NAC Prevents Toxicity of Teeth Bleaching | NCT03534115

Studies
NAC Prevents Toxicity of Teeth Bleaching

NCT03534115

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

May 23, 2018Actual

Enrollment

41Actual

Phase

Early Phase 1

Conditions

Removal of Toxicity From Dental Bleaching

Interventions

NAC
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2014Actual

Primary Completion Date

Oct 26, 2017Actual

Completion Date

Oct 26, 2017Actual

First Submitted Date

May 11, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

May 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2018

Last Update Posted Date

May 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anahid Jewett, Principal Investigator, University of California, Los AngelesPrincipal Investigator

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NAC	Dietary Supplement	solution containing NAC	Experimental Arm
Placebo

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
white lesion in gingiva	number and extend of white lesions in gingiva	3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided