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Completed

NCT Number: NCT04640857

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

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

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Key information

Conditions

Oral Hygiene

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silk'n Toothwave

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Probing depth mm

    Time frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

    to measure the pocket depths around the anterior mandibular incisors

  2. Bleeding on probing Yes/No

    Time frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

    to document the presence or absence of bleeding of the dental pocket after probing

  3. Recession mm

    Time frame: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)

    to measure the discrepancy (if existent) between the cementoenamel junction and the free gingival margin in the buccal aspect of the anterior mandibular incisors

  4. Subject satisfaction questionnaire

    Time frame: 4 weeks (T1), after 12 weeks (Tf)

    the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2020
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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