NAC Prevents Toxicity of Teeth Bleaching

Removal of Toxicity From Dental Bleaching Clinical Trial

Official title:

NAC Prevents Side-Effects of Teeth Bleaching

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534115
• Other study ID #: 14-001368
• Status: Completed
• Phase: Early Phase 1
• Start date: December 4, 2014
• Est. completion date: October 26, 2017

Study information

• Verified date: May 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dental bleaching is a simple procedure for aesthetic restoration of vital and non-vital discolored teeth. Nevertheless, a number of studies conducted previously demonstrated the risk of tissue damage from contact of these agents with the oral mucosa along with their possible genotoxic potential after exposure to oral mucosa. Hence the aim of this study is to conduct a human clinical trial to incorporate the chemoprotectant N-acetyl cysteine (NAC) in the procedure of bleaching which could safely be used to eliminate the toxicity of bleaching materials leaving their esthetic benefits intact. 30-40 human subjects will be recruited and bleaching will be done at the UCLA School of Dentistry dental clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 26, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects will be self reported as healthy individuals with no significant medical issues.

Exclusion Criteria:

• Self-report of present medical history (determined by the primary care doctors) of donors for:

• Pregnancy

• HIV-seropositivity and AIDS because the study is designed to evaluate the effect of NAC in general population with no underlying immunological deficiencies or general pathologies which may result in confounding effect in the outcome. Since this is a small study we are limiting the procedure to healthy individuals with no known underlying pathologies.

Related Conditions & MeSH terms

• Removal of Toxicity From Dental Bleaching

Intervention

Dietary Supplement:
• NAC
solution containing NAC
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inhibition of pain	Patients self report of pain on a 0-10 pain scale with 10 being the highest for mean pain levels and 0-5 pain scale with 5 being the highest for resting pain levels.	3 weeks
Secondary	white lesion in gingiva	number and extend of white lesions in gingiva	3 weeks