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

Primary Purpose

Periodontal Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

a noninvasive intraoral electrotherapy device

a sham device

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

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
Participant has not had any treatment of periodontal disease in the six months
Participant is between the ages of 18 and 65 years inclusive.
Participant has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

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

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

Arm Description

Outcomes

Primary Outcome Measures

Reductions in the probing depth

Reductions in the clinical attachment level

Secondary Outcome Measures

Reductions in the bleeding on probing and gingival index

Full Information

NCT ID

NCT04793048

First Posted

March 10, 2021

Last Updated

March 10, 2021

Sponsor

Shanghai Keku Medical Technology Co., Ltd.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04793048

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 22, 2021 (Anticipated)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Keku Medical Technology Co., Ltd.

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Maintenance of blinding in this study was facilitated by the fact that (1) treatment delivery (active or sham) was hard-coded into the device's firmware, making active devices physically indistinguishable from sham devices, (2) both the device serial code block sizes and the treatment allocation block sizes were not known by the clinical investigative staff and that the order of blocks in each sequence was random, (3) patients only received treatment with their assigned device (active or sham) at home and never came in contact with another enrolled patient or device other than their own. This scheme rendered deliberate and accidental "breaking of the blind" difficult for both the patients or the clinical investigator, as no comparisons could be made between two devices that delivered different treatments and no pattern linking the device serial code and assigned treatment could be deduced, since the size and the order of blocks were randomly shuffled.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Title

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

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

a noninvasive intraoral electrotherapy device

Other Intervention Name(s)

a scaling and root planing (SRP)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

a sham device

Other Intervention Name(s)

a scaling and root planing (SRP)

Intervention Description

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

Primary Outcome Measure Information:

Title

Reductions in the probing depth

Time Frame

3 months

Title

Reductions in the clinical attachment level

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Reductions in the bleeding on probing and gingival index

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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 Participant has not had any treatment of periodontal disease in the six months Participant is between the ages of 18 and 65 years inclusive. Participant has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation. 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 Participant has an implanted electrical stimulation device, such as a cardiac pacemaker, cardiac defibrillator, or deep brain stimulator. Participant with oral cancer or oral mucosal diseases, or oral wound 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. Participant has disqualifying acute or chronic medical illness as judged by the Principal Investigator. Patients with specific allergic constitution, such as silica gel goods allergy Participant is a smoker Participant is pregnant or plans to become pregnant Participant who have received other clinical research drugs or treatments within 3 months The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhongchen Song

Phone

0086-21-53315841

szhongchen@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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