跳至主要内容
临床试验/NCT07263763
NCT07263763已完成不适用

Clinical and Microbiological Characteristics of Orthodontic Patients With Fixed Appliances Treated for Gingival Hyperplasia Using Surgical Scalpel and Diode Laser: A Randomized Clinical Trial.

Nguyen Thu Thuy2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Gingival margin position

研究概览

简要总结

Gingival enlargement is a common complication in orthodontic patients, often resulting from plaque accumulation and chronic inflammatory response during fixed appliance therapy. Surgical gingivectomy is frequently required to restore gingival contour, improve esthetics, and facilitate oral hygiene. Traditionally, gingivectomy is performed using a scalpel, but laser-assisted techniques have recently gained popularity due to their potential benefits, including reduced bleeding, postoperative discomfort, and faster healing.

This randomized split-mouth clinical trial aims to compare the clinical and microbiological outcomes of gingivectomy performed with a diode laser versus conventional scalpel surgery in orthodontic patients presenting with gingival enlargement. Clinical parameters, microbial profiles, and patient-reported outcomes will be evaluated at baseline and at multiple postoperative intervals to assess the effectiveness and advantages of each technique.

详细描述

Gingival enlargement is a frequent periodontal manifestation in patients undergoing fixed orthodontic treatment, primarily resulting from increased plaque retention and subsequent chronic inflammation. This condition can compromise esthetics, interfere with effective oral hygiene, and lead to periodontal complications if left untreated. Gingivectomy is the treatment of choice for removing excess gingival tissue and reestablishing physiological gingival contours. Conventional scalpel gingivectomy has been widely used; however, the advent of laser technology, particularly diode lasers, has provided an alternative surgical approach with potential clinical advantages, including better hemostasis, reduced intraoperative discomfort, faster wound healing, and less postoperative pain.

This study is designed as a randomized split-mouth clinical trial to compare the clinical and microbiological outcomes of gingivectomy performed using a scalpel versus a diode laser in orthodontic patients with gingival enlargement. Eligible participants will be recruited from the Orthodontics Department of the Ho Chi Minh City National Hospital of Odonto-Stomatology. Each patient will undergo gingivectomy on two contralateral quadrants: one quadrant treated with conventional scalpel surgery (control side) and the other with diode laser surgery (test side). The allocation of quadrants will be randomized.

Clinical parameters including Plaque Index (PlI), Gingival Index (GI), Probing Pocket Depth (PPD), Gingival Margin Position (GMP), and Bleeding on Probing (BoP) will be recorded at baseline and at multiple postoperative intervals. Subgingival plaque samples will be collected for microbiological analysis using real-time polymerase chain reaction (qPCR) to evaluate the presence and levels of periodontopathogenic bacteria. Patient-reported outcomes such as postoperative pain will also be assessed using a visual analog scale (VAS).

All surgical procedures will be performed by the same calibrated operator to minimize variability. Standardized oral hygiene instructions will be provided to all participants throughout the study period. The collected data will be analyzed to determine differences in clinical healing, microbial changes, and patient comfort between the two treatment modalities. The findings are expected to provide evidence-based insights into the advantages and limitations of diode laser gingivectomy compared with the traditional scalpel technique in orthodontic patients.

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
Single (Outcomes Assessor)

盲法说明

Due to the nature of the interventions, masking of participants and operators was not feasible. Outcome assessors were blinded to the type of intervention performed at each site.

入排标准

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

入选标准

  • Participants aged 18 years or older who agree to take part in the study.
  • Individuals in good general health with no history of systemic diseases.
  • Patients undergoing fixed orthodontic treatment with metallic brackets for at least 6 months and presenting with gingival enlargement.
  • Patients with good oral hygiene (Plaque Index [PlI] < 1) and who comply with the instructions provided by the dentist during the treatment period.

排除标准

  • History of using medications associated with gingival enlargement, such as anticonvulsants, immunosuppressants, or calcium channel blockers (e.g., phenytoin, cyclosporine, nifedipine, verapamil, diltiazem, felodipine, nitredipine, etc.).
  • Pregnant or breastfeeding women, or individuals using hormonal therapy.
  • Patients who have undergone periodontal treatment within the last 6 months.
  • Use of antibiotics within 3 months prior to study enrollment.
  • Presence or history of systemic diseases.
  • Patients who refuse the use of laser in treatment.
  • Patients who are uncooperative, have poor oral hygiene (PlI > 1), discontinue participation during the study, or fail to follow instructions throughout the study period.

结局指标

主要结局

Gingival margin position

时间窗: 1 month and 3 months after gingivectomy

Reduction in Gingival Overgrowth Index

次要结局

  • Probing Pocket Depth (PPD) Reduction(1 month and 3 months after gingivectomy)
  • Reduction in Gingival Index (GI)(1 month and 3 months after gingivectomy)
  • Reduction in Plaque Index (PlI)(1 month and 3 months after gingivectomy)
  • Reduction in Bleeding on Probing (BoP)(1 month and 3 months after gingivectomy)
  • Microbiological changes in subgingival plaque(1 month and 3 months after gingivectomy)
  • Postoperative pain score(1 day, 3 days and 7 days after gingivectomy)
  • Post-surgical bleeding(1 day, 3 days and 7 days post-surgery)

研究者

发起方
Nguyen Thu Thuy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nguyen Thu Thuy

Associate Professor - PhD

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

Loading locations...

相似试验

Gingival Hyperplasia Treatment With Surgical Scalpel... | 临床试验