Arthrocentesis Followed by Prolotherapy

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04212975
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Anticipated Duration (Months): 3.7

Study Details

Study Description

Brief Summary

we will do tmj joint lavage and followed by dextrose injection

Condition or Disease	Intervention/Treatment	Phase
TMJ Pain	Other: joint lavage with dextrose	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Masking Description: assessment of improvement
• Primary Purpose: Treatment
• Official Title: TMJ Lavage Followed by Dextrose Prolotherapy
• Anticipated Study Start Date: Jan 8, 2020
• Anticipated Primary Completion Date: Mar 31, 2020
• Anticipated Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 lavage by dextrose	Other: joint lavage with dextrose; joint lavage with dextrose

Outcome Measures

Primary Outcome Measures

1. pain scores [3 months]

   Change in pain symptoms measured by visual analogue scale 1=better-to-10 worse

2. Maximum mouth opening measured in millimeter 36mm=normal, less than 36mm=worse [3 months]

   Change in mouth opening- decrease =worse

Secondary Outcome Measures

1. Change in pain symptoms measured by visual analogue scale [3 months]

   Measurement of change in pain scores from 1-10, 1=better-to-10 worse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 36 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• tmj painful joints patients healthy patients disk displacement with reduction

Exclusion Criteria:

• patients previously treated males young age group

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Atef Fouda, clinical professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04212975
• Other Study ID Numbers: Cairo University-11022
• First Posted: Dec 30, 2019
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Atef Fouda, clinical professor, Cairo University: tmj; pain

Study Results

No Results Posted as of Jan 2, 2020