Ortiz 2019.
| Study characteristics | ||
| Methods |
Study type: RCT (4 parallel groups) Duration of trial: 1 June to 20 October 2018 Duration of follow‐up: 1 month |
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| Participants |
Setting: Federal University of Para (UFPA), Brazil Inclusion criteria: patients with at least 2 sensitive teeth with a response ≥ 4 on the 10 cm length VAS (0: no pain and 10: unbearable pain) after tactile and evaporative stimulation and/or the presence of a non‐carious lesion up to 2 mm deep, and/or class I gingival recession Exclusion criteria: patients with allergies to milk proteins; systemic diseases; carious lesions and/or pulpitis; presence of restorations on sensitive teeth; periodontal disease; cracks in the enamel; fixed orthodontic treatment; pregnant or nursing women; medication with analgesics or anti‐inflammatories or have received desensitizing treatment during the 3 months prior to the recruitment date Total number: 24 patients were enrolled. 21 participants (87.5%) with 80 teeth completed all phases of the study Age range: 18 to 50 years. The mean age was 30 years (SD = 8.13) Sex (M/F): 6/15 |
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| Interventions | Participants were allocated into 4 groups Group 1: CPP‐ACPF group Details: CPP‐ACPF group participants received the MI Paste Plus application following the placebo group protocol, the PBM was simulated in the same way Group 2: PBM group Details: the placebo paste was applied as previously described and the laser was applied using an infrared light spectrum with a wavelength of 808 nm, positioning its tip at the previously described points (60 J/cm2 at each point) for 16 s Group 3: CPP‐ACPF + PBM group Details: MI Paste Plus and PBM were applied following the CPP‐ACPF and PBM protocols Group 4: placebo group Details: the placebo group received a water‐based base paste application with a microbrush (Microbrush, 3M ESPE) on the cervical vestibular surfaces of each tooth for 5 minutes that was later rubbed for 20 s with a rubber cup (Prophy Cup, MICRODONT) coupled to a low speed handpiece (Contra angle 500, Kavo). Followed by PBM simulation, that was carried out by positioning the laser tip at 2 points of each tooth, 1 at the center of the cervical region and another 1 in the middle third of the crown without light emission. The sound of the equipment was mimicked by an applicative on the cell‐phone (Beep, FoncannonInc) |
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| Outcomes | Responses to tactile and air blast stimuli (VAS with the value range between 0 and 10) and dentine hypersensitivity experience questionnaire (DHEQ) Details: dentine hypersensitivity evaluation was performed by requesting the participant to signal a compatible number to their pain sensation on the VAS after 2 stimuli: tactile was performed by sliding an exploratory probe in a cross‐shaped way into the cervical region of the tooth. Evaporative consisted of the application of an air blast from a triple syringe for 3 s at a pressure of 40 psi (20 ± 3˚C), perpendicularly to the buccal surface of the tooth (0.5 cm distance), the adjacent teeth were protected with cotton rolls Dentine hypersensitivity was recorded in 5 moments: 1st registration: before starting the 1st treatment session; 2nd registration: after the 1st treatment session; 3rd registration: after the 2nd treatment session (24 hours after the 1st treatment session); 4th registration: after the 3rd treatment session (24 hours after the 2nd treatment session); and 5th registration: after 1 month of follow‐up The participants’ self‐reported evaluation was performed by giving them a questionnaire (DHEQ) before the start and after 1‐month follow‐up to determine the treatment impact on their HRQL [25,26]. Its summarized version consists of 15 questions that are answered according to a 7‐point Likert scale. Higher scores indicate a poorer HRQL |
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| Notes |
Baseline characteristics: quote: "All the participants received a toothbrush with soft bristles (Top Plus, Condor) and a dentifrice without a desensitizing action (EVEN Baby, Raymundo da Fonte) with oral hygiene instructions. Three desensitizing treatment sessions were performed with a 24‐hour interval between each session" Sample size calculation: quote: "The data obtained in a pilot study were introduced into the G Power1 program (Heinrich‐Heine‐Universitat Dusseldorf, Germany), with a statistical power of 80%, a probability of error α of 5%, and effect size f estimative of 1.35 a total of 08 teeth per arm would be necessary" Source of funding: quotes: "The study was supported in part by scholarships for postgraduate students of the Organization of American States (OAS), the Coordination for the Improvement of Higher Education Personnel (CAPES) ‐ Finance Code 001. However, the study was not directly funded." "The authors declare no potential conflicts of interest with respect to the authorship and/or publication of this article. This study was supported by infrastructural maintenance by the National Council for Scientific and Technological Development (CNPq) and the Federal University of Para" Ethics approval: quote: "This RCT was approved by the health of science institute of ethics research committee of the University Federal of Para (Approval number: 2.858.288 S1 Protocol) and was registered on the clinical trials registry" Informed consent: quote: "After being duly informed about the risks and methods of this study, all the participants signed an informed written consent in accordance with the Declaration of Helsinki" Adverse events: not mentioned in the study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "One of the research collaborators performed a block randomization using a numerical draw which allowed each participant to be allocated into one of the four groups under different arrangements (A4,1; A3,1; A2,1 and A1,1)" |
| Allocation concealment (selection bias) | Low risk | Quote: "The allocation concealment was maintained since the numerical draw was performed using numbered and coded papers. The code for each group was unknown by all: participants, principal investigator, clinical operator, and evaluator" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Participants were unaware of the desensitizing treatment received because both pastes were contained in similar recipients hindering visual identification and the texture, color and odor of the placebo was similar to MI Paste Plus" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The evaluator was not aware of the group to which the participant belonged" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up of 3 out of 24 patients was reported in the study |
| Selective reporting (reporting bias) | Low risk | All intended outcomes were reported in the study |
| Other bias | Low risk | The study appears to be free of other sources of bias |