Status:
UNKNOWN
A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device
Lead Sponsor:
Shanghai Keku Medical Technology Co., Ltd.
Collaborating Sponsors:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Periodontal Diseases
Eligibility:
All Genders
18-65 years
Phase:
NA
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 period...
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 period...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04793048
Start Date
March 22 2021
End Date
November 30 2021
Last Update
March 11 2021
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