Pain After Buffered Vs Non Buffered Articaine | NCT06538233

Studies
Pain After Buffered Vs Non Buffered Articaine

NCT06538233

Sponsor

Cleveland Dental Institute

Status

Recruiting

Last Update Posted

Aug 5, 2024Actual

Enrollment

108Estimated

Phase

Phase 2

Conditions

Pain

Interventions

Buffered articaine
Non buffered articaine

Countries

United States

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Jul 17, 2024

First Submission Date that Met QC Criteria

Jul 31, 2024

First Posted Date

Aug 5, 2024Actual

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

Jul 31, 2024

Last Update Posted Date

Aug 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buffered articaine	Experimental		Drug: Buffered articaine
non buffered articaine	Active Comparator		Drug: Non buffered articaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buffered articaine	Drug	Injecting buffered articaine in maxillary anterior region and evaluate pain response.	Buffered articaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical Rate Scale (NRS)	Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain .	Immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females, age- 18 to 60 yrs.
Medically free.
Need a dental treatment in the upper anterior region.

Exclusion Criteria:

Periodontally affected teeth.
Radiographic bone loss.
Upnormal length of the teeth.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pavanpreet Kaur, Resident	Contact	2163551155		p.kaur@cdiohio.org
Jana Aboul-Hassan, Resident	Contact	7262054266		j.aboulhassan@cdiohio.org

Overall Officials

Name	Affiliation	Role
Ahmed H Khalifa, PhD	Cleveland Dental Institute	Study Chair
Waleed Elmallah, PhD	Cleveland Dental Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clevland Dental Institute	Recruiting	Cleveland	Ohio	44128	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided