A Randomized, Double-blind, Controlled Study to Evaluate the Safety &

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Periodontal Diseases

Clinical Trial Details

NCT number	NCT04793048
Study type	Interventional
Source	Shanghai Keku Medical Technology Co., Ltd.
Contact	Zhongchen Song
Phone	0086-21-53315841
Email	szhongchen@sina.com
Status	Not yet recruiting
Phase	N/A
Start date	March 22, 2021
Completion date	November 30, 2021

View Details

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms