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NAC Prevents Toxicity of Teeth Bleaching

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ClinicalTrials.gov Identifier: NCT03534115
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Anahid Jewett, 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.

Condition or disease Intervention/treatment Phase
Removal of Toxicity From Dental Bleaching Dietary Supplement: NAC Dietary Supplement: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: the investigators, clinical staff and patients were blinded. The main solution containing NAC or the placebo was marked by A and B.
Primary Purpose: Prevention
Official Title: NAC Prevents Side-Effects of Teeth Bleaching
Actual Study Start Date : December 4, 2014
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

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




Primary Outcome Measures :
  1. inhibition of pain [ Time Frame: 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 :
  1. white lesion in gingiva [ Time Frame: 3 weeks ]
    number and extend of white lesions in gingiva



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Anahid Jewett, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03534115     History of Changes
Other Study ID Numbers: 14-001368
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anahid Jewett, University of California, Los Angeles:
bleaching, toxicity, NAC