Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

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.
    

Intervention name(s): Sonic Toothbrush; Manual Toothbrush
Intervention type(s): Device; Device
Intervention description(s): Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®); Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocetric, pragmatic, single blinded, randomized clinical trial, parallel design.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Oral Hygiene; Dental Care Instruction