Effect of Glutaraldehyde-based Desensitizer in the Control of Tooth Sensitivity and Tooth Color Post- Whitening

NCT05309967 | Completed

• 1 other identifier: UFpara-0012
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth whitening is one of the most indicated aesthetic procedures in dentistry and there is evidence that it interferes with aspects of patients' quality of life. However, the sensitivity, associated with the post-procedure period, challenges clinicians and researchers. The use of topic desensitizing agents could be a alternative for the control of this adverse effects of bleaching agents. The objective of this randomized clinical study, therefore, is to evaluate the effect of glutaraldehyde-based desensitizing agent associated on tooth sensitivity and tooth color after bleaching with 35% hydrogen peroxide. 25 patients will be selected divided into two groups for a double-blind and split-mouth study. Among the results it is expected: that the use of glutaraldehyde desensitizing agent helps in the control of post-bleaching sensitivity, without harming the final color obtained of patients submitted to the proposed clinical protocol.

Conditions

Dentin Sensitivity

Keywords

Tooth Bleaching; dentin adhesives; tooth sensitivity

Outcome Measures

Primary Outcomes (2)

• Use of glutaraldehyde based material with or without low level laser therapy in tooth sensitivity during whitening protocol with 35 % hydrogen peroxide.

  Self-reported pain intensity will be assessed daily, during 21 days, through self-perception questionnaire, answered by the patients from the first tooth bleaching session until one week after the last session. The evaluation will be performed by each patient, according to a numeric visual analog scale, as follows: 0 - 10. Where 0 correspond to no pain and 10 the most severe pain that patient have been ever identified

  Patients will be evaluated during 21 days.

• Use of glutaraldehyde based material with or without low level laser therapy in patient´s quality of life after whitening protocol with 35 % hydrogen peroxide.

  A questionnaire will be applied before the bleaching treatment, after the completion of the bleaching treatment and 6 months after bleaching as a follow up

  6 months

Study Arms (2)

GLUMA

EXPERIMENTAL

Glutaraldehyde + Hydroxyethyl methacrylate (GLUMA® Desensitizer)

Other: GLUMA DESINSITIZER

PLACEBO

PLACEBO COMPARATOR

DISTILLED WATER

Other: PLACEBO

Interventions

GLUMA DESINSITIZER OTHER

GLUTARALDEHYDE

GLUMA

PLACEBO OTHER

DESTILLED WATER

PLACEBO

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy incisors, canines and premolars;
• Do not having a diagnosis of dental hypersensitivity.
• Do not have been at desensitizing treatment in the past two years.
• Do not have been done dental whitening treatment.

You may not qualify if:

• Patients undergoing orthodontic treatment;
• Presence of periodontal disease;
• Presence of cracks or fractures in the teeth
• Presence of restorations and prostheses in anterior teeth;
• Presence of extensive restorations and/or deep in molars;
• Patients with serious dental darkening internal or external ;
• Presence of exposed dentin.
• Pregnant and lactating women.
• Patients on active treatment whom are using anti-inflammatory drugs and painkillers.

Sponsors & Collaborators

• Universidade Federal do Para: lead

Study Sites (1)

Raissa Araujo de Mesquita

Belém, Pará, 66087680, Brazil

Location

Related Publications (20)

• de Paula B, Alencar C, Ortiz M, Couto R, Araujo J, Silva C. Effect of photobiomodulation with low-level laser therapy combined with potassium nitrate on controlling post-bleaching tooth sensitivity: clinical, randomized, controlled, double-blind, and split-mouth study. Clin Oral Investig. 2019 Jun;23(6):2723-2732. doi: 10.1007/s00784-018-2715-4. Epub 2018 Oct 25.

  PMID: 30361793 BACKGROUND

• Shulman JD, Maupome G, Clark DC, Levy SM. Perceptions of desirable tooth color among parents, dentists and children. J Am Dent Assoc. 2004 May;135(5):595-604; quiz 654-5. doi: 10.14219/jada.archive.2004.0247.

  PMID: 15202751 BACKGROUND

• Alkhatib MN, Holt R, Bedi R. Prevalence of self-assessed tooth discolouration in the United Kingdom. J Dent. 2004 Sep;32(7):561-6. doi: 10.1016/j.jdent.2004.06.002.

  PMID: 15386863 BACKGROUND

• Rezende M, Loguercio AD, Kossatz S, Reis A. Predictive factors on the efficacy and risk/intensity of tooth sensitivity of dental bleaching: A multi regression and logistic analysis. J Dent. 2016 Feb;45:1-6. doi: 10.1016/j.jdent.2015.11.003. Epub 2015 Dec 2.

  PMID: 26612623 BACKGROUND

• Kwon SR, Wertz PW. Review of the Mechanism of Tooth Whitening. J Esthet Restor Dent. 2015 Sep-Oct;27(5):240-57. doi: 10.1111/jerd.12152. Epub 2015 May 13.

  PMID: 25969131 BACKGROUND

• Cardenas AFM, Maran BM, Araujo LCR, de Siqueira FSF, Wambier LM, Gonzaga CC, Loguercio AD, Reis A. Are combined bleaching techniques better than their sole application? A systematic review and meta-analysis. Clin Oral Investig. 2019 Oct;23(10):3673-3689. doi: 10.1007/s00784-019-03042-4. Epub 2019 Aug 29.

  PMID: 31468261 BACKGROUND

• Kwon SR, Dawson DV, Schenck DM, Fiegel J, Wertz PW. Spectrophotometric Evaluation of Potassium Nitrate Penetration Into the Pulp Cavity. Oper Dent. 2015 Nov-Dec;40(6):614-21. doi: 10.2341/14-214-L. Epub 2015 Jul 7.

  PMID: 26151563 BACKGROUND

• Klaric Sever E, Budimir Z, Cerovac M, Stambuk M, Par M, Negovetic Vranic D, Tarle Z. Clinical and patient reported outcomes of bleaching effectiveness. Acta Odontol Scand. 2018 Jan;76(1):30-38. doi: 10.1080/00016357.2017.1376111. Epub 2017 Sep 11.

  PMID: 28893130 BACKGROUND

• Caviedes-Bucheli J, Ariza-Garcia G, Restrepo-Mendez S, Rios-Osorio N, Lombana N, Munoz HR. The effect of tooth bleaching on substance P expression in human dental pulp. J Endod. 2008 Dec;34(12):1462-5. doi: 10.1016/j.joen.2008.09.013. Epub 2008 Oct 31.

  PMID: 19026874 BACKGROUND

• Vaz MM, Lopes LG, Cardoso PC, Souza JB, Batista AC, Costa NL, Torres EM, Estrela C. Inflammatory response of human dental pulp to at-home and in-office tooth bleaching. J Appl Oral Sci. 2016 Sep-Oct;24(5):509-517. doi: 10.1590/1678-775720160137.

  PMID: 27812622 BACKGROUND

• Marto CM, Baptista Paula A, Nunes T, Pimenta M, Abrantes AM, Pires AS, Laranjo M, Coelho A, Donato H, Botelho MF, Marques Ferreira M, Carrilho E. Evaluation of the efficacy of dentin hypersensitivity treatments-A systematic review and follow-up analysis. J Oral Rehabil. 2019 Oct;46(10):952-990. doi: 10.1111/joor.12842. Epub 2019 Jul 12.

  PMID: 31216069 BACKGROUND

• de Melo Alencar C, Castro da Silva R, Nogueira Araujo JL, Silva da Silveira AD, Martins Silva C. A clinical, randomized, double-blind study on the use of toothpastes immediately after at-home tooth bleaching. Am J Dent. 2017 Oct;30(5):267-271.

  PMID: 29178730 BACKGROUND

• Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.

  PMID: 26964798 BACKGROUND

• Pompeu DDS, de Paula BLF, Barros APO, Nunes SC, Carneiro AMP, Araujo JLN, Silva CM. Combination of strontium chloride and photobiomodulation in the control of tooth sensitivity post-bleaching: A split-mouth randomized clinical trial. PLoS One. 2021 Apr 28;16(4):e0250501. doi: 10.1371/journal.pone.0250501. eCollection 2021.

  PMID: 33909659 BACKGROUND

• Diniz A, Lima S, Tavarez R, Borges AH, Pinto S, Tonetto MR, Loguercio AD, Bandeca MC. Preventive Use of a Resin-based Desensitizer Containing Glutaraldehyde on Tooth Sensitivity Caused by In-office Bleaching: A Randomized, Single-blind Clinical Trial. Oper Dent. 2018 Sep/Oct;43(5):472-481. doi: 10.2341/17-020-C. Epub 2018 Mar 23.

  PMID: 29570018 BACKGROUND

• Lopes AO, de Paula Eduardo C, Aranha ACC. Evaluation of different treatment protocols for dentin hypersensitivity: an 18-month randomized clinical trial. Lasers Med Sci. 2017 Jul;32(5):1023-1030. doi: 10.1007/s10103-017-2203-0. Epub 2017 Apr 8.

  PMID: 28391435 BACKGROUND

• Qin C, Xu J, Zhang Y. Spectroscopic investigation of the function of aqueous 2-hydroxyethylmethacrylate/glutaraldehyde solution as a dentin desensitizer. Eur J Oral Sci. 2006 Aug;114(4):354-9. doi: 10.1111/j.1600-0722.2006.00382.x.

  PMID: 16911108 BACKGROUND

• Parreiras SO, Szesz AL, Coppla FM, Martini EC, Farago PV, Loguercio AD, Reis A. Effect of an experimental desensitizing agent on reduction of bleaching-induced tooth sensitivity: A triple-blind randomized clinical trial. J Am Dent Assoc. 2018 Apr;149(4):281-290. doi: 10.1016/j.adaj.2017.10.025. Epub 2018 Feb 10.

  PMID: 29439773 BACKGROUND

• Wong AH, Cheung CS, McGrath C. Developing a short form of Oral Health Impact Profile (OHIP) for dental aesthetics: OHIP-aesthetic. Community Dent Oral Epidemiol. 2007 Feb;35(1):64-72. doi: 10.1111/j.1600-0528.2007.00330.x.

  PMID: 17244139 BACKGROUND

• Pires CP, Ferraz MB, de Abreu MH. Translation into Brazilian Portuguese, cultural adaptation and validation of the oral health impact profile (OHIP-49). Braz Oral Res. 2006 Jul-Sep;20(3):263-8. doi: 10.1590/s1806-83242006000300015.

  PMID: 17119711 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For the double-blind study, the evaluator and the patient will be blinded. The bleaching procedure and the therapies under study will be performed by one operator and will only involve one evaluator not participant in the randomization and without knowledge of the interventions applied in the groups. The evaluator will be responsible for measuring and tabulating information regarding sensitivity, color analysis and the impact on patients' quality of life. The desensitizer and its placebo will be placed in similar containers so that they cannot be identified by the volunteers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: It is a split mouth study composed of two groups randomized between left and right sides.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 4, 2022
• Study Start: March 13, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 30, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

BR (1)