The Effect of Different Drugs in the Prevention of Tooth Sensitivity Caused by Tooth Bleaching Treatment.

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: The administration of the intra-oral drugs was not capable of reducing this side effect, maybe the use of two analgesics may to present better analgesic effect to avoid the bleaching-induced tooth sensitivity (TS). Methods: A triple-blind, parallel-randomized clinical trial was conducted with 114 health patients who received either a placebo or an association of ketorolac tromethamine/acetaminophen. The first doses of two analgesic (Acetaminophen 750 mg/ Ketorolac Tromethamine 10 mg) or placebo was administered 1 h before the in-office bleaching (35% hydrogen peroxide), and extra doses were administered every 8 h for 48 h. The TS was recorded using 0-10 visual analog scale and a 0-4 numeric rating scale in different periods: during bleaching and from 1 h up to 6h, from 12 h up to 18h, from 18h up to 24 h, from 24h up to 48 h post-bleaching. The color was measured before and one month after dental bleaching with a visual shade guide Vita Classical, Vita Bleachedguide 3D-Master and spectrophotometer Vita Easyshade (Vita Zahnfabrik). The absolute risk of TS was evaluated by Fisher's exact test. Data of TS intensity with NRS scale of the two groups were compared with Mann-Whitney and Friedman tests, while data from the VAS scale were evaluated by two-way repeated measures ANOVA and Tukey's test for pairwise comparison. The color changes between groups were compared using a Student t-test (α = 0.05).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidade Estadual de Ponta Grossa
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Universidade Estadual do Oeste do Paraná
• Treatments: Acetaminophen; Analgesics; Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Patients were at least 18 years old.

• Patients had good general and oral health, and did not report any type of tooth sensitivity (TS).

• The participants were required to have six caries-free maxillary anterior teeth and without restorations, absence of periodontal disease and must reviewed and signed the informed consent form.

• The central incisors should be shade A2 or darker as judged by comparison with a value-oriented shade guide (Vita Classical, Vita Zahnfabrik, Bad Säckingen, Germany).

Exclusion Criteria:

• Participants with anterior restorations or dental prosthesis, with orthodontics apparatus, with severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth) were not included in the study.

• Pregnant/lactating women, participants with any other pathology that could cause sensitivity (such as recession, dentine exposure, presence of visible cracks in teeth), taking anti-inflammatory and/or analgesic drugs, smokers, bruxists or participants that had undergone tooth-whitening procedures were also excluded.

• Patients that reported some earlier or present health problems in stomach, heart, kidney and liver, participants reporting continuous use of anti-inflammatory and/or analgesic drugs were excluded.

• Diabetics, hypertensive or patients with known allergy to acetaminophen and lactose.