Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain

April 2, 2024 updated by: Youmna alaa yehia, Cairo University

Comparison Between Injectable Platelet Rich Fibrin With Vitamin C and Injectable Platelet Rich Fibrin Alone in Management of ID'Pain

Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement

Study Type

Interventional

Enrollment (Actual)

40

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.

Study Locations

  • Egypt
      • Cairo, Egypt, +2
        • Faculty of dentistry cairo university

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with internal TMJ derangement (anterior disc displacement with reduction)

Exclusion Criteria:

Pathological conditions ; trauma TMJ cases or any blood diseases

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
injection of injectable platelet rich fibrin with vitamin C
Drug: Vitamin C
addition of vitamin C to injectable platelet rich fibrin
Other Names:
  • Ascorbic acid
Other: Injectable platelet rich fibrin
Injectable platelet rich fibrin
Other Names:
  • IPRF
Active Comparator: control group
injection of injectable platelet rich fibrin alone
Other: Injectable platelet rich fibrin
Injectable platelet rich fibrin
Other Names:
  • IPRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain management
Time Frame: at 4;8;12;16 weeks
Evaluation of pain using VAS pre and post injections
at 4;8;12;16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disc position using MRI
Time Frame: at 4;8;12;16 weeks
evaluation of disc position pre and post injections
at 4;8;12;16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum mouth opening
Time Frame: at 4;8;12;16 weeks
measurement of MMO using digital caliper pre and post injections
at 4;8;12;16 weeks
lateral excursion
Time Frame: at 4;8;12;16 weeks
measurement of lateral excursion using digital caliper pre and post injections
at 4;8;12;16 weeks

Collaborators and Investigators

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

Sponsor

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 (Actual)

September 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Omfs.3-3-3

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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