Effect of topical Dipyrone application in tooth sensitivity caused from In Office Dental Bleaching

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8qdf7t
• Date of registration: 29/01/2016
• Prospective Registration: No
• Primary sponsor: Universidade Estadual de Ponta Grossa - UEPG
• Public title: Effect of topical Dipyrone application in tooth sensitivity caused from In Office Dental Bleaching
• Scientific title: Effect of the use of topical Dipyrone in tooth sensitivity resulting from In Office Dental Bleaching - : Dental Bleaching, Dentin Sensitivity, Dipyrone
• Date of first enrolment: 27/12/2015
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8qdf7t
• Study type: Intervention
• Study design: Triple-blind clinical trial of treatment (safety and efficacy), randomized controlled, within person, blind triple, two arms design
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Alessandra Reis
• Affiliation: Universidade Estadual de Ponta Grossa - UEPG

• Name: Alessandra Reis
• Affiliation: Universidade Estadual de Ponta Grossa - UEPG

Key inclusion & exclusion criteria

Inclusion criteria: Patients older than 18 years are included; with good oral and general health; with the maxillary anterior teeth free restorations and presenting no carious lesion; which possess the color of teeth A2 or darker depending on the color scale Vita Classical (Vita Zahnfabrik, Bad Säckingen, Germany) and to agree with the free and informed consent form.
Exclusion criteria: Patients will be excluded who have already performed dental whitening, pregnant patients or lactating; who report tooth sensitivity; severe browning (staining by tetracycline, fluorosis or endodontics); with deleterious habits; people with dental prostheses and orthodontic appliances and any other oral pathology. Although patients will be excluded that present systemic changes such as stomach, heart, kidney and liver problems; diabetes; hypertension or are making continual use of drugs with analgesic and anti-inflammatory or who have allergies to Dipyrone.

Age minimum:
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

E06.420.750

Dentin sensitivity, Tooth bleaching

C07.793.266

Intervention(s)

Other

Drug

D03.383.129.539.850.077.150

It will be a study the split-mouth type.
Experimental group: For one hundred twenty volunteers will be applied on the buccal surface of the teeth of a hemi arch (upper and lower) the desensitizing for topical use containing dipyrone. The desensitizing will be applied in an active manner in the tooth surface for 20 seconds on each tooth with the aid of a disposable brush and will passively to complete 10 minutes. After this period the drug will be removed with a gauze, washed and will start the tooth whitening.

Control group: For the same one hundred twenty patients received placebo gel is used topically, but on the other hemi arch (upper and lower). The desensitizing will be applied in an active manner in the tooth surface for 20 seconds on each tooth with the aid of a disposable brush and will passively to complete 10 minutes. After this period the drug will be removed with a gauze, washed and will start the tooth whitening.

Primary Outcome(s)

Expected outcome 1: Number of patients that report spontaneous pain in any moment of the bleaching protocol and up to 48 h post-bleaching, through self-report. This number will be presented as percentage of patients with tooth sensitivity and will be named absolute risk of tooth sensitivity.

Result obtained 1: The topical application of dipyrone was not able to reduce the absolute risk of dental sensitivity. No statistically significant difference was found between the groups in relation to absolute risk (Dipyrone group 83% and placebo group 90%, p = 0.09). Patients self-reported spontaneous pain at some time during the dental bleaching technique and up to 48 hours after the procedure.

Secondary Outcome(s)

Expected outcome 2: The intensity of tooth sensitivity will be assessed using the numeric 5-point scale (NRS 0-4), the values presented as median (1st and 3rd interquartile intervals) and the visual analogue scale (VAS 0-10) and will be presented as means and standard deviations; in different periods (during dental bleaching, up to 1 h, 1 h to 24 h and 24 h to 48 h post-bleaching).

Expected outcome 3: The difference in color between the baseline condition and 1 month post-bleaching will be assessed by Vita Classical and Bleachedguide Vita shade guide as well as with the Vita Easyshade spectrophotometer. The data will be presented as means and standard deviations.

Expected outcome 3: Topical application of dipyrone does not interfere with the effectiveness of tooth whitening. The results of the analyses using scales Vita Classical (Dipyrone group 4.3 ± 2.5 and placebo group 4.5 ± 2.4, p = 0.30); Vita Bleachedguide (Dipyrone group 7.6 ± 3.0 and placebo group 7.5 ± 3.0, p = 0.93) and the spectrophotometer (Dipyrone group 6.1 ± 3.2 and placebo group 6.1 ± 2.7, p = 0.93) matched the hypothesis of equality between the groups after bleaching.

Result obtained 2: Topical application of dipyrone was not able to reduce the intensity of dental sensitivity. The tooth sensitivity data under the two pain scales (NRS e VAS), were statistically similar, except from the period up to 1 h, where a significant difference (p = 0.02), was detected favoring the dipyrone group. When using the NRS scale, the following results were found: immediately (dipyrone group: 0 (0/0) and placebo group 1 (0/2), p = 0.76); up to 1 h (Dipyrone group: 1 (0/2) and placebo group 1 (0.5 / 2), p = 0.02); up to 24 h (dipyrone group: 1 (0/2) and placebo group 1 (0/2), p = 0.88) and up to 48 h (Dipyrone group: 0 (0/0) and placebo group 0 (0 / 0), p = 0.79). When using the VAS scale, the following results were found: immediately (dipyrone group: 1.7 ± 2.5 and placebo group 1.8 ± 2.4, p = 0.92); up to 1 h (Dipyrone group: 2.3 ± 2.7 and placebo group 2.6 ± 2.8, p = 0.09); up to 24 h (dipyrone group: 1.6 ± 2.3 and placebo group 1.8 ± 2.5, p = 0.17) and up to 48 h (Dipyrone group: 0.4 ± 1.0 and placebo group 0.3 ± 1.0, p = 0.07).

Source(s) of Monetary Support

Universidade Estadual de Ponta Grossa - UEPG

Secondary Sponsor(s)

Universidade Estadual de Ponta Grossa - UEPG