Clinical Evaluation for Post Bleaching Hypersensitivity U... | NCT02942082

Studies
Clinical Evaluation for Post Bleaching Hypersensitivity Using Desensitizing Agent During In-office Bleaching

NCT02942082

Sponsor

Cairo University

Status

Completed

Last Update Posted

Sep 18, 2019Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Tooth Bleaching

Interventions

ACP oral care gel
glycrin

Countries

Egypt

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

Sep 2019

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

Nov 1, 2017Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Nov 29, 2018Actual

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Oct 20, 2016

First Posted Date

Oct 21, 2016Estimated

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 16, 2019

Last Update Posted Date

Sep 18, 2019Actual

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

Evaluating the effect of a desensitizing agent on post-bleaching hypersensitivity.

Detailed Description

A randomized clinical trail will be done to evaluate the effect of a desensitizing agent ACP oral care gel in comparison to a control group on hypersensitivity after bleaching using a visual analogue scale.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACP oral care geldesensitizing agent	Experimental	a desensitizing agent will be applied on tooth before and /or after bleaching.	Other: ACP oral care gel
glycrin	Placebo Comparator	glycrin will be applied on tooth before and /or after bleaching.	Other: glycrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACP oral care gel	Other	a desensitizing agent will be applied on tooth before and/or after bleaching	ACP oral care geldesensitizing agent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-bleaching hypersensitivity assessed using visual analogue scale	using visual analogue scale	one month

Secondary Outcomes

Measure	Description	Time Frame
Tooth color assessed using value-ordered VITA® Classical Shade Guide	value-ordered VITA® Classical Shade Guide	one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must show no signs of spontaneous dental pain.
Male or female patients between the ages of 18 to 40.
Patients with good general and oral health.
Patients having six caries-free maxillaryanterior teeth without restorations on the labial surfaces.
Patients should have central incisors determined to be shade C2 or darker

Exclusion Criteria:

Patient with spontaneous dental pain.
Patient with anterior restorations or non carious cervical lesion.
Patient having severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth), and bruxism habits.
Tempro-mandibular joint problems involving symptomatic pain.
Patients taking analgesics that could alter their normal pain perception level.
Pregnant or breast feeding women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry Cairo university		Cairo		11651	Egypt

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