NCT06345092

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

March 26, 2024

Last Update Submit

November 7, 2024

Conditions

TMJ Pain

Outcome Measures

Primary Outcomes (1)

  • Pain management

    Evaluation of pain using VAS pre and post injections

    at 4;8;12;16 weeks

Secondary Outcomes (1)

  • disc position using MRI

    at 4;8;12;16 weeks

Other Outcomes (2)

  • maximum mouth opening

    at 4;8;12;16 weeks

  • lateral excursion

    at 4;8;12;16 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

injection of injectable platelet rich fibrin with vitamin C

Drug: Vitamin COther: Injectable platelet rich fibrin

control group

ACTIVE COMPARATOR

injection of injectable platelet rich fibrin alone

Other: Injectable platelet rich fibrin

Interventions

Vitamin CDRUG

addition of vitamin C to IPRF

Also known as: Ascorbic acid
intervention group
Injectable platelet rich fibrinOTHER

injection of IPRF alone

Also known as: IPRF
control groupintervention group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pathological conditions ; trauma TMJ cases or any blood diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry cairo university

Cairo, +2, Egypt

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc degree of oral and maxillofacial surgery Cairo University

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 3, 2024

Study Start

April 15, 2024

Primary Completion

May 15, 2024

Study Completion

August 15, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations

EG(1)