Evaluation of Clinical and Biochemical Effects of Hyaluronic Acid on Periodontitis: A Split-mouth Randomized-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- gingival index (GI)
研究概览
简要总结
Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival crevicular fluid (GCF) in patients with periodontitis.
详细描述
Design: A total of 24 Stage II-III periodontitis patients will be included in this split-mouth, randomized-controlled study. The study population will be divided into four groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3 (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by spectrophotometric analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy
- •moderate-to-severe periodontitis
- •at least five sites with ≥5mm probing depth (PD)
- •at least ≥20 teeth
- •Stage II-III periodontitis according to the 2017 World Workshop
- •Age between18-55
排除标准
- •receiving systemic or local antibiotics within the past six months
- •prior surgical or non-surgical periodontal treatment within the past six months
- •pregnancy
- •lactation
- •age ≤18 years or ≥55 years
- •hypertension
- •known chronic systemic diseases (i.e., diabetes mellitus, rheumatoid arthritis), - - known hypersensitivity to one of the ingredients of the HA preparation.
研究组 & 干预措施
Scaling and root planning (SRP)
Under local anesthesia, full-mouth SRP was performed within 24 h in a single or two sessions using ultrasonic and hand instruments (Gracey, Hu-Friedy, Chicago, IL, USA) by a single investigator (DA). Immediately after the SRP, HA gel (Gengigel, Hyaluronic acid, gingival gel, Ricefarma S.R.L, Italy) or mouthrinse was performed according to the groups' procedure. In Group 1, the periodontal sulcus was irrigated with saline solution after SRP.
干预措施: Scaling and root planning (Procedure)
Hyaluronic acid gel (HA) and SRP
Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular.
干预措施: Scaling and root planning (Procedure)
Hyaluronic acid gel (HA) and SRP
Group 2, after SRP was performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA was applied intrasulcular.
干预措施: Hyaluronic acid gel (HA) and SRP (Drug)
HA mouthrinse and SRP
In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.
干预措施: Scaling and root planning (Procedure)
HA mouthrinse and SRP
In Group 3, HA hydrogel mouthrinse (Gengigel, Hyaluronic acid, Hydrogel moutrinse for gums, Ricefarma S.R.L, Italy) were used as an irrigator after SRP.
干预措施: HA mouthrinse and SRP (Drug)
HA mouthrinse+gel and SRP
In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.
干预措施: Scaling and root planning (Procedure)
HA mouthrinse+gel and SRP
In Group 4, after SRP was performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel was applied.
干预措施: HA mouthrinse+gel and SRP (Drug)
结局指标
主要结局
gingival index (GI)
时间窗: Change from Baseline to week 4
confirming to Silness and Löe index (Löe \& Silness, 1963)
gingival recession height (GRH)
时间窗: Change from Baseline to week 4
as the measurement of the distance between the marginal gingiva and cemento-enamel junction
plaque index
时间窗: Change from Baseline to week 4
in accordance with the Sillness and Löe index (Silness \& Löe, 1964)
bleeding on probing (BOP)
时间窗: Change from Baseline to week 4
according to Ainoma and Bay (AINAMO \& Bay, 1975);
Probing depth (PD)
时间窗: Change from Baseline to week 4
as the measurement of the length between the bottom of the periodontal pocket to marginal gingiva;
clinical attachment level (CAL)
时间窗: Change from Baseline to week 4
as the sum of gingival recession height and probing depth will be recorded.
次要结局
- Changes of Periodontal inflammed surface area(Change from Baseline Baseline to week 4)
- Changes of Glutathione levels in gingival crevicular fluid(Changes from Baseline to week 1,2,4)
- Changes of Adenosine deaminase (ADA) levels in gingival crevicular fluid(Changes from Baseline to week 1,2,4)
- Changes of Catalase levels in gingival crevicular fluid(Changes from Baseline to week 1,2,4)
研究者
Hacer Sahin Aydinyurt
Assist Prof
Yuzuncu Yıl University