Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Early wound healing molecular events through GCF
研究概览
简要总结
The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.
详细描述
This is a parallel-group, pilot study aiming that consists of 7 visits over a minimum period of 4 months. Up to 24 periodontitis patients presenting with supra-bony defects will be recruited at the Centre for Oral Clinical Research (COCR) at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom.
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
- •Systemically healthy males and females ≥18 years old
- •Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)
- •Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) > 5 mm, following non-surgical periodontal therapy (NSPT). If >4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.
- •If defect presents with an intrabony component, this should be ≤2 mm.
- •Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months
- •Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%
排除标准
- •Teeth with degree III mobility
- •Multi-rooted teeth with grade ≥2 furcation involvement
- •Heavy smokers (≥10 cigarettes a day)
- •Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery
- •Previous periodontal surgery in the area selected for the study
- •History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)
- •Antibiotic or anticoagulant therapy during the month preceding the baseline exam.
- •History of alcohol or drug abuse
- •Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition
- •In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)
- •Self-reported pregnancy or lactation.
研究组 & 干预措施
Control
Periodontal Access Flap (AF)
干预措施: Periodontal Access Flap (AF) (Procedure)
Test
Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA)
干预措施: Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA) (Combination Product)
结局指标
主要结局
Early wound healing molecular events through GCF
时间窗: Baseline, 1, 4, 7, 15 days and 3 months after surgery from the deepest site of one tooth involved in the surgery
Characterize the early wound healing molecular events through gingival crevicular fluid (GCF) biomarkers. In particular, the expression of specific biomarkers involved in the recruitment of osteoblast precursors, inflammatory-immune response, organization of extracellular matrix, cell adhesion, oxidative stress and angiogenesis. Multiplex immunoassays will be employed to simultaneously assess the expression of multiple proteins in GCF samples on the biological processes involved in early periodontal wound healing and the mechanism of action of PNHA, focusing on the expression of specific signalling pathways, including but not limited to TNF alpha, NF-kappa B, IL-17, TGF-beta, VEGF, HIF-1, Chemokine and Wnt signalling pathways.
Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA
时间窗: Before and straight after completing the surgery, as well as at day 1, 4, 7, 15 and at 3 months
Blood flow changes in the surgical area will be evaluated with Laser Speckle Contrast Imaging (LSCI)
次要结局
- Clinical attachment level (CAL)(Baseline and 3 months post-surgery)
- Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery(Baseline and 3 months post-surgery)
- Suppuration(Baseline and 3 months post-surgery)
- Gingival phenotype(Baseline and 3 months post-surgery)
- Keratinized tissue (KT)(Baseline and 3 months post-surgery)
- Probing pocket depth (PPD)(Baseline and 3 months post-surgery)
- Full mouth plaque score (FMPS)(Baseline and 3 months post-surgery)
- Gingival recession (REC)(Baseline and 3 months post-surgery)
- Gingival morphometric changes(Baseline visit, at 1, 4, 7, 15 days and 3 months post surgery)
- Full mouth bleeding score (FMBS)(Baseline and 3 months post-surgery)
- Early Healing Index (EHI)(Day 1, 4, 7 and 15 after the surgical intervention)
- Oral impact on daily performance (OIDP)(Baseline and at 3 months post surgery)
- Global ratings of Periodontal Health and Quality of Life(3 months after surgery)
- Dentine/root sensitivity(Baseline and at 3 months post-surgery)
- Food impaction(Baseline and at 3 months post-surgery)
- Patient perception about therapy(At day 1, 4, 7 and 15 after surgical therapy)