Treatment of Dentin Hypersensitivity Using Different Dese... | NCT04340869

Studies
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents

NCT04340869

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Apr 10, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Dentin Sensitivity

Interventions

Theobromine
Remin Pro

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 10, 2020Actual

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

Apr 9, 2020

Last Update Posted Date

Apr 10, 2020Actual

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

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Theobromine	Experimental	Natural extract from Cocoa	Other: Theobromine
Remin Pro	Active Comparator	Fluoride , Hydroxyapatite , and Xylitol	Other: Remin Pro
Combination	Experimental	Remin Pro and Theobromine	Other: Theobromine Other: Remin Pro

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Theobromine	Other	Natural extract from Cocoa	Combination Theobromine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue scale pain score	0 = no pain to 10=severe exagerated pain	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients that aged 18-50 years.
Patients in good general health.
Patients that have accessible teeth demonstrating signs of sensitivity.

Exclusion Criteria:

• Any chronic debilitating disease that could influence study outcomes.
- Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.
- Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.
- Desensitising treatment or tooth bleaching within 8 weeks of screening.
- Daily use of medications that might influence the perception of pain.(

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ebtsam Kassab	Contact	+201005889938		dentiebtsamkassab@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar University , Faculty of Dental medicine for Girls	Recruiting	Cairo		11111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003807	Dentin Sensitivity

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013805	Theobromine

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided