RBR‐235jts.
Study name | Dental sensitivity: prevalence and treatment |
Methods | Parallel, prospective, double‐blinded, 4‐arm, RCT This project is subdivided into 4 studies: the Orto1 and Perio1 studies are observational studies; the Orto2 and Perio2 studies are clinical researches. All interventions consist of topical application of substances for treatment of cervical dentine hypersensitivity |
Participants | Inclusion criteria: ‐ Orto2 study: patients older than 18 years; completed corrective orthodontic treatment; permanent dentition erupted prior to orthodontic treatment; agree to participate; good general health; clinically diagnosed dentine hypersensitivity ‐ Perio2 study: patients older than 18 years; completed non‐surgical periodontal treatment; agree to participate; good general health; clinically diagnosed dentine hypersensitivity Exclusion criteria: ‐ Orto2 study: in orthodontic retreatment; use of anti‐inflammatory, analgesic and/or psychiatric medications (chronic or up to 72 hours prior to clinical evaluations); pregnant or lactating women; carious lesions; endodontic treatment; pulp and/or periapical lesion; in treatment for dentine hypersensitivity; who underwent periodontal surgery in the last 3 months; restored in the last 3 months; fixed or removable prosthetic abutments; with prosthetic crowns; extensively restored; restorations covering the cervical region and/or regions that interfere with the assessment of dentine hypersensitivity; allergic to the components of the formulations that will be used ‐ Perio2 study: use of anti‐inflammatory, analgesic and/or psychiatric medications (chronic or up to 72 hours prior to clinical evaluations); pregnant or lactating women; carious lesions; endodontic treatment; pulp and/or periapical lesion; in treatment for dentine hypersensitivity; who underwent periodontal surgery in the last 3 months; restored in the last 3 months; fixed or removable prosthetic abutments; with prosthetic crowns; extensively restored; restorations covering the cervical region and/or regions that interfere with the assessment of dentine hypersensitivity; allergic to the components of the formulations that will be used |
Interventions | The groups of interventions of Orto2 and Perio2 studies are: Group 1: placebo group (PL): 26 individuals in each trial; application of nitrocellulose varnish and LED light in the buccal cervical region in 3 points (1 mesial point, 1 midpoint, and 1 distal point) perpendicular to the long axis of the tooth, each application will last 30 s Group 2: potassium oxalate (OX) group: 26 individuals in each trial; application of potassium oxalate and LED light in the buccal cervical region in 3 points (1 mesial point, 1 midpoint, and 1 distal point) perpendicular to the long axis of the tooth, each application will last 30 s Group 3: laser group (LA): 26 individuals in each trial; application of nitrocellulose varnish and low‐power laser semiconductor diode GaAIAs and InGaAIP in the buccal cervical region in 3 points (1 mesial point, 1 midpoint, and 1 distal point) perpendicular to the long axis of the tooth, each application will last 30 s Group 4: bioglass group (BV): 26 individuals in each trial; application of experimental bioglass containing K and Sr in vehicle of nitrocellulose varnish and LED light in the buccal cervical region in 3 points (1 mesial point, 1 midpoint, and 1 distal point) perpendicular to the long axis of the tooth, each application will last 30 s The treatments will be applied in 3 moments, with intervals of 72 hours between them, that is, 3 treatment applications will be performed for each patient, within their respective group |
Outcomes | Primary output for Orto2 and Perio2 studies: HSDC values measured by the evaporative (air blast) and tactile (clinical probe) stimuli method using the NRS pain scale from 0 to 10 (where 0 corresponds to 'no pain' and 10 corresponds to 'worst pain imaginable'), so that the experimental bioglass group might have similarity with the HSDC values measured for the groups that used laser and the groups that used potassium oxalate |
Starting date | 05 January 2019 |
Contact information | Ana Cláudia Dalmolin, anaclaudiadalmolin@gmail.com |
Notes | ‐ |
CPP‐ACP = casein phosphopeptide amorphous calcium phosphate; Er:YAG = erbium:yttrium‐aluminum‐garnet; GaAIAs = gallium‐aluminum‐arsenide; Hz = hertzs; InGaAIP = indium‐gallium‐aluminum phosphide; LLLT = low‐level laser therapy; Nd:YAG = neodymium‐doped:yttrium‐aluminum‐garnet; nm = nanometers; NRS = numerical rating scale; RCT = randomized controlled trial; s = second; VAS = visual analogue scale; W = watt.