Treatment of Peri-implantitis: Clinical Comparison Between Conventional Treatment Versus Conventional Plus Biolase Laser Treatment as a Co-adjuvant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Probing Depth (PD)
研究概览
简要总结
The purpose of the study is to observe the effects of two commonly utilized treatment modalities to treat peri-implantitis and to compare the results. The first method of treatment is debridement with curettes and ultrasonic scalers and it represents the traditional approach in the treatment of peri-implantitis. The second method of treatment involves the use of the Biolase laser in addition to the traditional approach of debriding with curettes and ultrasonic scalers. No studies exist comparing these two approaches, and this will serve as a pilot study to explore possible differences. The research hypothesis is that the addition of Er;Cr;YSGG laser is likely to be more effective in removing the microbiota from a rough implant surface, and that this will manifest with improved clinical parameters in subjects that receive this method of treatment.
详细描述
Peri-implantitis has been defined as an implant restoration with inflamed bleeding gingiva, probing depths around the implant of 5-8mm, bone loss and exposure of threads around the implant (limited to one-third of the threads exposed). The purpose of this study is to determine the benefits of treating peri-implantitis with a closed laser approach known as the "Repair Protocol" using an Er,Cr:YSGG laser compared with traditional non-surgical therapy. Each subject, when determined to fall under the parameters of the study for peri-implantitis, will be randomly assigned to one of two groups: the test Er,Cr:YSGG laser group or the control group.
The study will constitute a human double-blind randomized clinical trial in which both examiners and patients will be blinded to the treatment. In order to ensure the blinding of the patients, the laser will be applied to all implants, although the it will not be activated in the control group. The therapist will be the same person throughout the study while the examiners will be calibrated.
The two groups that will constitute the study and the procedures that will be applied are:
Experimental: Scaling and root planning with an ultrasonic or piezoelectric instrument and hand instrumentation with hand instruments. No prosthetic components will be removed . Application of laser therapy following the specifics of the company.
Control: Scaling and root planning with an ultrasonic or piezoelectric instrument and hand instrumentation with hand instruments. A sham, inactivated laser, treatment will be delivered.
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
- Triple (Participant, Investigator, 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
- •Presence of at least one implant presenting with early to moderate peri-implantitis
- •Peri-implantitis defined as an implant restoration with inflamed bleeding gingiva, probing depths around the implant of 5-8mm, bone loss and exposure of threads around the implant (limited to one-third of the threads exposed).
- •Medically healthy non-smokers with no previous periodontal treatment other than routine maintenance
- •Patients with diabetes were only included if they reported an HbA1C of 7% or less within the past 3 months
排除标准
- •Mobility of the implant
- •Peri-implantitis treatment rendered in the last 3 months
结局指标
主要结局
Change in Probing Depth (PD)
时间窗: Baseline, 9 months
Measured in mm with a manual periodontal probe (UNC-15). Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
次要结局
- Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)(Baseline, 9 months)
- Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque(Baseline, 9 months)
- Change in Radiographic Bone Loss Around the Implant(Baseline, 9 months)
- Presence of Suppuration on Probing(9 months)
- Mobility: Mean Change in the Clinical Attachment Level (CAL)(Baseline, 9 months)
研究者
Philip Y. Kang
Associate Professor of Dental Medicine
Columbia University