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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Device: Sonic Toothbrush; Device: Manual Toothbrush

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Magda Mensi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonic toothbrush; All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction).; Each patient is instructed by the hygienist in the correct use of the sonic toothbrush	Device: Sonic Toothbrush; Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)
Active Comparator: Manual toothbrush; All patients receive full periodontal charting, a session of professional oral hygiene and OHI (oral hygiene instruction).; Each patient is instructed by the hygienist in the correct use of the manual toothbrush	Device: Manual Toothbrush; Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plaque Index (PI)	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.	Baseline, 2, 4, 6 weeks and 6, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Index (GI)	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.	Baseline, 2, 4, 6 weeks and 6, 12 months
Change in REC (Clinical Gingival Recession)	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.	Baseline 6, 12 months
Change in CAL (Clinical Attachment Level)	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.	Baseline 6, 12 months

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Investigators: Principal Investigator: Magda Mensi, ASST Spedali Civili Di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): January 23, 2019
• Study Completion (Actual): January 23, 2019

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Oral Hygiene; Dental Care Instruction
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: SONIMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No