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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Primary Endpoint
- Reductions in the probing depth
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reductions in the probing depth
Time Frame: 3 months
Reductions in the clinical attachment level
Time Frame: 3 months
Secondary Outcomes
- Reductions in the bleeding on probing and gingival index(3 months)