Clinical trial NCT04558606: Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
Official title: Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Oral Hygiene
Dental Care Instruction
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Plaque Index (PI)
timeFrame: Baseline, 2, 4, 6 weeks and 6, 12 months
Secondary outcomes:
measure: Change in Gingival Index (GI)
timeFrame: Baseline, 2, 4, 6 weeks and 6, 12 months
measure: Change in REC (Clinical Gingival Recession)
timeFrame: Baseline 6, 12 months
measure: Change in CAL (Clinical Attachment Level)
timeFrame: Baseline 6, 12 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Magda Mensi
state: Lombardia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Magda Mensi
role: PRINCIPAL_INVESTIGATOR
References: