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

NCT03343392 | Completed Phase 3

• 1 other identifier: 45733615.6.0000.0109
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hydrogen Peroxide Allergy

Keywords

Hydrogen Peroxide; Analgesics; Tooth Bleaching

Outcome Measures

Primary Outcomes (1)

• Absolute risk of tooth sensitivity (TS)

  The TS was evaluated during bleaching to 48 h post-bleaching. The patient was asked to binary outcome if the sensitivity is present ou not present.

  48 hours

Secondary Outcomes (2)

• Intensity of TS

  48 hours

• Color

  30 days

Study Arms (2)

acetam/ketoro tromet group

EXPERIMENTAL

One hour before in-office bleaching patients received either the acetaminophen 750 mg (Paracetamol 750 mg, Bioativa compounding pharmacy) and ketorolac tromethamine oral 10 mg (Toragesic® 10 mg, EMS Sigma Farma). The operator administered the first dose of drug 1 h before the protocol, and extra doses were administered every 8 h for 48 h to keep a safe maximum daily dosage of 4000 mg of acetaminophen and 40 mg of ketorolac tromethamine.

Drug: acetam/ketoro tromet group

Placebo group

PLACEBO COMPARATOR

One hour before in-office bleaching patients received either placebo.

Drug: Placebo group

Interventions

acetam/ketoro tromet group DRUG

One hour before in-office bleaching patients received either the acetaminophen 750 mg (Paracetamol 750 mg, Bioativa compounding pharmacy) and ketorolac tromethamine oral 10 mg (Toragesic® 10 mg, EMS Sigma Farma). The operator administered the first dose of drug 1 h before the protocol, and extra doses were administered every 8 h for 48 h to keep a safe maximum daily dosage of 4000 mg of acetaminophen and 40 mg of ketorolac tromethamine.

acetam/ketoro tromet group

Placebo group DRUG

One hour before in-office bleaching patients received either placebo,The operator administered the first dose of drug 1 h before the protocol, and extra doses were administered every 8 h for 48 h.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Estadual de Ponta Grossa: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Universidade Estadual do Oeste do Paraná: collaborator

Study Sites (1)

Eloisa Andrade de Paula

Santos, São Paulo, 11045551, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This was a triple-mask study, in which the patient, operator and evaluator were blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor.

Model Details: This was a randomized, parallel, placebo-controlled, triple-mask clinical trial, in which the patient, operator and evaluator were masked to the group assignment. A third researcher, not involved in the evaluation process, was responsible for the randomization process, and delivery and guidance on the administration of the drugs. This study was performed from 01/2016 to 12/2017 in the city of Cascavel (Paraná, Brazil). All bleaching procedures were carried out within the Clinics of the Dental School of the State University of Oeste do Paraná (Cascavel, Paraná, Brazil).

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 17, 2017
• Study Start: November 5, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)