Health TrialsbyHealthPanel

Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management

ConditionTMJ Disc Displacement With Reduction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMansoura University

About this trial

The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 45 years.

Patients with disc displacement with reduction in any of the TMJs.

arthralgia.

Limited unassisted mouth opening.

Disqualifiers

Patients with previous history of TMJ minimally invasive interventions.

Patients with autoimmune or connective tissue diseases affecting the joints.

Patients with neurological disorders.

Patients with a history of condylar fractures or ankylosis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution

    Procedure/Surgery

    18 joints that receive arthrocentesis using 100 ml of ringer lactate solution

  • Arthrocentesis followed by hyaluronic acid injection

    Procedure/Surgery

    18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid

  • Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture

    Procedure/Surgery

    18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture

  • Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture

    Procedure/Surgery

    18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: Group I: Arthrocentesis onlyActive comparator 1 intervention
Group B: Group II: Arthrocentesis followed by hyaluronic acid injectionActive comparator 1 intervention
Group C: Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixtureActive comparator 1 intervention
Group D: Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixtureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of pain

Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever

Time frame
preoperative, one week, one month, 3 months and 6 months
2

Maximum interincisal opening, lateral and protrusive movements

1. Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper. 2. Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.

Time frame
preoperative, one week, one month, 3 months and 6 months

Secondary outcomes

1

Clicking

clicking will be evaluated as either present or absent throughout the follow up intervals

Time frame
preoperative, one week, one month, 3 months and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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