A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Noninvasive Intraoral Electrotherapy Device for the Treatment of Patients With Periodontitis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Reductions in the probing depth
研究概览
简要总结
A parallel-armed, sham-controlled, and participant-blind pilot study will be conducted to determine the safety and effectiveness of use of a noninvasive intraoral electrotherapy device to treat periodontal disease. A total of 30 patients were randomly assigned to one of two groups. The trial was comprised of three in-office oral examinations, which were performed at baseline, and at follow-ups～6 weeks (42 days ± 3 days) and～3months (84 days ± 3 days later).
详细描述
A parallel-armed, sham-controlled, and participant-blind pilot study will be conducted to determine the safety and effectiveness of use of a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day. A total of 30 patients were randomly assigned to one of two groups: one group received an active intraoral electrotherapy device and a scaling and root planing (SRP) at baseline, another group received a sham device and a scaling and root planing (SRP) at baseline. The trial was comprised of three in-office oral examinations, which were performed at baseline, and at follow-ups～6 weeks (42 days ± 3 days) and～3months (84 days ± 3 days later). After 3 months of treatment, the effectiveness of the intraoral electrotherapy device would be demonstrated by (1) statistically superior reductions in the probing depth and clinical attachment level compared to treatment with the sham device. (2) statistically superior reductions in the bleeding on probing and gingival index compared to treatment with the sham device.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Maintenance of blinding in this study was facilitated by the fact that (1) treatment delivery (active or sham) was hard-coded into the device's firmware, making active devices physically indistinguishable from sham devices, (2) both the device serial code block sizes and the treatment allocation block sizes were not known by the clinical investigative staff and that the order of blocks in each sequence was random, (3) patients only received treatment with their assigned device (active or sham) at home and never came in contact with another enrolled patient or device other than their own. This scheme rendered deliberate and accidental "breaking of the blind" difficult for both the patients or the clinical investigator, as no comparisons could be made between two devices that delivered different treatments and no pattern linking the device serial code and assigned treatment could be deduced, since the size and the order of blocks were randomly shuffled.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontitis at Stage Ⅲ having:
- •i. Interdental CAL at site of greatest loss ≥5mm ii. Radiographic bone loss extending to mid-third of root and beyond iii. Tooth loss due to periodontitis ≤4 teeth IV. PD ≥ 6mm V. ≥30% of teeth involved
- •Participant has not had any treatment of periodontal disease in the six months
- •Participant is between the ages of 18 and 65 years inclusive.
- •Participant has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
- •Participant is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
排除标准
- •Participant has an implanted electrical stimulation device, such as a cardiac pacemaker, cardiac defibrillator, or deep brain stimulator.
- •Participant with oral cancer or oral mucosal diseases, or oral wound
- •Participant has any of the following:
- •i. Fixed orthodontic appliances; or ii. Any metallic or amalgam crowns and/or restorations that have exposed metallic or amalgam surfaces at the gingival margin on both the buccal and lingual surfaces that, based on the clinical examiner's judgement, would inhibit proper function of the mouthpiece.
- •Participant has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
- •Patients with specific allergic constitution, such as silica gel goods allergy
- •Participant is a smoker
- •Participant is pregnant or plans to become pregnant
- •Participant who have received other clinical research drugs or treatments within 3 months
- •The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.
研究组 & 干预措施
Active group received an active device and a scaling and root planing (SRP) at baseline
干预措施: a noninvasive intraoral electrotherapy device (Device)
Sham group received a sham device and a scaling and root planing (SRP) at baseline
干预措施: a sham device (Device)
结局指标
主要结局
Reductions in the probing depth
时间窗: 3 months
Reductions in the clinical attachment level
时间窗: 3 months
次要结局
- Reductions in the bleeding on probing and gingival index(3 months)