Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus

Oral Hygiene Clinical Trial

Official title:

Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640857
• Other study ID #: 0352-20-RMB CTIL
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: June 28, 2022

Study information

• Verified date: April 2023
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Oral Hygiene

Intervention

Device:
• Silk'n Toothwave
patients will receive a non-surgical treatment which will include oral hygiene instructions, calculus removal with ultrasonic and manual instruments. At the end of the meeting they will be provided with a toothbrush which is based on a radiofrequency technology.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Plaque score %	to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Primary	Change in Calculus ratio %	to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Primary	Change in Free gingival margin color (CEILAB color space)	the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space.	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary	Probing depth mm	to measure the pocket depths around the anterior mandibular incisors	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary	Bleeding on probing Yes/No	to document the presence or absence of bleeding of the dental pocket after probing	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary	Recession mm	to measure the discrepancy (if existent) between the cementoenamel junction and the free gingival margin in the buccal aspect of the anterior mandibular incisors	baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
Secondary	Subject satisfaction questionnaire	the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing	4 weeks (T1), after 12 weeks (Tf)