Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03367481 |
| Other study ID # |
Gingival fissures study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2019 |
| Est. completion date |
December 16, 2019 |
Study information
| Verified date |
May 2021 |
| Source |
Federal University of Rio Grande do Sul |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
