Anti-inflammatory Steroids in the Prevention of Tooth Sensitivity

NCT02956070 | Completed Results

• 1 other identifier: bleaching
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical randomized, triple-blind, used to measure the level of tooth sensitivity on volunteers using a modified virtual analog scale (VAS). Sixty-six volunteers will be selected and recruited, following inclusion criteria and pre-established exclusion. All volunteers will be guided and sign a term of clarification and consent. Volunteers will be randomly divided into two groups: the control group to receive placebo capsules and application of desensitizing gel containing 6% potassium nitrate and 0.10% fluoro- (conventional treatment) and the experimental group will receive the anti-inflammatory corticosteroids (dexamethasone, capsule - 8mg) and application of a placebo gel. Patients will be treated in two clinical sessions with an interval of 7 days (one week) between them. The protocol for use of the product is as follows: The volunteers in the experimental group will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am in the morning two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before the first practice session whitening, 8 mg (1 capsule) to 9 am on the day of the first practice session of whitening. After 7 days (one week), the same protocol will be held for the second and final practice session office bleaching.

Conditions

Inflammation

Keywords

dental bleaching; antiinflammatory; tooth sensitivity

Outcome Measures

Primary Outcomes (3)

• Visual Analogic Scale (0-100) for Tooth Sensibility.

  The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

  One hour

• Visual Analogic Scale(0-100) for Tooth Sensibility.

  The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

  Twenty four hours

• Visual Analogic Scale(0-100) for Tooth Sensibility.

  The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility

  Forty eight hours

Study Arms (2)

Experimental

EXPERIMENTAL

35 patients in this group will undergo the whitening procedure using the Dexamethasone acetate intervention.

Drug: Dexamethasone acetate

Placebo

PLACEBO COMPARATOR

35 patients in this group will undergo the whitening procedure using the Potassium Nitrate intervention

Drug: Potassium Nitrate

Interventions

Dexamethasone acetate DRUG

The volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .

Also known as: Dexamethasone

Experimental

Potassium Nitrate DRUG

The volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch \[50%\], lactose monohydrate \[35%\], dibasic calcium phosphate \[14%\], and magnesium stearate \[1%\]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .

Also known as: Smoothe SDI

Placebo

Eligibility Criteria

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

You may qualify if:

• The selected volunteers should present a good general state of health, be at least 18 years of age, regardless of gender, color / race and ethnicity, sexual orientation, and gender identity.
• Volunteers must have an acceptable oral hygiene, present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
• These elements have to be healthy, that is, not having any kind of restoration.
• Volunteers must sign the consent form and clarification, have committed to return for periodic examinations and belong to the group of nonsmokers.

You may not qualify if:

• Do not have medical history of diseases that can affect the results of the study;
• subjects could not have made use of cigarettes in the last 30 days; have some important pathology in the oral cavity;
• not being pregnant and also are not breastfeeding;
• having any history of sensitivity or adverse reactions to anti-inflammatory used in the study;
• not having calculations or advanced periodontal disease;
• have not consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
• The volunteers should not have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product and not present recession or exacerbated hypersensitivity history.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Related Publications (19)

• Carey CM. Tooth whitening: what we now know. J Evid Based Dent Pract. 2014 Jun;14 Suppl:70-6. doi: 10.1016/j.jebdp.2014.02.006. Epub 2014 Feb 13.

  PMID: 24929591 BACKGROUND

• 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 BACKGROUND

• de Paula EA, Kossatz S, Fernandes D, Loguercio AD, Reis A. Administration of ascorbic acid to prevent bleaching-induced tooth sensitivity: a randomized triple-blind clinical trial. Oper Dent. 2014 Mar-Apr;39(2):128-35. doi: 10.2341/12-483-C. Epub 2013 Jun 26.

  PMID: 23802640 BACKGROUND

• de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.

  PMID: 25257824 BACKGROUND

• Bonafe E, Loguercio AD, Reis A, Kossatz S. Effectiveness of a desensitizing agent before in-office tooth bleaching in restored teeth. Clin Oral Investig. 2014 Apr;18(3):839-45. doi: 10.1007/s00784-013-1055-7.

  PMID: 23959376 BACKGROUND

• Bonafe E, Bacovis CL, Iensen S, Loguercio AD, Reis A, Kossatz S. Tooth sensitivity and efficacy of in-office bleaching in restored teeth. J Dent. 2013 Apr;41(4):363-9. doi: 10.1016/j.jdent.2013.01.007. Epub 2013 Jan 26.

  PMID: 23357647 BACKGROUND

• Faria-E-Silva AL, Nahsan FP, Fernandes MT, Martins-Filho PR. Effect of preventive use of nonsteroidal anti-inflammatory drugs on sensitivity after dental bleaching: a systematic review and meta-analysis. J Am Dent Assoc. 2015 Feb;146(2):87-93.e1. doi: 10.1016/j.adaj.2014.10.007.

  PMID: 25637206 BACKGROUND

• He LB, Shao MY, Tan K, Xu X, Li JY. The effects of light on bleaching and tooth sensitivity during in-office vital bleaching: a systematic review and meta-analysis. J Dent. 2012 Aug;40(8):644-53. doi: 10.1016/j.jdent.2012.04.010. Epub 2012 Apr 21.

  PMID: 22525016 BACKGROUND

• Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.

  PMID: 24872720 BACKGROUND

• Li Y, Greenwall L. Safety issues of tooth whitening using peroxide-based materials. Br Dent J. 2013 Jul;215(1):29-34. doi: 10.1038/sj.bdj.2013.629.

  PMID: 23846062 BACKGROUND

• Markowitz K. Pretty painful: why does tooth bleaching hurt? Med Hypotheses. 2010 May;74(5):835-40. doi: 10.1016/j.mehy.2009.11.044. Epub 2009 Dec 31.

  PMID: 20045265 BACKGROUND

• Costa CA, Riehl H, Kina JF, Sacono NT, Hebling J. Human pulp responses to in-office tooth bleaching. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):e59-64. doi: 10.1016/j.tripleo.2009.12.002.

  PMID: 20303048 BACKGROUND

• Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids--new mechanisms for old drugs. N Engl J Med. 2005 Oct 20;353(16):1711-23. doi: 10.1056/NEJMra050541. No abstract available.

  PMID: 16236742 BACKGROUND

• Bamgbose BO, Akinwande JA, Adeyemo WL, Ladeinde AL, Arotiba GT, Ogunlewe MO. Effects of co-administered dexamethasone and diclofenac potassium on pain, swelling and trismus following third molar surgery. Head Face Med. 2005 Nov 7;1:11. doi: 10.1186/1746-160X-1-11.

  PMID: 16274480 BACKGROUND

• Paula E, Kossatz S, Fernandes D, Loguercio A, Reis A. The effect of perioperative ibuprofen use on tooth sensitivity caused by in-office bleaching. Oper Dent. 2013 Nov-Dec;38(6):601-8. doi: 10.2341/12-107-C. Epub 2013 Apr 15.

  PMID: 23586657 BACKGROUND

• Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent. 2011 Nov-Dec;36(6):590-6. doi: 10.2341/10-173-C. Epub 2011 Sep 13.

  PMID: 21913864 BACKGROUND

• 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 BACKGROUND

• Rezende M, Bonafe E, Vochikovski L, Farago PV, Loguercio AD, Reis A, Kossatz S. Pre- and postoperative dexamethasone does not reduce bleaching-induced tooth sensitivity: A randomized, triple-masked clinical trial. J Am Dent Assoc. 2016 Jan;147(1):41-9. doi: 10.1016/j.adaj.2015.07.003. Epub 2015 Nov 6.

  PMID: 26562735 BACKGROUND

• da Costa Poubel LA, de Gouvea CVD, Calazans FS, Dip EC, Alves WV, Marins SS, Barcelos R, Barceleiro MO. Pre-operative use of dexamethasone does not reduce incidence or intensity of bleaching-induced tooth sensitivity. A triple-blind, parallel-design, randomized clinical trial. Clin Oral Investig. 2019 Jan;23(1):435-444. doi: 10.1007/s00784-018-2452-8. Epub 2018 Apr 25.

  PMID: 29696420 DERIVED

MeSH Terms

Conditions

Inflammation; Dentin Sensitivity

Interventions

dexamethasone acetate; Dexamethasone; potassium nitrate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

No discontinuity in both treatment groups was found in the clinical investigation. All volunteers attended the recall visit 1 week postbleaching.

Results Point of Contact

• Title: Dr. Luiz Augusto Poubel
• Organization: Universidade Federal Fluminense

luizpoubel@id.uff.br

55 21 981113344

Study Officials

• Marcos O Barceleiro, MSD, PhD

  Fluminense Federal University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 4, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 25, 2020
• Results First Posted: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share