The Correlation and Relationship Between Chromaticity Par... | NCT03153605

Studies
The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching

NCT03153605

Sponsor

Fujian Medical University

Status

Unknown status

Last Update Posted

Sep 29, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Bleaching; Satisfactory

Interventions

Common toothpaste

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Oct 9, 2017Estimated

Completion Date

Dec 9, 2017Estimated

First Submitted Date

Apr 24, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 15, 2017Actual

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

Sep 27, 2017

Last Update Posted Date

Sep 29, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hao Yu, Deputy Director, Department of Scientific Research, Fujian Medical UniversityPrincipal Investigator

Lead Sponsor

Fujian Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SATISI_7	Experimental		Other: Common toothpaste

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Common toothpaste	Other	different toothpaste	SATISI_7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of tooth color	The certain points of tooth color	baseline, 7 days after treatment, 14 days after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age around 20~28 years,
at least six anterior teeth without restorations,
good general and oral health (no dental caries and periodontal disease).

Exclusion Criteria:

tooth sensitivity,
any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure),
participants under orthodontic treatment,
smokers.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

28 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided