NAC Prevents Toxicity of Teeth Bleaching

NAC Prevents Side-Effects of Teeth Bleaching

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03534115

Enrollment

Registered

2018-05-23

Start date

2014-12-04

Completion date

2017-10-26

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Removal of Toxicity From Dental Bleaching

Keywords

bleaching, toxicity, NAC

Brief 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.

Interventions

DIETARY_SUPPLEMENTNAC

solution containing NAC

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

the investigators, clinical staff and patients were blinded. The main solution containing NAC or the placebo was marked by A and B.

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
inhibition of pain	3 weeks	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.

Secondary

Measure	Time frame	Description
white lesion in gingiva	3 weeks	number and extend of white lesions in gingiva

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026