NAC Prevents Toxicity of Teeth Bleaching

Study Overview
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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.

Official Title
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NAC Prevents Side-Effects of Teeth Bleaching

Conditions
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Removal of Toxicity From Dental Bleaching

Intervention / Treatment
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* Dietary Supplement: NAC
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Placebo<br>|
| Experimental: Experimental Arm<br>solution containing NAC with buffers | Dietary Supplement: NAC<br>* solution containing NAC<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleaching, toxicity, NAC