Investigating the effect of anaheal plus on pain reduction process in people with Temporomandibular disorder: a double-blinded clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250501065554N1

Enrollment

360

Registered

2025-05-10

Start date

2025-05-11

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Temporomandibular Disorder (TMD) refers to a group of musculoskeletal conditions affecting the temporomandibular joint (TMJ) and surrounding muscles. Common symptoms include facial pain, restricted jaw movement, joint sounds during jaw movements, headaches, and difficulties with chewing, speaking, and swallowing. TMD is a multifactorial condition influenced by biological, environmental, psychological, and cognitive factors. It can significantly affect a patient's quality of life and may require

Interventions

Intervention 1: The intervention group will receive Anaheal Plus, an oral supplement containing bromelain and turmeric. Each participant in this group will take two capsules daily for 15 days. The gro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients requiring TMD treatment based on the diagnosis of a maxillofacial surgeon

Exclusion criteria

Exclusion criteria: Allergy to turmeric

Design outcomes

Primary

Measure	Time frame
Pain: Measured by the means of a thorough examination and history taking performed by an oral and maxillofacial surgery specialist (1, 7, and 14 days post-intervention). Timepoint: Pain: Measured on Day 1, Day 7, and Day 14 post-intervention by the means of through examination and history taking performed by an oral and maxillofacial surgery expert. Method of measurement: Pain in temporomandibular joints, wether in use or not, and tenderness while being examined was assessed thorough a complete examination and history taking by an oral and maxillofacial surgery specialist.;Tissue healing: Clinically evaluated by the oral and maxillofacial surgeon to observe the degree of tissue regeneration and wound healing. Timepoint: Tissue healing: Clinically evaluated on Day 1, Day 7, and Day 14 post-intervention by the oral and maxillofacial surgeon. Method of measurement: Tissue healing: Tissue healing will be evaluated through clinical examination by the oral and maxillofacial surgeon. This includes checking for the presence of swelling, redness, and signs of tissue regeneration and wound closure on Day 1, Day 7, and Day 14 post-intervention.	—

Measure

Time frame

Pain: Measured by the means of a thorough examination and history taking performed by an oral and maxillofacial surgery specialist (1, 7, and 14 days post-intervention). Timepoint: Pain: Measured on Day 1, Day 7, and Day 14 post-intervention by the means of through examination and history taking performed by an oral and maxillofacial surgery expert. Method of measurement: Pain in temporomandibular joints, wether in use or not, and tenderness while being examined was assessed thorough a complete examination and history taking by an oral and maxillofacial surgery specialist.;Tissue healing: Clinically evaluated by the oral and maxillofacial surgeon to observe the degree of tissue regeneration and wound healing. Timepoint: Tissue healing: Clinically evaluated on Day 1, Day 7, and Day 14 post-intervention by the oral and maxillofacial surgeon. Method of measurement: Tissue healing: Tissue healing will be evaluated through clinical examination by the oral and maxillofacial surgeon. This includes checking for the presence of swelling, redness, and signs of tissue regeneration and wound closure on Day 1, Day 7, and Day 14 post-intervention.

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Secondary

Measure	Time frame
Inflammation: Measured through clinical examination by the oral and maxillofacial surgeon to assess any signs of swelling, redness, or tenderness on Day 1, Day 7, and Day 14 post-intervention. Timepoint: Inflammation: Measured on Day 1, Day 7, and Day 14 post-intervention through clinical examination by the oral and maxillofacial surgeon. Method of measurement: Inflammation: Inflammation will be assessed through clinical examination by the oral and maxillofacial surgeon, focusing on signs of swelling, redness, or tenderness.;Functional improvement: Evaluated using the SF-36 Health Survey, which includes multiple subscales to measure physical functioning, social functioning, emotional well-being, and overall health on Day 1, Day 7, Day 14 and Day 30 after the intervention. Timepoint: Functional improvement: Evaluated using the SF-36 Health Survey on Day 1, Day 7, Day 14 and Day 30 after the intervention. Method of measurement: Functional improvement: Functional improvement will be measured using the SF-36 Health Survey, which includes a series of standardized questions to evaluate various aspects of health, including physical functioning, emotional well-being, and social functioning.;GHQ12: Developed in the 1970s, the General Health Questionnaire (GHQ) is regarded as a valid and dependable instrument for evaluating mental health. The most popular of the various iterations of this survey is the GHQ-12 version. It is a 12-item mental health assessment that is assessed using the table given in the reference.The scores typically used are the binary scale (0-0-1-1) and the 4-point Likert-type scale (0-1-2-3). Responses to all items are summed up to a total score ranging from 0 to 12 (binary scale) or 0 to 36 (Likert scale), with higher scores indicating more severe impairment. Timepoint: Answers to GHQ-12 were assessed 1, 7, 14 and 30 days after intervention. Method of measurement: Scores regarding answers to GHQ-12 questionnaires on days 1, 7, 14 and 30 post-intervention	—

Measure

Time frame

Inflammation: Measured through clinical examination by the oral and maxillofacial surgeon to assess any signs of swelling, redness, or tenderness on Day 1, Day 7, and Day 14 post-intervention. Timepoint: Inflammation: Measured on Day 1, Day 7, and Day 14 post-intervention through clinical examination by the oral and maxillofacial surgeon. Method of measurement: Inflammation: Inflammation will be assessed through clinical examination by the oral and maxillofacial surgeon, focusing on signs of swelling, redness, or tenderness.;Functional improvement: Evaluated using the SF-36 Health Survey, which includes multiple subscales to measure physical functioning, social functioning, emotional well-being, and overall health on Day 1, Day 7, Day 14 and Day 30 after the intervention. Timepoint: Functional improvement: Evaluated using the SF-36 Health Survey on Day 1, Day 7, Day 14 and Day 30 after the intervention. Method of measurement: Functional improvement: Functional improvement will be measured using the SF-36 Health Survey, which includes a series of standardized questions to evaluate various aspects of health, including physical functioning, emotional well-being, and social functioning.;GHQ12: Developed in the 1970s, the General Health Questionnaire (GHQ) is regarded as a valid and dependable instrument for evaluating mental health. The most popular of the various iterations of this survey is the GHQ-12 version. It is a 12-item mental health assessment that is assessed using the table given in the reference.The scores typically used are the binary scale (0-0-1-1) and the 4-point Likert-type scale (0-1-2-3). Responses to all items are summed up to a total score ranging from 0 to 12 (binary scale) or 0 to 36 (Likert scale), with higher scores indicating more severe impairment. Timepoint: Answers to GHQ-12 were assessed 1, 7, 14 and 30 days after intervention. Method of measurement: Scores regarding answers to GHQ-12 questionnaires on days 1, 7, 14 and 30 post-intervention

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactYousef Moradi

Sanandaj University of Medical Sciences

Yousefmoradi211@yahoo.com+98 918 384 7065

Outcome results

None listed

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