Periodontal DiseasesNCT04793048
A Randomized, Double-blind, Controlled Study to Evaluate the Safety and Feasibility of a Intraoral Electrotherapy Device
A study testing a noninvasive intraoral electrotherapy device in people with Periodontal Diseases, run by Shanghai Keku Medical Technology Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- a noninvasive intraoral electrotherapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis at Stage Ⅲ having:
- 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.
Who cannot join
- 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:
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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).
Read the 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
- Being tested
- a noninvasive intraoral electrotherapy device, a sham device
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a noninvasive intraoral electrotherapy deviceDevice
Also called a scaling and root planing (SRP)
a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day
a sham deviceDevice
Also called a scaling and root planing (SRP)
a sham device to be used at-home for 20 minutes a day
| Study group | Role | What they receive |
|---|---|---|
| Active group received an active device and a scaling and root planing (SRP) at baseline | Active comparator | Not described Receives: Device: a noninvasive intraoral electrotherapy device |
| Sham group received a sham device and a scaling and root planing (SRP) at baseline | Sham comparator | Not described Receives: Device: a sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in the probing depth
Measured: 3 months
Reductions in the clinical attachment level
Measured: 3 months
Secondary outcomes (1)
Reductions in the bleeding on probing and gingival index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start22 Mar 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Keku Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793048
- Sponsor's protocol ID
- 91310110MA1G89RL54
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04793048
- Acronym / sponsor ID
- 91310110MA1G89RL54
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Keku Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 22 Mar 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active group received an active device and a scaling and root planing (SRP) at baseline | Active comparator | Device: a noninvasive intraoral electrotherapy device |
| Sham group received a sham device and a scaling and root planing (SRP) at baseline | Sham comparator | Device: a sham device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Periodontitis at Stage Ⅲ having:
- 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.
Key exclusion criteria (10 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a noninvasive intraoral electrotherapy deviceAlso: a scaling and root planing (SRP)a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day | Device | Active group received an active device and a scaling and root planing (SRP) at baseline |
| a sham deviceAlso: a scaling and root planing (SRP)a sham device to be used at-home for 20 minutes a day | Device | Sham group received a sham device and a scaling and root planing (SRP) at baseline |
Primary outcome
Reductions in the probing depth
Time frame: 3 months
Reductions in the clinical attachment level
Time frame: 3 months
1 secondary outcome
Reductions in the bleeding on probing and gingival index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing a noninvasive intraoral electrotherapy device in people with Periodontal Diseases, run by Shanghai Keku Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongchen Song (0086-21-53315841, szhongchen@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in the probing depth (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021; AzTrials last refreshed its copy on 27 Oct 2026.