NAC Prevents Toxicity of Teeth Bleaching

Early Phase 1

Completed

• Conditions: Removal of Toxicity From Dental Bleaching
• Interventions: Dietary Supplement: NAC; Dietary Supplement: Placebo

• Registration Number: NCT03534115
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-04
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Subjects will be self reported as healthy individuals with no significant medical issues.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	NAC	solution containing NAC with buffers
Placebo	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
white lesion in gingiva	3 weeks	number and extend of white lesions in gingiva