The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Full mouth plaque score (FMPS).
研究概览
简要总结
Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.
Several studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. The use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues.
The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).
Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.
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 (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
- 是
入选标准
- •Aged 18 or over.
- •Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.
- •Good compliance and commitment to attend follow-up review appointments.
- •Willing to provide informed consent.
排除标准
- •Received periodontal treatment in the last 12 months.
- •Received systemic antibiotic in the last 6 months.
- •Pregnancy or lactating participants
结局指标
主要结局
Full mouth plaque score (FMPS).
时间窗: Change from baseline FMPS at six months
The plaque score is calculated by expressing as a percentage the number of surfaces harbouring plaque related to the total number of tooth surfaces.
Full mouth bleeding score (FMBS).
时间窗: Change from baseline FMBS at six months
The bleeding score is calculated by expressing as a percentage the number of sites that bleed upon probing in relation to the total number of tooth sites.
Clinical attachment level (CAL).
时间窗: Change from baseline CALs at six months
CAL is calculated from a fixed reference point (cementoenamel junction or CEJ), and it is computed by calculating the distance from the CEJ to the base of the pocket in millimeters.
Number of sites PPDs ≥ 6 mm.
时间窗: Change from baseline number of sites with PPDs ≥ 6 mm at six months
Number of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
Percentages of sites PPDs ≥ 6 mm.
时间窗: Change from baseline percentages of sites with PPDs ≥ 6 mm at six months
Percentages of sites with PPDs ≥ 6 mm. PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
Probing pocket depth (PPD).
时间窗: Change from baseline PPDs at six months
PPD is the depth from the free gingival margin to the base of the sulcus and it is measured in millimeters at several locations around the whole circumference of the tooth.
次要结局
- Postoperative bruising(Change from baseline bruising at seven days)
- Postoperative pain(Change from baseline pain at seven days)
- Postoperative bleeding(Change from baseline bleeding at seven days)
- Postoperative root sensitivity(Change from baseline root sensitivity at seven days)
- Quality of life measures(Change from baseline GOHAI score at six months days)
- Operating time(Outcome measures will be recorded at baseline)
- Postoperative swelling(Change from baseline swelling at seven days)
研究者
Associate Professor Momen Atieh
Chair and Associate Professor (Periodontology)
Mohammed Bin Rashid University of Medicine and Health Sciences