Clinical trial NCT04793048: A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Shanghai Keku Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2021-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial was a parallel-arm, sham-controlled, randomized, and double-blind pivotal trial. 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. 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
2. Participant has not had any treatment of periodontal disease in the six months
3. Participant is between the ages of 18 and 65 years inclusive.
4. Participant has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
5. Participant is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.

Exclusion Criteria

1. Participant has an implanted electrical stimulation device, such as a cardiac pacemaker, cardiac defibrillator, or deep brain stimulator.
2. Participant with oral cancer or oral mucosal diseases, or oral wound
3. 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.
4. Participant has disqualifying acute or chronic medical illness as judged by the Principal Investigator.
5. Patients with specific allergic constitution, such as silica gel goods allergy
6. Participant is a smoker
7. Participant is pregnant or plans to become pregnant
8. Participant who have received other clinical research drugs or treatments within 3 months
9. The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.

Primary outcomes:
measure: Reductions in the probing depth
timeFrame: 3 months
measure: Reductions in the clinical attachment level
timeFrame: 3 months
Secondary outcomes:
measure: Reductions in the bleeding on probing and gingival index
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: