跳至主要内容
临床试验/NCT06931678
NCT06931678已完成不适用

Evaluation of the Effectiveness of Root Canal Treatment Performed Using Photodynamic Therapy in Teeth With Apical Periodontitis in Patients With Type 2 Diabetes Through Next-Generation Sequencing Microbiome Analysis

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
1. Radiographic Assessment of Lesion Healing at 6 months

研究概览

简要总结

This clinical study investigates the effectiveness of antimicrobial photodynamic therapy (aPDT) as an additional disinfection method in root canal treatment of patients with Type 2 Diabetes Mellitus (T2DM) who have apical periodontitis (AP). T2DM is known to negatively impact the healing of periapical tissues due to impaired immune response. In this study, methylene blue is used as a photosensitizer, activated by a specific wavelength of light to eliminate residual bacteria that are difficult to reach with conventional cleaning methods. The bacterial load and changes in the root canal microbiome will be analyzed using next-generation sequencing (NGS) of the 16S rRNA gene. The goal is to assess the microbial elimination and healing of periapical lesions, and to improve treatment outcomes in diabetic patients.

详细描述

Systemic diseases such as Type 2 Diabetes Mellitus (T2DM) are known to influence both the etiology and healing process of endodontic diseases. T2DM is characterized by chronic hyperglycemia and impaired immune responses, which may negatively affect the resolution of periapical inflammation following root canal treatment. Apical periodontitis (AP) is a common endodontic pathology, often resulting from bacterial infection in the root canal system. The prevalence and severity of AP are higher in diabetic patients, and studies have shown reduced survival rates of endodontically treated teeth in this population.

The primary aim of this study is to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunctive disinfection method following conventional root canal preparation in T2DM patients with AP. aPDT utilizes a photosensitizer-methylene blue in this study-that, when activated by light of a specific wavelength, generates reactive oxygen species to eliminate residual microorganisms in complex anatomical areas such as isthmuses and lateral canals.

The study will utilize next-generation sequencing (NGS) of the 16S rRNA gene to assess bacterial diversity and quantify microbial elimination before and after aPDT application. The healing response of periapical lesions will also be monitored. The findings aim to contribute to improved treatment strategies and outcomes for endodontic therapy in systemically compromised patients, particularly those with T2DM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Individuals aged between 18 and 65 years
  • Voluntarily agree to participate in the study and attend follow-up sessions
  • Systemically healthy individuals (no systemic diseases)
  • Not taking antihypertensive or antidiabetic medications
  • Not pregnant
  • No use of corticosteroids or antibiotics within the last 3 months
  • No history of smoking
  • No acute pain or extraoral swelling
  • No sinus tract or acute apical abscess
  • Presence of a periapical lesion with a Periapical Index (PAI) score ≥ 3
  • Presence of a mature, single-rooted permanent tooth with completed root development

排除标准

  • • Severe periodontal disease
  • Internal or external root resorption
  • Open apex (immature root development)
  • Suspected vertical root fracture
  • Non-restorable teeth
  • Teeth with previous root canal treatment
  • Presence of developmental dental anomalies

结局指标

主要结局

1. Radiographic Assessment of Lesion Healing at 6 months

时间窗: Postoperative an avarage of 6 months

Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.

Change in Pain Level at day 1, day 3, and day 7 Post-Treatment

时间窗: Post-Treatment at day 1, day 3, and day 7

Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at day 1, day 3, and day 7 post-procedure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验