跳至主要内容
临床试验/NCT06740123
NCT06740123进行中(未招募)不适用

Clinical, Radiological, and Biochemical Evaluation of Adjunctive Hydrogel Application in the Non-Surgical Treatment of Peri-implantitis and Periodontitis

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Periodontal or peri-implant pocket depth

研究概览

简要总结

To date, systemic/local antibiotics, antimicrobials, laser application, and probiotics have been used as adjuncts to improve the outcome of non-surgical periodontal treatment for both periodontitis and peri-implantitis patients. H42® hydrogel, obtained by combining a high molecular weight hydrogel with type I collagen, is a collagen paste for regenerating periodontal/peri-implant pockets caused by periodontitis/peri-implantitis. This study aimed to clinically, biochemically, and radiologically evaluate the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontal and peri-implant pockets.

Fifteen patients with stage 2 periodontitis, each with 30 teeth and 30 implants with 5-8 mm pocket depth in the contralateral quadrants, and a total of 30 patients, will be equally divided into two groups. The test group will receive non-surgical periodontal treatment followed by H42 hydrogel application (Hydrogel Oral- 3 syr 0.4 cc/syr), while the control group will receive only non-surgical periodontal treatment. All patients will undergo the same procedure of non-surgical periodontal treatment

详细描述

Periodontitis is a chronic, multifactorial, inflammatory disease associated with biofilm and characterized by the destruction of the bone supporting the tooth. Peri-implantitis is an inflammatory disease associated with inflammation of the peri-implant mucosa followed by progressive bone destruction of varying degrees, with a peri-implant pocket depth of at least 4 mm, accompanied by symptoms such as bleeding and suppuration. Peri-implantitis and periodontitis have similar microbial flora, but peri-implantitis is more complex. In periodontitis and peri-implantitis patients, adjunctive therapies are needed to support non-surgical treatment and to strengthen the immune system by suppressing periodontal pathogens. Adjunctive therapies include local and systemic antibiotics, laser applications, antimicrobials, probiotics, photodynamic therapy, host-modulating agents, enamel matrix protein, injectable platelet-rich fibrin, hyaluronic acid gel, and other medications. H42® hydrogel, obtained by combining a high molecular weight hydrogel with type I collagen; It is an applied collagen paste that helps non-surgical periodontal treatment of periodontal and peri-implant diseases with its physical, bio-chemical, and rheological properties. The plugging effect and visco-elasticity of the hydrogel limits bacterial recolonisation after the use of mechanical instruments in periodontal/peri-implant pockets and allow the regeneration of periodontal/peri-implant pockets caused by periodontitis/peri-implantitis. When the H42® hydrogel is applied to the affected area, it physically moves away from the implant site over a period of 15-30 days and does not need to be removed from the application site.

To evaluate clinically, biochemically and radiologically the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontitis/peri-implantitis patients with periodontal/peri-implant pockets between 5-8 mm contralaterally.

A total of 30 patients, including 15 systemically healthy patients older than 18 years of age, with Stage 2 periodontitis and periodontal/peri-implant pockets between 5-8 mm on the contralateral side, who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology, will be included in the study.

Study group periodontal pockets: Thirty teeth in 15 patients with stage 2 periodontitis with 5-8 mm pocket depth in the contralateral quadrants will be equally divided into two groups.

Group I (Test Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment and intrapocket H42 hydrogel application.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, 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

  • •be over 18 years old
  • •The patient does not have any systemic disease
  • •Patients with a probed pocket depth of 5-8 mm in at least one tooth in the opposite quadrant
  • •According to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions, patients of both sexes, aged 25-50 years, diagnosed with stage 2, grade B periodontitis
  • •Patients with clinical loss of attachment of 3-4 mm, bleeding during probing and radiographic horizontal bone loss in the coronal third of the root (15-33%)
  • •Clinical attachment loss of 3-4 mm in <30% of teeth associated with periodontitis
  • •Patients with a radiographic bone loss/age of 0.25-1 on the tooth with the greatest bone loss in the degree of periodontitis
  • •Patients without anti-inflammatory drug use in the last 2 months
  • •Patients who have not received antibiotic treatment in the last 6 months

排除标准

  • •Any systemic disease that may adversely affect the results of treatment (receiving radiotherapy and chemotherapy, systemic bisphosphonate, and corticosteroid use) to be found
  • •To have undergone a surgical operation in the same region within the last 3 months
  • •Smoking patients
  • •Presence of systemic conditions requiring antibiotic prophylaxis
  • •Acute and untreated periodontitis
  • •Patients receiving simultaneous treatment with a hyaluronic acid gel

研究组 & 干预措施

Periodontal pocket (Test group)

Experimental

To be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.

干预措施: Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket (Procedure)

Periodontal pocket (Control group)

Experimental

To be treated with non-surgical periodontal treatment only

干预措施: Nonsurgical periodontal treatment of periodontal pocket (Procedure)

Peri-implant pocket (Test group)

Experimental

Will be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.

干预措施: Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket (Procedure)

Peri-implant pocket (Control group)

Experimental

will be treated with non-surgical periodontal treatment only

干预措施: Nonsurgical periodontal treatment of peri-implant pocket (Procedure)

结局指标

主要结局

Periodontal or peri-implant pocket depth

时间窗: 3-month follow-up of all implants and teeth

The primary outcome was the distance between the base of the periodontal sulcus and the gingival margin measured with a standard periodontal probe at 3-month follow-up.

Proinflammatory markers

时间窗: 3-month follow-up of all implants and teeth

Gingival crevicular fluid samples are analyzed for proinflammatory markers IL-6, Prostaglandin E2 and IL-1 beta and TNF-alpha using the ELISA method at 3-months follow-up.

Marginal bone level change

时间窗: 6-month follow-up of all implants and teeth

The primary outcome was measurement of marginal bone level on periapical radiographs and cone-beam computed tomography at 6-month follow-up.

次要结局

  • Patients participating in the evaluation of a treatment may encounter both adverse and beneficial events associated with that treatment(6-month follow-up of all implants and teeth)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berceste Guler

Associate Professor Dr.

Kutahya Health Sciences University

研究点 (1)

Loading locations...

相似试验