NCT04793048

A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Keku Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
DEVICE	a noninvasive intraoral electrotherapy device	a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day
DEVICE	a sham device	a sham device to be used at-home for 20 minutes a day

Timeline

• Start date: 2021-03-22
• Primary completion: 2021-09-30
• Completion: 2021-11-30
• First posted: 2021-03-11
• Last updated: 2021-03-11