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The effect of Anaheal medication on pain reduction in patients with temporomandibular joint osteoarthritis.

The effect of Anaheal administration on pain reduction in TMJ osteoarthritis patients; A double blind randomized clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241021063454N1
Enrollment
44
Registered
2025-02-20
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular joint osteoarthritis. Temporomandibular joint disorders

Interventions

Intervention 1: Intervention group: Taking Anaheal (Bromelain) 500 mg three times a day for 7 days. Intervention 2: Control group: Patients treated with diclofenac sodium tablets 50 mg for 7 days.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose osteoarthritis diagnosis has been confirmed by a specialist, based on the patient's history, clinical features, radiographic findings, the onset of symptoms, and bone changes. Patient History: The patient typically complains of unilateral joint pain that worsens with jaw movement. The pain is usually persistent and may intensify in the afternoon or at night. The presence of secondary symptoms, such as central nervous system sensitization, may be observed, manifesting as chronic pain and increased sensitivity to pain. Clinical features: Limitation in jaw opening due to joint pain, a sense of "crepitation" (crackling sound) in the joint, particularly in cases where the condition has been present for a prolonged period, increased pain with pressure on the joint area, and manual loading on the joint. Radiography: The diagnosis is typically confirmed through CBCT imaging of the temporomandibular joint, which reveals structural changes in the subchondral bone (such as flattening, osteophytes, and erosions). Symptom onset: The patient may have symptoms for an extended period (up to 6 months) before sufficient structural changes in the bone are evident on radiographic imaging.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: Before the intervention and on days 5, 7 and 14 after the intervention. Method of measurement: Visual analog scale.;Mouth opening rate. Timepoint: Before the intervention and on days 5, 7 and 14 after the intervention. Method of measurement: Mouth opening is reported in millimeters between the upper and lower incisors.

Secondary

MeasureTime frame
Jaw deviation. Timepoint: Before the intervention and on days 5, 7 and 14 after the intervention. Method of measurement: Present or absent, jaw deviation is diagnosed by clinical examination when the mouth is closing.;Temporomandibular joint sounds. Timepoint: Before the intervention and on days 5, 7 and 14 after the intervention. Method of measurement: ypes of Temporomandibular joint sounds include clicking, popping, and crepitation. Joint sounds are assessed by the presence or absence of these sounds. These sounds are measured by clinical examination during opening and closing or when the joint is pressed.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactnavid kazemian baghan

Mashhad University of Medical Sciences

navid.kazemian87@gmail.com+98 51 3882 9501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026