- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07571265
Intra-articular Injection for the Relief of Temporomandibular Joint Pain
A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.
The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.
The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.
Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.
In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Cairo Governorate
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Al Manyal, Cairo Governorate, Egypten, 11553
- Faculty of Dentistry
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
- 2. Age ≥ 18 years < 50
Exclusion Criteria:
- 1. Previous TMJ surgery
- 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
- 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
- 4. pregnant women or breastfeeding ones
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: platelet rich plasma(PRP)
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Aktiv komparator: triamcinolone acetonide
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Aktiv komparator: hyaluronic acid
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Placebo-jämförare: saline(placebo)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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pain intensity
Tidsram: preoperative as baseline then after one week, 1 month, 3 months and 6 months
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The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
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preoperative as baseline then after one week, 1 month, 3 months and 6 months
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pain-free mouth opening
Tidsram: preoperative as baseline then after one week, 1 month, 3 months and 6 months
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The maximum mouth opening measured with a caliper in millimeters.
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preoperative as baseline then after one week, 1 month, 3 months and 6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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crepitus sounds
Tidsram: preoperative as baseline then after one week, 1 month, 3 months and 6 months
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asking the patient at every appointment
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preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mohamed MA el saadany, master, mohamed_mostafa@dentistry.cu.edu.eg
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Intra articular injections
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