NCT04212975

Brief Summary

we will do tmj joint lavage and followed by dextrose injection

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

December 15, 2019

Last Update Submit

December 27, 2019

Conditions

Keywords

tmjpain

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Change in pain symptoms measured by visual analogue scale

    3 months

Study Arms (1)

group 1

EXPERIMENTAL

lavage by dextrose

Other: joint lavage with dextrose

Interventions

joint lavage with dextrose

group 1

Eligibility Criteria

Age19 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • tmj painful joints patients healthy patients disk displacement with reduction

You may not qualify if:

  • patients previously treated males young age group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Atef Abd El H Fouda

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Masking Details
assessment of improvement
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 30, 2019

Study Start

January 8, 2020

Primary Completion

March 31, 2020

Study Completion

April 30, 2020

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share