跳至主要内容
临床试验/NCT06719674
NCT06719674进行中(未招募)不适用

Impact of Diode Laser as an Adjunct to Professional Mechanical Plaque Removal (PMPR) in Patients With Periodontitis: A Randomized Clinical Trial

University of Sulaimani2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1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)
入组人数
40
试验地点
2
主要终点
Reduction in probing pocket depth (mm)

研究概览

简要总结

This study will utilize diode laser to determine its effects on improving periodontal parameters and inflammatory biomarkers, comparing with conventional treatment alone, and evaluate its effectiveness in improving periodontal disease's clinical parameters. Several studies have compared the effects of lasers and conventional periodontal treatment, comparing only its microbiological and clinical parameter levels and therapy to determine their effectiveness in key periodontal pathogens eradication and their effects on improving the clinical parameters of periodontal disease, in this study, salivary biomarkers will be collected and assessed to do a comparison between two treatment modalities. To the best of our knowledge, this is the first study to examine the effect of diode lasers on salivary biomarker levels.

详细描述

Periodontitis is an inflammatory disease caused by dental biofilm that provokes a chronic immune-inflammatory response that eventually causes the gradual loss of the periodontal tissues supporting the teeth. The evaluation of the disease is determined by clinical attachment loss (CAL), probing pocket depth (PPD), bleeding on probing (BOP), and the assessment of alveolar bone radiographically. Periodontal disease is a well-established disease that certainly impacts the general well-being of patients. It is closely linked to poor oral health-related quality of life, particularly in patients with moderate to severe periodontitis.

Moreover, a comprehensive study has demonstrated a direct correlation between the severity of the disease, as indicated by higher staging and grading, and an increased likelihood of tooth loss. The primary goal of periodontal therapy is to prevent or arrest the spread of the periodontal infection. The standard treatment approaches involve non-surgical or surgical periodontal therapy. Mechanical instrumentation (professional mechanical plaque removal - PMPR) is the gold standard in treating periodontal diseases; however, it can be challenging to reach and effectively remove calculus and bacterial deposits in the irregular and furcation areas. Therefore, an adjunctive aid like systemic or local antibiotics is sometimes necessary to be administered. Nevertheless, they have many adverse effects and it is also important to reduce the use of systemic antibiotics given the increases in antimicrobial resistance that occur globally.

Another adjunctive aid such as laser has been introduced to the field of periodontology to achieve bacterial eradication with minimum side effects. The term "laser" is derived from the abbreviation "light amplification by stimulated emission of radiation." A laser is a device that produces a well-aligned light beam that is well concentrated, which can maintain its narrowness across a significant distance and be firmly focused. When targeted towards tissues, many interactions occur. The behavior of laser light, including absorption, reflection, transmission, and scattering, is influenced by the laser's wavelength and the tissue's properties.

The primary objective of adjunctive laser use in periodontal therapy is to eliminate the inflamed and necrotic tissues located within the periodontal sulcus. The use of lasers is a contemporary adjunctive to traditional periodontal therapy for treating periodontitis. The alleged benefits of laser therapy include enhanced accessibility to root surfaces, more reliable control of bleeding, and better patient acceptability as it eliminates the requirement for conventional surgical flaps and sutures.

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 (Participant)

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

  • Patient with periodontitis.
  • Patients having at least 3 teeth with PPD of 5 mm and above.

排除标准

  • Patients with diabetes
  • Patients on medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatory drugs.
  • Patients received antibiotics within the last three months.
  • Pregnant or nursing women
  • Patients receiving periodontal therapy within the last 3 months

研究组 & 干预措施

Professional Mechanical Plaque Removal + Laser

Experimental

The patients will be treated in accordance with treatment guidelines for Stage III periodontitis issued by the European Federation of Periodontology. At baseline, oral hygiene instructions were given together with supra- and subgingival professional mechanical plaque removal (PMPR) using a combination of the ultrasonic scaler and hand instruments plus diode laser, according to the clinical situation. After completing treatment, patients will be asked to return at 1 month for review and again at 3 months to repeat the measurement of clinical parameters and collection of the saliva samples.

干预措施: Professional mechanical plaque removal and Laser (Procedure)

Professional Mechanical Plaque Removal

Active Comparator

The patients will be treated in accordance with treatment guidelines for Stage III periodontitis issued by the European Federation of Periodontology (13). At baseline, oral hygiene instructions were given together with supra- and subgingival professional mechanical plaque removal (PMPR) using a combination of the ultrasonic scaler and hand instruments, according to the clinical situation. After completing treatment, patients will be asked to return at 1 month for review and again at 3 months to repeat the measurement of clinical parameters and collection of the saliva samples.

干预措施: Professional mechanical plaque removal (Procedure)

结局指标

主要结局

Reduction in probing pocket depth (mm)

时间窗: 3 months

Probing pocket depth determined from the gingival margin to the base of the pocket at six sites per tooth.

次要结局

  • Biomarkers level in pg/ML: (interleukin (IL)-1beta), Matrix metalloproteinases (MMP 8) and (TIMP), RANK.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarhang Gul

Asst. Prof. Dr.

University of Sulaimani

研究点 (2)

Loading locations...

相似试验

Diode Laser as an Adjunct to Professional Mechanical... | 临床试验