Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Clinical Attachment Level (CAL)
研究概览
简要总结
The purpose of this research project is to gain information on the best and most comfortable way to treat the periodontal disease. The main objective is to compare the efficacy of conventional scaling and root planning compared to laser scaling for the non-surgical treatment of periodontal disease. Both therapies have shown to be effective and are regularly used in the dental clinic.
详细描述
The study has been designed as a single blinded split-mouth randomized controlled clinical trial. Patients will be randomized prior to treatment, to which the examiner will be blinded. Clinical parameters will be recorded at baseline and 3 months after treatment has been completed. At the time of recruitment, inclusion/exclusion criteria checklist, informed consent and baseline measurements will be obtained and recorded. Medical history will be updated and radiographs will be reviewed or taken. During the second appointment, conventional scaling and root planing will be performed in the corresponding quadrant; during the third appointment, laser therapy will be conducted, 1 month after, during the forth appointment, a follow up (no measurements) will be scheduled with provider, and 3 months after scaling completion, measurements will be taken and periodontal maintenance performed. Patient will receive home care instructions at every visit and will fill out a visual analogue scale at baseline, 1 month and 3 month visit.
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)
盲法说明
Examiner was blinded to treatment allocation during baseline and at the 3 month re-evaluation
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
- •Signed and dated Informed Consent
- •Good general health
- •Participants > 18 years of age
- •Participants with > 20 teeth with 5 teeth, including at least 1 molar, in each quadrant of the mouth
- •Participants with > 30% of the present teeth with Probing depths of > 4mm and Bleeding on Probing
- •Non-smoker and former smokers (stopped smoking > 1 year)
- •Participants that have not received any periodontal treatment in the past 3 months
排除标准
- •Participants with uncontrolled systemic diseases that could affect the treatment outcome such as Diabetes with HbA1c > 7.0 percent, rheumatoid arthritis, immunosuppression, HIV with detectable viral loads
- •Participants requiring antibiotic prophylaxis for any cardiovascular conditions or after any transplant and/or replacement procedures
- •Pregnant women
- •Patients treated with systemic antibiotic therapy of periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration
- •Patients being chronically (two weeks or more) treated with any NSAIDs, steroids or any medications known to affect soft tissue condition (excluding treatment with Acetylsalicylic acid < 100 mg/day)
- •Presence of orthodontic appliances, or any removable appliances that impinges on the tissues being assessed.
- •Presence of soft or hard tissue tumors of the oral cavity
- •The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study
研究组 & 干预措施
Scaling and Root Planing with Hand Instruments
Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)
干预措施: Scaling and root planing (Procedure)
Scaling and Root Planing with Hand Instruments
Patients will undergo scaling and root planing with hand instruments (half of their mouth, following a split-mouth design)
干预措施: Hand instruments (Device)
Er:YAG Laser Scaling
Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.
干预措施: Scaling and root planing (Procedure)
Er:YAG Laser Scaling
Patients will undergo scaling and root planing with Er:YAG Laser in the untreated half of their mouth.
干预措施: Er:YAG Laser (Device)
结局指标
主要结局
Change in Clinical Attachment Level (CAL)
时间窗: 3 months after treatment
Calculated based on distance from CEJ to gingival margin and the pocket depth (site specific measurement)
Change in Pocket Depth (PD)
时间窗: 3 months after treatment
Measured at 6 sites per tooth in millimeters (mm) (site specific measurement). The mean value of the measurements was obtained for both treatment groups by averaging all teeth for each quadrant.
次要结局
- Plaque Index (PI)(3 months after treatment)
- Bleeding on Probing (BoP)(3 months after treatment)
- Average Duration of Treatment(Time between the start of treatment to treatment completion, up to 180 minutes)
- Number of Participants Who Preferred Modality(3 months after treatment)
- Number of Patients Who Experienced a Better Improvement in Sensitivity(Baseline and 3 months)
研究者
Philip Y. Kang
Assistant Professor of Dental Medicine (Periodontist) at the Columbia University Medical Center, College of Dental Medicine
Columbia University