A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device
1 other identifier
interventional
30
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedMarch 11, 2021
March 1, 2021
6 months
March 10, 2021
March 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Reductions in the probing depth
3 months
Reductions in the clinical attachment level
3 months
Secondary Outcomes (1)
Reductions in the bleeding on probing and gingival index
3 months
Study Arms (2)
Active group received an active device and a scaling and root planing (SRP) at baseline
ACTIVE COMPARATORSham group received a sham device and a scaling and root planing (SRP) at baseline
SHAM COMPARATORInterventions
a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day
a sham device to be used at-home for 20 minutes a day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 11, 2021
Study Start
March 22, 2021
Primary Completion
September 30, 2021
Study Completion
November 30, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share