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

NCT ID: NCT04793048

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2021-11-30

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active group received an active device and a scaling and root planing (SRP) at baseline

Group Type: ACTIVE_COMPARATOR

a noninvasive intraoral electrotherapy device

Intervention Type: DEVICE

a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day

Sham group received a sham device and a scaling and root planing (SRP) at baseline

Group Type: SHAM_COMPARATOR

a sham device

Intervention Type: DEVICE

a sham device to be used at-home for 20 minutes a day

Interventions

a noninvasive intraoral electrotherapy device

a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day

Intervention Type: DEVICE

a sham device

a sham device to be used at-home for 20 minutes a day

Intervention Type: DEVICE

Other Intervention Names

a scaling and root planing (SRP); a scaling and root planing (SRP)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Shanghai Keku Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhongchen Song

Role: CONTACT

szhongchen@sina.com

0086-21-53315841

Other Identifiers

91310110MA1G89RL54

Identifier Type: -

Identifier Source: org_study_id