An Early Phase 1 interventional study of NAC and Placebo in Removal of Toxicity From Dental Bleaching, sponsored by University of California, Los Angeles. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Prevention
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.
University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
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
solution containing NAC with buffers
Dietary Supplement: NAC
solution containing NAC
Placebo
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.
Time frame: 3 weeks
white lesion in gingiva
number and extend of white lesions in gingiva
Time frame: 3 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles