Effect of an Anti-inflammatory on Tooth Sensitivity Caused by Bleaching

NCT01300780 | Completed DMC

• 1 other identifier: 17838/2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Perhaps the use of a more selective anti-inflammatory drug, capable of inhibiting enzyme specific for pain may be more effective in preventing the tooth sensitivity caused by the inflammatory response produced by in-office bleaching. To the extent of the authors´ knowledge, no study has so far addressed the use of a selective anti-inflammatory drug specific for pain enzyme on tooth sensitivity, being this the aim of the present investigation.

Conditions

Color Changes During Tooth Formation

Keywords

bleaching agent; tooth bleaching; sensibility

Outcome Measures

Primary Outcomes (1)

• Sensibility

  The effect of the product will be evaluated immediately, 1 Hour, 24 and 48 hours after the teeth bleaching applied to the patients, using a verbal scale of 5 points, also a numerical scale of 101 points will be used, In addition to these two scales a Visual Analogue Scale (VAS, which consists of 10 cm line. One of the extremes presents a "no pain" indication and the other "unbearable pain". Each patient will be directed to mark with a single vertical dash the point that better matches his pain rating at the moment of the evaluation.

  Evaluation of sensibility during the tooth whitening and 24/48 after of the bleaching

Secondary Outcomes (1)

• Colour

  In the first session and second session of the tooth whitening

Study Arms (2)

Experimental

ACTIVE COMPARATOR

The participants from the placebo group received a placebo (Talco pharma SM-200-Henrifarma produtos químicos e farmacêuticos LTDA, São Paulo, SP, Brazil) and participants from the etoricoxib group received a dose of a selective COX- 2 inhibitor etoricoxib 60 mg (Arcoxia, MSD, Campinas, SP, Brazil). All the participants were watched to ensure that they took the drugs or placebo 1 h before treatment. The drugs were similar in appearance. A second dose of placebo or etoricoxib (60 mg) was administered 24 h after the first dose. At the time the participants were required to take the second dose of the medicine, the research auxiliary called him/her and asked him/her to take the medicine.

Drug: Etoricoxib

placebo group

PLACEBO COMPARATOR

The participants from the placebo group received a placebo (Talco pharma SM-200-Henrifarma produtos químicos e farmacêuticos LTDA, São Paulo, SP, Brazil) and participants from the etoricoxib group received a dose of a selective COX- 2 inhibitor etoricoxib 60 mg (Arcoxia, MSD, Campinas, SP, Brazil). All the participants were watched to ensure that they took the drugs or placebo 1 h before treatment. The drugs were similar in appearance. A second dose of placebo or etoricoxib (60 mg) was administered 24 h after the first dose. At the time the participants were required to take the second dose of the medicine, the research auxiliary called him/her and asked him/her to take the medicine.

Other: Placebo

Interventions

Etoricoxib DRUG

Group 2 - experimental Etoricoxib will receive two doses of selective anti-inflammatory to enzyme cyclooxygenase 2 (COX-2) (Etoricoxib 60 mg) given once every 24 hours;

Also known as: Anti-inflamatory

Experimental

Placebo OTHER

Group 1 - Control Group will receive two doses of placebo tablet administered a every 8 hours,

Also known as: Placebo group

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• will be included patients 18 years old and over
• with good general and oral health
• with the eight upper front teeth free of cavities and restorations in the buccal cavity
• The initial color of those teeth must be C2 or dark, comparing with scale Vita Lumin (Vita Zahnfabrik, Bad Säckingen, Germany) organized in order of value.

You may not qualify if:

• shall be excluded patients who underwent any previous form of bleaching procedure
• lactating and pregnant patients
• who relates sensitivity
• severe dental browning (tetracycline staining, fluorosis or endodontics)
• with parafunctional habit or any other type of oral disease
• Still will be excluded patients who have systemic conditions as stomach problems, heart, kidney and liver, or using any continuous drug with anti-inflammatory and antioxidant action.

Sponsors & Collaborators

• Eloisa Andrade de Paula: lead
• Universidade Estadual de Ponta Grossa: collaborator
• Fundação Araucária: collaborator

Study Sites (1)

Universidade Estadual de Ponta Grossa

Guarapuava, Paraná, 84030900, Brazil

Location

Related Publications (2)

• Charakorn P, Cabanilla LL, Wagner WC, Foong WC, Shaheen J, Pregitzer R, Schneider D. The effect of preoperative ibuprofen on tooth sensitivity caused by in-office bleaching. Oper Dent. 2009 Mar-Apr;34(2):131-5. doi: 10.2341/08-33.

  PMID: 19363967 RESULT

• de Paula EA, Loguercio AD, Fernandes D, Kossatz S, Reis A. Perioperative use of an anti-inflammatory drug on tooth sensitivity caused by in-office bleaching: a randomized, triple-blind clinical trial. Clin Oral Investig. 2013 Dec;17(9):2091-7. doi: 10.1007/s00784-013-0918-2. Epub 2013 Jan 31.

  PMID: 23371755 DERIVED

MeSH Terms

Interventions

Etoricoxib

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alessandra Reis, doctor

  Universidade Estadual de Ponta Grossa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 23, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)