A Multi-Center Single Blind Study of the Laser Assisted New Attachment Procedure Compared to Scaling and Root Planing Alone, Modified Widman Flap Surgery, and Coronal Debridement Alone in the Treatment of Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Gain in Clinical Attachment Level of Periodontal Tissues
研究概览
简要总结
The purpose of this study is to compare the Laser Assisted New Attachment Procedure (LANAP protocol) using the Free-running (FR) Pulsed Neodimium: Yttrium aluminium garnet (Nd:YAG) laser to Scaling and Root Planing (SRP) alone, Modified Widman Flap (MFF) surgery, and Coronal Debridement (CD) alone with respect to periodontal clinical attachment level gain.
详细描述
This multi-center study of the Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser compared to Scaling and Root Planing alone, Modified Widman Flap (MWF) surgery, and Coronal Debridement (CD) alone will utilize a single-blind, four-quadrant split-mouth design with MWF as the positive control, CD as a weak positive control and SRP as the standard treatment control. The study will be conducted at three (3) to five (5) investigational centers. Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one quadrant of their mouth at Baseline. Treatment modalities are randomly assigned to quadrants at the time of treatment.
Efficacy evaluations, including clinical attachment level (CAL), probing depth (PD), and bleeding on probing (BOP) will be performed at Baseline, month 6, and month 12 using a Florida Electronic Probe. Radiographs will be taken at Screening/Baseline and at month 6 and month 12.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will have chronic adult periodontitis as characterized by all four quadrants of the mouth.
- •Subjects will be 25-75 years of age.
- •Subjects will be able to follow verbal and/or written instructions, perform Oral Hygiene according to the protocol, and return to the center for specified study visits.
- •Subjects must have had no subgingival scaling instrumentation including scaling and root planing, regular periodontal maintenance procedures or any subgingival cleaning < 12 (twelve) months prior to Baseline examination.
- •Subjects must have had no history of periodontal surgical procedures of any type prior to Baseline examination.
- •Subjects must be non-smokers of any type or former smokers (>6 (six) months stopped), and not using or taking any nicotine product.
- •Subjects will have clinical and/or radiographic evidence of subgingival calculus in each quadrant.
- •Subjects have no more than one missing tooth per quadrant, excluding 3rd molars.
- •Subjects will be able to sign the informed consent form.
排除标准
- •Subject receiving subgingival scaling instrumentation including scaling and root planing, regular periodontal maintenance procedures or any subgingival cleaning less than twelve (12) months prior to Baseline examination.
- •Subjects receiving periodontal surgery of any type prior to Baseline examination.
- •Subjects with dental implants.
- •Subjects with a compromised heart condition, history of rheumatic fever, or joint replacement requiring prophylaxis.
- •Subjects having taken systemic cancer therapy and/or radiation therapy at any time
- •Subjects with clinically significant acute or concurrent illness
- •Subjects with clinically significant chronic illness.
- •Subjects with a disease of the connective tissue.
- •Subjects taking medications which are likely to cause gingival hyperplasia, within ONE MONTH prior to Baseline examination
- •Subjects taking antimicrobials within ONE MONTH prior to Baseline examination
- •Subjects taking non-steroidal anti-inflammatory drugs at a therapeutic dose within the TWO WEEKS prior to Baseline examination.
- •Subjects taking steroids of any kind within ONE MONTH prior to baseline examination.
- •Subjects taking continuous low doses of tetracycline within THREE MONTHS prior to Baseline examination
- •Subjects taking an investigational drug within TWO MONTHS prior to Baseline examination
- •Subjects taking or having taken bisphosphonates of any kind for any reason.
- •Female, nonsterile subjects who are pregnant or lactating.
- •Subjects who, in the investigator's opinion, would not comply with the study procedures.
- •Smokers of any type or former smokers and subjects that take or use any nicotine product.
- •Excessive alcohol intake.
- •No current restorative or endodontic treatment needs
结局指标
主要结局
Gain in Clinical Attachment Level of Periodontal Tissues
时间窗: Baseline, 6, 12 months
Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.
次要结局
- Change in Probing Depth (PD)(Baseline, 6, 12 months)
- Change in Gingival Index(Baseline, 6, 12 months)
- Discomfort(1-7 days)
- Change in Bleeding on Probing (BOP)(Baseline, 6, 12 months)