Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Change in Plaque score %
Study Overview
Brief Summary
to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus
Detailed Description
Calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque.
Thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus.
The electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic field has an antimicrobial effect.
Electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation.
Previous studies have shown that Silk'n Toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female patient aged 20-85 Years old
- •Subject must have voluntarily signed the informed consent form before any study related action
- •Presence of gingival inflammation (Gingival Index by Silness and Loe 1969)
- •Presence of plaque on clinical crowns (calculation of area)
- •Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline)
- •Compliance with study schedules and arrival at study visits
Exclusion Criteria
- •A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers
- •Pregnant or lactating women (*If Male Please write N/A).
- •Heavy smokers (more than 10 cigarettes per day).
- •Patients with a pacemaker that do not allow the use of an ultrasonic device.
- •Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study).
- •Systemic condition requiring prophylactic antibiotics.
- •Patients taking NSAIDS for prolonged period.
Arms & Interventions
Test group: Silk'n Toothwave with vibration and electromagnetic field
Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months.
Intervention: Silk'n Toothwave (Device)
Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)
Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months.
Intervention: Silk'n Toothwave (Device)
Silk'n Toothwave with an electromagnetic field and without vibration
Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months.
Intervention: Silk'n Toothwave (Device)
Outcomes
Primary Outcomes
Change in Plaque score %
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors
Change in Calculus ratio %
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software
Change in Free gingival margin color (CEILAB color space)
Time Frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space.
Secondary Outcomes
- Probing depth mm(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Bleeding on probing Yes/No(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Recession mm(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Subject satisfaction questionnaire(4 weeks (T1), after 12 weeks (Tf))