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临床试验/CTRI/2024/07/070900
CTRI/2024/07/070900尚未招募4 期

Role Of Antimicrobial Photodynamic Therapy During Non Surgical Root Canal Treatment Of Teeth Having Apical Periodontitis In Individuals With Type 2 Diabetes Mellitus – A Clinical And Radiographic Evaluation.

Not applicable1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年8月22日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
42
试验地点
1
主要终点
change in apical bone density (PAI score) at 3, 6 months time interval and the presence of clinical signs & symptoms or abnormal findings (ie, spontaneous pain, presence of sinus tract, swelling, mobility, periodontal probing depth greater than baseline measurements, or sensitivity to percussion and palpation).

研究概览

简要总结

INTRODUCTION:

The success of endodontic treatment depends on the eradication of microbes from the root canal system. It is well established that the complete elimination of bacteria from root canals is extremely difficult, because of the intricate canal anatomy (1). Even thorough preparation of the root canal leaves part of the canal walls untouched, regardless of the instrumentation technique used (2), resulting in inconsistent removal of the contaminated

innermost layer of dentin (3,4). Accepted treatment procedures for root canal disinfection include mechanical debridement and shaping, irrigation with disinfecting agents such as sodium hypochlorite (NaOCl) and chlorhexidine, application of an interappointment antibacterial dressing, and sealing of the root canal (5,6). Novel approaches for disinfecting root canals include the use of high-power lasers (7) as well as photodynamic therapy (PDT) (8,9). High-power lasers function by dose-dependent heat generation. However, they have the potential to cause damage such as dentin charring, ankylosis, cementum melting, root resorption, and periradicular necrosis if

incorrect laser parameters are used (10). PDT is a new antimicrobial strategy that involves the use of a nontoxic photosensitizer (PS) and a light source (11). The evidence available from the existing literature regarding the relationship among Diabetes Mellitus, Apical periodontitis, and endodontic outcome is unclear.

On searching the literature, we found a few studies discussing the relationship between diabetes and Apical periodontits (13–17). Most of the studies are cross-sectional studies with a low level of evidence and have mainly investigated the prevalence of Apical Periodontitis in diabetic patients and not the endodontic success. Suman Arya et al. (2017) concluded that diabetes mellitus may have a negative impact on the outcome of endodontic

treatment in terms of periapical healing (20). Thus, the present study was designed in a prospective manner, with the objective to investigate the success rate of primary nonsurgical root canal treatment with adjuvant

photodynamic therapy in type 2 diabetic patients and possible association of periapical healing with HbA1c level.

AIMS AND OBJECTIVES

  1. Clinical and radiographic evaluation of primary nonsurgical root canal treatment with

photodynamic therapy in type 2 diabetic patients with] apical periodontitis.

  1. To investigate the possible association of periapical healing with HbA1c levels.

MATERIALS AND METHODS:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow.

The study will be conducted only after getting clearance from Institutional Ethical Committee and registration in CTRI.

Study Population: Patients diagnosed with type 2 diabetes mellitus and apical periodontitis who provide written consent will be eligible for the study.

Randomization: Eligible patients will be randomly assigned to one of two test groups.

Treatment Groups:

Group I: Patients in this group will undergo biomechanical preparation followed by obturation.

Group II: Patients in this group will undergo biomechanical preparation followed by photodynamic therapy and then obturation.

Biomechanical Preparation: Both groups will receive biomechanical preparation, which involves cleaning and shaping the root canal system to remove infected or necrotic tissue.

Photodynamic Therapy (Group II): Patients in Group II will receive photodynamic therapy after biomechanical preparation but before obturation. This involves the use of light-sensitive compounds and light to target and destroy bacteria in the root canal system.

Obturation: After either biomechanical preparation (Group I) or photodynamic therapy (Group II), the root canal will be filled and sealed with a suitable material (obturation).

Evaluation:

Clinical Evaluation: Both groups will undergo clinical evaluation at specified time intervals to assess symptoms, such as pain or swelling, and overall oral health.

Radiographic Evaluation: X-rays will be taken at appropriate intervals to assess the healing of the apical periodontitis and the quality of the obturation.

Statistical Analysis: The data collected from clinical and radiographic evaluations will be subjected to statistical analysis to compare the outcomes between the two groups.

Adaptations: If any changes are deemed necessary during the study, they will be made in the best interest of the study’s integrity, possibly based on interim analyses or emerging literature.

This protocol outlines a rigorous scientific approach to evaluating the effectiveness of photodynamic therapy in conjunction with traditional root canal treatment in patients with type 2 diabetes mellitus and apical periodontitis.

INCLUSION CRITERIA

  1. Patients with a history of type 2 DM (with HbA1c ≥6.5%)

  2. Patients age within 30-55 years

  3. Mature permanent teeth with apical periodontitis as confirmed by a negative

response to cold and electric pulp tests

  1. Radiographic evidence of AP (minimum size 2 mm ×2 mm)

EXCLUSION CRITERIA

  1. Patients with Periodontitis with pocket depth ≥ 4mm

  2. Systemic disorders other than diabetes mellitus (type 2)

  3. Patients taking steroids, pregnant patients

  4. Patients with cracks/fractures of the tooth

  5. Patients who underwent a procedural errors

  6. Smokers

  7. Patients with a history of antibiotic intake in the preceding month were excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients with a history of type 2 DM (with HbA1c ≥6.5%)
  • Mature permanent teeth with apical periodontitis as confirmed by a negative response to cold and electric pulp tests
  • Radiographic evidence of AP (minimum size 2 mm ×2 mm).

排除标准

  • Patients with Periodontitis with pocket depth ≥ 4mm
  • Systemic disorders other than diabetes mellitus (type 2)
  • Patients taking steroids, pregnant patients
  • Patients with a history of antibiotic intake in the preceding month were excluded from the study.

结局指标

主要结局

change in apical bone density (PAI score) at 3, 6 months time interval and the presence of clinical signs & symptoms or abnormal findings (ie, spontaneous pain, presence of sinus tract, swelling, mobility, periodontal probing depth greater than baseline measurements, or sensitivity to percussion and palpation).

时间窗: Baseline, 3 & 6 months

次要结局

  • Comparison of the periapical healing with glycemic level of the patient(Baseline, 6 months)

研究者

申办方类型
Other [Not applicable]
责任方
Principal Investigator
主要研究者

Dr Abinia vaishnavi N

Faculty of Dental Sciences, King Georges Medical university, Lucknow

研究点 (1)

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