Changes in the expression of GCF wound healing biomarkers
时间窗: Baseline, 1, 7, 15, 30 days and 3 months following treatment
Changes in the expression of GCF wound healing biomarkers at 1, 7, 15, 30 days and 3 months following treatment will be assessed. A subset of analytes involved in the healing process and signalling pathways such as i) inflammation/immune response (e.g., IL-1 β, IL-1 α, IL-6, IL-8, IL-4, IL-10,IL-17, TNF- α, MMP-1, MMP-8, MMP-9, TIMP-1), ii) bone formation/resorption (e.g., TGF- β, osteocalcin, osteopontin, osteoprotegerin, BMP-2), iii) oxidative stress (e.g., Myeloperoxidase), and iv) angiogenesis (e.g., VEGF, angiopoietin-1) will be selected based on the pathways identified and optimized in the genomic and proteomic work from our group. Multiplex immunoassays will be designed specifically for quantitative analyses in the GCF for the 2 groups at the different time points.
次要结局
- Changes in the Blood flow(Baseline and at 1, 7, 15, and 30 days following treatment.)
- Changes in the suppuration(Baseline and at 3 months after intervention)
- Patient perception about therapy(1,7 and 15 days after procedure)
- Changes in the bacterial load(Baseline and at 7, 15, 30 days and 3 months following treatment.)
- Changes in the clinical attachment level (CAL)(Baseline and at 3 months after intervention)
- Changes in the Full mouth bleeding score (FMBS)(Baseline and at 3 months after intervention)
- Global changes in quality of life(3 months after procedure)
- Changes in the gingival recession (REC)(Baseline and at 3 months after intervention)
- Soft tissues contour changes(Baseline, 1, 7, 15, 30 days, and 3 months following treatment)
- Dentin hypersensitivity(Baseline, 1, 7, 15, 30 days, and 3 months after procedure)
- Changes in the probing pocket depth (PPD)(Baseline and at 3 months after intervention)
- Changes in the Full mouth plaque score (FMPS)(Baseline and at 3 months after intervention)
- Changes in the periodontal inflamed surface area (PISA)(Baseline and at 3 months after intervention)