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

NCT04558606 | Completed DMC

• 1 other identifier: SONIMAN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis

Keywords

Oral Hygiene; Dental Care Instruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Gingival Index (GI)

  Baseline, 2, 4, 6 weeks and 6, 12 months

• Change in REC (Clinical Gingival Recession)

  Baseline 6, 12 months

• Change in CAL (Clinical Attachment Level)

  Baseline 6, 12 months

Study Arms (2)

Sonic toothbrush

EXPERIMENTAL

* 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

Manual toothbrush

ACTIVE COMPARATOR

* 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

Interventions

Sonic Toothbrush DEVICE

Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)

Sonic toothbrush

Manual Toothbrush DEVICE

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

Manual toothbrush

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: January 8, 2018
• Primary Completion: January 23, 2019
• Study Completion: January 23, 2019
• Last Updated: September 25, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)