Evaluation of Gingival Fissures Associated With Soft and Medium Toothbrushes
Condition: Gingival Recession; Gingival Abrasion; Wounds and Injuries
MeSH terms: Gingival Recession; Wounds and Injuries
Study type: Interventional

Summary: 
      Gingival fissures (GF) have been suggested as risk indicators for clinical attachment loss
      (CAL) and gingival recession, especially in free surfaces and in patients with low plaque
      scores. The major factors related to the GF occurrence are high daily brushing frequencies,
      excessive force to brush, malpositioned teeth, use of abrasive dentifrices, and stiffness of
      the toothbrushes bristles. Thus, in order to better understand the pathogenesis and
      progression of GF, this study aim to evaluate the incidence and behavior of GF in young
      adults using soft and medium brushes, in a cross-over randomized clinical trial along 6
      months.
    

Detailed description: 
      Material and Methods: A blinded crossover randomized clinical trial will be conducted with 20
      patients from a school (Colégio Tiradentes da Brigada Militar) at Porto Alegre city, southern
      of Brazil. Patients, aged between 18 to 25 years old, having at least 20 teeth, without
      previous history of periodontitis [clinical attachment loss (CAL) ≥ 3mm], and good systemic
      health will be included if they do not have orthodontic appliances or dental implants, or
      dental caries or restorations at cervical surface. Data collection will performed by two
      trained, calibrated and blinded examiners, and will comprehend a brief interview regarding
      oral hygiene and deleterious habits, full-mouth exams (6 sites/tooth) of Plaque Index (PlI),
      Gingival Index (GI), Pocket Probing Depth (PPD), and CAL, and clinical photographs (from 1st
      and 2nd premolars and 1st molar area in all quadrants) under disclosing solution (2Tone®) to
      evaluate the presence of gingival fissures (GF). After baseline data collection the
      participants will be randomized in one of the experimental groups according the toothbrush
      bristles stiffness: G1) soft; or G2) medium. No oral hygiene instruction will be provided to
      groups, and the patients will not be informed about the type of brush that will be provided.
      Re-exams (PlI, GI and photographs) will be conducted at 30, 60, 90 days. At day 90 the 1st
      phase will be finished, and the participants will have a 10-days wash-out period. At day 100,
      the 2nd phase will start, and the participants will change the groups. Re-exams will be
      conducted at 130, 160, 190 days. At day 190, the study will be finished. The participants
      will be oriented to return the toothbrushes used at the end of each experimental phase.

      Outcomes: The primary outcome will be the number of participants with GF observed over the
      study period. Also, the incidence, size and duration of the GF will be compared regarding the
      variables: type of bristle, self-reported toothbrushing frequency, toothbrush deformation,
      and deleterious habits. McNemar test will be used to compare the frequencies of patients with
      GF and the number of lesions observed both inter and intra-groups. Uni- and multivariate
      regression models will be conducted to determine associations between the outcome and
      independent variables. The mean number of new fissures, GF that decreased, and GF that
      stabilized over time will be compared inter-groups as secondary analysis. Intention-to-treat
      analysis will be conducted, considering the individual the unit of analysis and a α-error of
      0.05.
    

Intervention name(s): Toothbrush type
Intervention type(s): Device
Intervention description(s): In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Gingival fissures; Gingival recession; Risk factors; Traumatic toothbrushing