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

Gingivitis Clinical Trial

— SONIMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558606
• Other study ID #: SONIMAN
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: January 23, 2019

Study information

• Verified date: January 2019
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 23, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Sonic Toothbrush
Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)
• Manual Toothbrush
Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)

Locations

Country	Name	City	State
Italy	Magda Mensi	Brescia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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