Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
Phase: NA
Conditions: Gingivitis
Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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Title 
 
Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® compared to manual brushing in 
healthy patients: a 12 mouth randomized clinical trial. 
Author 
 
Introduction 
Professional oral hygiene has become a customary procedure in everyday dentistry. Both 
manual and sonic brushes are part of normal oral hygiene education practice. The aim is the 
removal of biofilm, plaque and calculus from the dental surface. 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. 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 our study would validate efficacy of toothbrushes post-causal therapy, 
towards lower plaque accumulation, and reduction in bleeding. 
 
Aim 
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. 
 
Materials and Methods  
Trial design:  
Monocetric, pragmatic,  single blinded, randomized clinical trial (RCT) of parallel design.  
The trial will have one-year duration. 
 
Participants:  
Healthy subject affected by gingivitis are included in the study. The patients are treated at the 
Department of Surgical Specialties, Radiological Science and Public Health, School of 
Dentistry, Section of Periodontics, Brescia, Italy between the period 01/10/2017 - 

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01/10/2019. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%. 
Inclusion criteria are: 
- 
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 are: 
- 
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 
 
A written informed consent will be obtained from each patient included after explanation of 
the risks and benefits of participating in this study. No change in the trial design will be made 
after approval of the Ethics Committee.  
 
Intervention 
Age, sex, smoking habits should be recorded. At Baseline examination taken by (RA) the 
following periodontal index will be recorded at 6 sites per tooth. 
- 
P.P.D: measured from the gingival margin to the bottom of the pocket.  
- 
G.I. recorded as presence or absence of bleeding after gently run on the surface of the 

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marginal gingiva. 
- 
PI: recorded as presence or absence of plaque. A probe will gently run on the surface of 
the teeth.  
- 
REC: measured from the cement-enamel junction to the gingival margin. 
- 
CAL: measured clinically from the base of the pocket to the cement-enamel junction 
A PCP-UNC 15 periodontal probe is used on six sites per tooth (mesio-buccal, buccal, disto-
buccal, mesio-lingual, lingual and disto-lingual) with a gentle probing force by the same 
examiner. Measurements are rounded to the nearest millimetre. 
Examiner calibration: 
The examiner should be calibrated measuring PPD and PAL in one quadrant with at least 6 
teeth on 10 patients. Measurements should be repeated after one hour and variability should 
be assessed 
After baseline recording (RA), a professional oral hygiene (full mouth erythritol powder air 
polishing therapy – FM-EPAPT)  will be done by VB. 
After ultrasonic debridment the randomization envelope will be open by VB. 
Group A: sonic toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®) will be given 
Group B: Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL) will be given. 
For each group specific instruction of oral hygiene will be done. 
For all patient are recommended: toothbrush Hydral Gum (GUM® Sunstar Italiana SRL) and 
interdental floss (GUM® Sunstar Italiana SRL) 
 
Each patient is recalled at 2 and 4 weeks to reinforce oral hygiene instructions (VB) and do 
collect GI and PI (RA). 
Furthermore, all patients are recalled at 6 weeks 6 and 12 months for update of periodontal 
folder (RA); at 6 and 12 months professional hygiene will be done by VB. 
At the end of the therapy reinforcement of oral hygiene instruction are given by VB.  

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Primary Outocome: 
Change in P.I..: change in 10% of the site in test group. 
Secondary Outcomes: 
Change in G.I.: change in presence or absence of bleeding after gently run on the surface of 
the marginal gingiva. 
Change in R.E.C.: change in gingival reduction. 
Change in C.A.L.: change in clinical attachment level. 
 
Sample size determination 
We assumed that count of sites with plaque within patient can be described by a Poisson 
distribution. Assuming a fixed number of sites per patient (N=48) we can model the data 
using a Poisson-rate model and therefore estimate the number of patients needed to achieve 
approximately 10% reduction (as a difference between rates) in the P.I. rate between the two 
treatments, corresponding to approximately 30% proportional reduction. For simplicity we 
considered only the effect at the latest time point. The we simulated  Poisson counts for a set 
of candidate sample size assuming a drop from a 25% rate (12/48) to 17% (8/48) and 
modelled the data using a Poisson regression (GLM with Poisson family). We performed the 
simulation 500 times and computed the proportion of time the coefficient for the two group 
comparison had a p-value lower than 5%. A sample size of  16 for each groups allowed a 
power of at least 90%. 
Statistical Analysis Plan 
Data will be aggregated within patient to compute the number of site with plaque over the 
total number of probed sites (i.e. P.I.). Counts will be modelled using a Poisson rate model 
(GLMM with Poisson family) and setting the total number of site per patient as offset. A 
significance level of 5% will be used and all the analysis will be performed using the software 
R. 
Randomization 
Patients will be randomized to either treatment using a computer generated sequence based 
on a blocked randomization procedure. The software used will be R. 
Summary of the procedures: 

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Baseline:  
- clinical measurements: PPD, PI, GI, REC, CAL. 
- FM-EPAPT 
- randomization 
- education and motivation 
2/4 weeks: 
- education and motivation 
- checking compliance 
- GI and PI 
6 weeks: 
- education and motivation 
- checking compliance 
- clinical measurements: PPD, PI, GI, REC, CAL. 
6/12 months:  
- clinical measurements: PPD, PI, GI, REC, CAL. 
- FM-EPAPT 
- checking compliance 
- education and motivation 
Drop-outs: 
All drop-outs should be reported and the reason for dropping out should be investigated and 
reported per study group. 
 
Publication plan: 
2, 6 and 12 months results