NAC Prevents Toxicity of Teeth Bleaching

NCT03534115 | Completed Early Phase 1

• 1 other identifier: 14-001368
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Removal of Toxicity From Dental Bleaching

Keywords

bleaching, toxicity, NAC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• white lesion in gingiva

  3 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Experimental Arm

EXPERIMENTAL

solution containing NAC with buffers

Dietary Supplement: NAC

Interventions

NAC DIETARY_SUPPLEMENT

solution containing NAC

Experimental Arm

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the investigators, clinical staff and patients were blinded. The main solution containing NAC or the placebo was marked by A and B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: December 4, 2014
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share