Clinical trial NCT04640857: Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus
Official title: Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Keywords: Electromagnetic Fields
Oral Hygiene
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Silk'n Toothwave
Primary purpose: PREVENTION

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 aim: to asses the effect of the electromagnetic field in a tooth brush (Silk'n Toothwave) on calculus accumulation and gingival parameters.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Plaque score %
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
measure: Change in Calculus ratio %
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
measure: Change in Free gingival margin color (CEILAB color space)
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary outcomes:
measure: Probing depth mm
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
measure: Bleeding on probing Yes/No
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
measure: Recession mm
timeFrame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
measure: Subject satisfaction questionnaire
timeFrame: 4 weeks (T1), after 12 weeks (Tf)
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Dept. of Periodontology
Study officials:
affiliation: Rambam Health Care Campus
name: Hadar Zigdon, DMD
role: PRINCIPAL_INVESTIGATOR
References: