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临床试验/NCT05834517
NCT05834517已完成4 期

''Efficacy of Locally Delivered Hyaluronic Acid Gel as an Adjunctive to Non-Surgical Management of Stage II or Stage III Periodontitis

Ehab Haider Hassan El-emam1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
clinical score

研究概览

简要总结

Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013).

Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997).

There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).

详细描述

Periodontitis is a chronic multifactorial inflammatory disease, associated with the dental plaque biofilms, its distinct feature is destruction of the tooth supporting apparatus. Its main features include: damage of the periodontal tissue, that's manifested by clinical attachment loss, alveolar bone loss, periodontal pocketing and bleeding gum (Armitage, 1999).

A new periodontitis classification scheme has been approved, in which forms of the disease previously known as "chronic" or "aggressive" are now gathered under a single term ("periodontitis") and are more characterized based on a multi-dimensional staging and grading system. Staging is basically reliant on the severity of disease as well as on the difficulty of disease management, on the other hand , grading offers additional information about biological aspects of the disease including a history-based analysis of the rate of periodontitis progression; risk assessment for further progression and analysis of likely poor outcomes of treatment (Caton et al., 2018; Papapanou et al., 2018).

Host-Microbial interaction is having a huge effect on the nature of periodontal disease progression. The microbial biofilm elicits the host to release inflammatory mediators that have a negative effect on the connective tissues. The biofilm or dental plaque is required but not enough to induce periodontitis, since it is the host inflammatory response to this microbial challenge that eventually can be the reason for destruction of the periodontium (Haffajee and Socransky, 1994; Page , 1997; Darveau, 2010).

Physical removal of dental plaque through debridement and/or using antimicrobial agents is the most prevalent management of periodontitis. Initially, scaling and root planing (SRP) is done with the means of hand or ultrasonic instruments to debride the root surface, allowing the development of a long junctional epithelium. Clinically, in case of lack of accessibility like extensive tissue loss, deep periodontal pocket and furcation involvement make it unclear to determine the efficacy of the debridement (Lindhe, 1985).

The use systemic antibiotics (ABs) can contribute in treatment goals without surgical treatment. However, their usage is limited to particular patients for those who have previously two courses of SRP with no improvement in periodontal pocket depth. Additionally, the side effects and rise in AB resistance over time have reduced the number of cases managed in this way (Walters et al., 2015).

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)

盲法说明

The eligible participants will be randomly allocated for one of the two groups; test and control group using computer generated random tables.

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • .Patients have to be free from any systemic disease as proven by Burket's oral medicine health history questionnaire (Glik et al., 2008).
  • .Both genders aged 20-
  • . Periodontitis (Stage II or stage III) Patients; (3-6 mm CAL ,pocket depth ≤7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis) (Tonetti et al., 2017).

排除标准

  • Pregnant lactating females
  • Patients who can't be committed to oral hygiene instructions
  • History of periodontal surgery or antimicrobial therapy for at least 4 months.

研究组 & 干预措施

hyaluronic acid/ scaling

Experimental

topical application of hyaluronic acid after scaling by 1 day

干预措施: Hyaluronic acid (Drug)

hyaluronic acid/ scaling

Experimental

topical application of hyaluronic acid after scaling by 1 day

干预措施: non surgical periodontal therapy (Procedure)

scaling

Experimental

scaling only

干预措施: non surgical periodontal therapy (Procedure)

结局指标

主要结局

clinical score

时间窗: 3 months

1-Plaque index (PI) 2. Sulcus bleeding index (BI) 3-Probing depth (PD) 4-Clinical attachment loss level (CAL)

次要结局

  • analyzing quantitative changes of pathogenic periodontal bacteria as a secondary objectives.(1 month)

研究者

发起方
Ehab Haider Hassan El-emam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ehab Haider Hassan El-emam

ehab haider hassan elemam

Ain Shams University

研究点 (1)

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