NAC Prevents Toxicity of Teeth Bleaching

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-04

Study Completion Date

2017-10-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Removal of Toxicity From Dental Bleaching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Experimental Arm

solution containing NAC with buffers

Group Type EXPERIMENTAL

NAC

Intervention Type DIETARY_SUPPLEMENT

solution containing NAC

Interventions

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NAC

solution containing NAC

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes