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NAC Prevents Toxicity of Teeth Bleaching

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Completed
Early Phase 1

Conditions

Removal of Toxicity From Dental Bleaching

Treatments

Dietary Supplement: Placebo
Dietary Supplement: NAC

Study type

Interventional

Funder types

Other

Identifiers

NCT03534115
14-001368

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

41 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo was prepared by using the same solution containing buffers that were used in the preparation of NAC solution, except it did not contain NAC
Treatment:
Dietary Supplement: Placebo
Experimental Arm
Experimental group
Description:
solution containing NAC with buffers
Treatment:
Dietary Supplement: NAC

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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