NAC Prevents Toxicity of Teeth Bleaching

NAC Prevents Side-Effects of Teeth Bleaching

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.

Study Overview

• Status: Completed
• Conditions: Removal of Toxicity From Dental Bleaching
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: NAC

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Dietary supplement: Placebo; Placebo
Experimental: Experimental Arm; solution containing NAC with buffers	Dietary supplement: NAC; solution containing NAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2014
• Primary Completion (Actual): October 26, 2017
• Study Completion (Actual): October 26, 2017

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: bleaching, toxicity, NAC
• Other Study ID Numbers: 14-001368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No