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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Device: a noninvasive intraoral electrotherapy device; Device: a sham device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongchen Song; Phone Number: 0086-21-53315841; Email: szhongchen@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active group received an active device and a scaling and root planing (SRP) at baseline	Device: a noninvasive intraoral electrotherapy device; a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day; Other Names: a scaling and root planing (SRP)
Sham Comparator: Sham group received a sham device and a scaling and root planing (SRP) at baseline	Device: a sham device; a sham device to be used at-home for 20 minutes a day; Other Names: a scaling and root planing (SRP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reductions in the probing depth	3 months
Reductions in the clinical attachment level	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Reductions in the bleeding on probing and gingival index	3 months

Collaborators and Investigators

• Sponsor: Shanghai Keku Medical Technology Co., Ltd.
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 22, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: 91310110MA1G89RL54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No