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OpenTrials
Completed

NCT Number: NCT04558606

Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up

Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.

The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.

The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.

To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:

* CONTROL: manual toothbrush * TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magda Mensi

Brescia, Lombardy, 25123, Italy

About this study

Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.

TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.

STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.

PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.

SECONDARY OUTCOME:

  • Change in Gingival Index (GI): change in presence or absence of bleeding after gently run on the surface of the marginal gingiva.
  • Change in Recession (REC): change in gingival reduction.
  • Change in Clinical Attachment Level (CAL): change in clinical attachment level.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients affected by gingivitis is defined as bleeding on probing (BOP) > 25%.
  • Healthy young patients (18-40 years)
  • Patients with almost 5 teeth per quadrant
  • Patients smoking less than 10 cigarettes a day

Exclusion criteria

  • Presence of periodontitis (pocket depth - PPD > 4 mm)
  • Patient with BOP and/or plaque index < 25%
  • Patient with any systemic disease
  • Orthodontic or prosthesis patient
  • Patient with split
  • Impossibility to come to the recall appointments
  • Not willing to follow the agreed protocol

Treatment and study plan

Sonic toothbrush

Device

Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)

Manual toothbrush

Device

Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)

Primary outcomes

  1. Change in Plaque Index (PI)

    Time frame: Baseline, 2, 4, 6 weeks and 6, 12 months

    Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits. Change in 10% of the site in test group. 10% site modification in favor of the test group.

Secondary outcomes

  1. Change in Gingival Index (GI)

    Time frame: Baseline, 2, 4, 6 weeks and 6, 12 months

    Change in percentage of site with bleeding after gently run on the surface of the marginal gingiva. Baseline values will be compared to the values recorded in the follow-up visits.

  2. Change in REC (Clinical Gingival Recession)

    Time frame: Baseline 6, 12 months

    Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.

  3. Change in CAL (Clinical Attachment Level)

    Time frame: Baseline 6, 12 months

    Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Acronym: SONIMAN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2020
Registry last updated
Sep 25, 2020

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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