Hypersensitivity and Color Changes of Bleached Teeth Using Different Remineralizing Agents

NCT04875000 | Completed

• 1 other identifier: 2433042021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this in vivo study is to evaluate the post-bleaching enamel hypersensitivity and the possible color changes following the application of arginine and nano-hydroxyapatite remineralizing solutions after enamel bleaching using an in-office chemical bleaching agent. A commercial Fluoride remineralizing and desensitizing agent will be used as the control group. Following bleaching of the anterior teeth and then the application of the different tested remineralizing agents; the patients will be assessed for post-bleaching hypersensitivity using the visual analogue scale (VAS) to describe the severity of the hypersensitivity from mild to moderate to severe. On the other hand, the baseline shade and post-bleaching color changes will be evaluated using a shade guide. The data will be collected and tabulated then the statistical analysis will be performed. The null hypothesis is that the different tested remineralizing agents will have a similar effect on the post-bleaching teeth hypersensitivity \& the color changes of the bleached teeth.

Conditions

Tooth Hypersensitivity

Keywords

Teeth bleaching; Remineralizing agents; Arginine solution; Nano-hydroxyapatite solution; Hypersensitivity; Color changes

Outcome Measures

Primary Outcomes (1)

• Teeth Hypersensitivity change

  Evaluation of the change in the pre- and post-bleaching teeth hypersensitivity using the Visual Analogue Scale method (VAS) to describe the severity of the hypersensitivity from mild to moderate to severe. Whereby, readings from 0-10. Zero denoting no sensitivity, 1-3 is presented as mild, 4-7 is presented as moderate and 8-10 is presented as severe sensitivity by the description of each one of the participants using a printed chart.

  Baseline to 3-week follow up period.

Secondary Outcomes (1)

• Color change

  Baseline to 3-week follow up period.

Study Arms (3)

UltraEZ

ACTIVE COMPARATOR

Group of patients randomly assigned to receive the the application of the commercial fluoride remineralizing and desensitizing agent "UltraEZ (Ultradent Products, Inc, South Jordan, UT, USA)" after teeth bleaching

Other: Remineralizing agent I application

Arginine

EXPERIMENTAL

Group of patients randomly assigned to receive the the application of the 2.5% arginine solution after teeth bleaching

Other: Remineralizing agent II application

Nano-hydroxyapatite

EXPERIMENTAL

Group of patients randomly assigned to receive the application of the 2.5% nano-hydroxyapatite solution after teeth bleaching

Other: Remineralizing agent III application

Interventions

Remineralizing agent I application OTHER

Application of UltraEZ remineralizing agent to the bleached teeth

UltraEZ

Remineralizing agent II application OTHER

Application of 2.5% arginine solution to the bleached teeth

Arginine

Remineralizing agent III application OTHER

Application of 2.5% nano-hydroxyapatite solution to the bleached teeth

Nano-hydroxyapatite

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants of 18-55 years old
• Participants with good general and oral health.
• Participants did not undergo any bleaching procedure before.
• Participants with caries-free maxillary six anterior teeth without any restorations.
• Participants do not suffer of periodontal diseases.
• Participants willing to assess and sign the informed consent form.

You may not qualify if:

• Participants with anterior restorations.
• Participants with dental prosthesis of the anterior teeth.
• Participants with orthodontics brackets.
• Participants with severe internal teeth discoloration as in cases of tetracycline stains, fluorosis or non-vital teeth.
• Smoking participants.
• Breastfeeding and pregnant women.
• Participants with gingival and bone recession.
• Participants with dental erosion, dentin exposure, and cracked teeth or any other pathologic condition that may elicit teeth sensitivity.
• Participants having their teeth bleached.
• Participants taking analgesic or anti-inflammatory drugs.
• Participants with bruxism habits are excluded from the study.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Giza Governorate, 12622, Egypt

Location

Related Publications (5)

• Soares DG, Basso FG, Pontes EC, Garcia Lda F, Hebling J, de Souza Costa CA. Effective tooth-bleaching protocols capable of reducing H(2)O(2) diffusion through enamel and dentine. J Dent. 2014 Mar;42(3):351-8. doi: 10.1016/j.jdent.2013.09.001. Epub 2013 Sep 19.

  PMID: 24056046 BACKGROUND

• Browning WD, Chan DC, Myers ML, Brackett WW, Brackett MG, Pashley DH. Comparison of traditional and low sensitivity whiteners. Oper Dent. 2008 Jul-Aug;33(4):379-85. doi: 10.2341/07-134.

  PMID: 18666494 BACKGROUND

• Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.

  PMID: 20884923 BACKGROUND

• Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6.

  PMID: 26159384 BACKGROUND

• Borges BC, Borges JS, de Melo CD, Pinheiro IV, Santos AJ, Braz R, Montes MA. Efficacy of a novel at-home bleaching technique with carbamide peroxides modified by CPP-ACP and its effect on the microhardness of bleached enamel. Oper Dent. 2011 Sep-Oct;36(5):521-8. doi: 10.2341/11-013-L. Epub 2011 Aug 5.

  PMID: 21819199 BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Lamiaa M Moharam, Ass. Prof

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: None of the participants is aware of the remineralizing agent to be applied to his/her teeth after bleaching
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel interventional study model

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 6, 2021
• Study Start: March 20, 2021
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-04

Locations

EG (1)