Arthrocentesis Followed by Prolotherapy | NCT04212975

Studies
Arthrocentesis Followed by Prolotherapy

NCT04212975

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 2, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

TMJ Pain

Interventions

joint lavage with dextrose

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2020Estimated

Primary Completion Date

Mar 31, 2020Estimated

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Dec 15, 2019

First Submission Date that Met QC Criteria

Dec 25, 2019

First Posted Date

Dec 30, 2019Actual

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

Dec 27, 2019

Last Update Posted Date

Jan 2, 2020Actual

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

we will do tmj joint lavage and followed by dextrose injection

Detailed Description

Two groups of patients one group will receive lavage with saline and other group will receive lavage then dextrose injection

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Experimental	lavage by dextrose	Other: joint lavage with dextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
joint lavage with dextrose	Other	joint lavage with dextrose	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain scores	Change in pain symptoms measured by visual analogue scale 1=better-to-10 worse	3 months
Maximum mouth opening measured in millimeter 36mm=normal, less than 36mm=worse	Change in mouth opening- decrease =worse	3 months

Secondary Outcomes

Measure	Description	Time Frame
Change in pain symptoms measured by visual analogue scale	Measurement of change in pain scores from 1-10, 1=better-to-10 worse	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

tmj painful joints patients healthy patients disk displacement with reduction

Exclusion Criteria:

patients previously treated males young age group

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Atef Abd El H Fouda	Contact	+201093440600		atef.fouda@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Atef Abd El H Fouda	Cairo University	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders
D010146	Pain

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided