Arthrocentesis Followed by Prolotherapy

December 27, 2019 updated by: Atef Fouda, Cairo University

TMJ Lavage Followed by Dextrose Prolotherapy

we will do tmj joint lavage and followed by dextrose injection

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 36 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • tmj painful joints patients healthy patients disk displacement with reduction

Exclusion Criteria:

  • patients previously treated males young age group

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: group 1
lavage by dextrose
Other: joint lavage with dextrose
joint lavage with dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: 3 months
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
Time Frame: 3 months
Change in mouth opening- decrease =worse
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Atef Abd El H Fouda, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 8, 2020

Primary Completion (ANTICIPATED)

March 31, 2020

Study Completion (ANTICIPATED)

April 30, 2020

Study Registration Dates

First Submitted

December 15, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (ACTUAL)

December 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cairo University-11022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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