A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device
- Conditions
- Periodontal Diseases
- Interventions
- Device: a noninvasive intraoral electrotherapy deviceDevice: a sham device
- Registration Number
- NCT04793048
- Lead Sponsor
- Shanghai Keku Medical Technology Co., Ltd.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active group received an active device and a scaling and root planing (SRP) at baseline a noninvasive intraoral electrotherapy device - Sham group received a sham device and a scaling and root planing (SRP) at baseline a sham device -
- Primary Outcome Measures
Name Time Method Reductions in the probing depth 3 months Reductions in the clinical attachment level 3 months
- Secondary Outcome Measures
Name Time Method Reductions in the bleeding on probing and gingival index 3 months