Temporomandibular Disorders (TMD)NCT07598994
Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain
A study testing Capsaicin Topical Cream and Diclofenac 1% Topical in people with Temporomandibular Disorders (TMD) and Temporomandibular Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effectiveness and safety of topical capsaicin cream and topical diclofenac gel in women with chronic temporomandibular joint-related pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Temporomandibular Disorders (TMD), Temporomandibular Pain
- What is being tested?
- Capsaicin Topical Cream and Diclofenac 1% Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 6 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged between 18 and 65 years
- Diagnosis of temporomandibular disorder (TMD)-related pain
- Presence of pain for at least 3 months
- Baseline pain intensity sufficient to require treatment
- Willingness to comply with study procedures and follow-up visits
- Signed informed consent form
Who cannot join
- Pregnancy or breastfeeding
- History of allergy or hypersensitivity to capsaicin or diclofenac
- Presence of systemic inflammatory or neurological disease
- Use of systemic analgesics, corticosteroids, or muscle relaxants during the study period
- Active skin lesions or dermatologic disease in the application area
- Previous temporomandibular joint surgery
- Participation in another clinical trial within the last 30 days
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, Istanbul, 34093
About this study
Official title: Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain: A Randomized, Prospective, Single-Blind Clinical Trial
The goal of this clinical trial is to compare the effectiveness and safety of topical capsaicin cream and topical diclofenac gel in women with chronic temporomandibular joint-related pain. The main questions it aims to answer are:
- Does topical capsaicin reduce pain intensity more effectively than topical diclofenac?
- Do the treatments improve jaw function, pressure pain threshold, and neuropathic pain symptoms?
Read more
Researchers will compare topical capsaicin cream with topical diclofenac gel to evaluate differences in pain relief and functional improvement.
Participants will:
- Apply the assigned topical medication four times daily for 7 days
- Attend clinical examinations and pain assessments at baseline, Day 8, and Month 1
- Complete pain-related questionnaires and functional jaw measurements during follow-up visits
Read the detailed description
This randomized prospective single-blind clinical trial was designed to evaluate the efficacy and safety of topical capsaicin cream compared with topical diclofenac diethylammonium gel in female patients with chronic temporomandibular joint-related pain. Fifty women aged between 18 and 65 years diagnosed with temporomandibular disorders were randomly assigned to either the capsaicin group or the diclofenac group.
Participants in the capsaicin group applied 0.075% topical capsaicin cream, while participants in the diclofenac group applied 1% diclofenac diethylammonium gel. Both medications were applied four times daily over the temporomandibular joint lateral pole region for 7 days. Existing occlusal splint therapy was continued throughout the study period.
Clinical evaluations were performed at baseline, Day 8, and Month 1. Outcome measures included pain intensity assessed with a visual analog scale, multidimensional pain assessment using the McGill Pain Questionnaire, neuropathic pain evaluation using the DN4 questionnaire, pressure pain threshold measurements, maximum mouth opening, lateral mandibular movements, clinician global impression of change, and adverse effects.
The study was approved by the Istanbul University Faculty of Dentistry Clinical Research Ethics Committee and conducted in accordance with the Declaration of Helsinki.
- Being tested
- Capsaicin Topical Cream, Diclofenac 1% Topical
- Keywords
- Capsaicin, Diclofenac, Temporomandibular Disorders, Topical Treatment
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin Topical CreamDrug
Also called Capsaicin 0.075% Cream
Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.
Diclofenac 1% TopicalDrug
Also called Diclofenac Diethylammonium 1% Gel
Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin Group | Experimental | Participants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days. Receives: Drug: Capsaicin Topical Cream |
| Diclofenac Group | Active comparator | Participants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days. Receives: Drug: Diclofenac 1% Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity measured by Visual Analog Scale (VAS)
Pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS) in patients with temporomandibular disorder-related pain. Changes in VAS scores were compared between the capsaicin and diclofenac
Measured: Baseline, Day 8, and 1 Month
Secondary outcomes (6)
Pressure Pain Threshold
Pressure pain threshold over the temporomandibular joint lateral pole measured using a dolorimeter.
Measured: Baseline, Day 8, and 1 Month
Maximum Mouth Opening
Maximum interincisal mouth opening measured in millimeters.
Measured: Baseline, Day 8, and 1 Month
McGill Pain Questionnaire Scores
Pain severity assessed using the McGill Pain Questionnaire.
Measured: Baseline, Day 8, and 1 Month
DN4 Neuropathic Pain Scores
Neuropathic pain symptoms assessed using the DN4 questionnaire.
Measured: Baseline, Day 8, and 1 Month
Lateral Excursion Measurements
Right and left mandibular lateral excursion movements measured in millimeters.
Measured: Baseline, Day 8, and 1 Month
Clinician Global Impression of Change (CGIC)
Clinical improvement assessed using the Clinician Global Impression of Change scale.
Measured: Day 8, and 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start28 Aug 2025
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel treatment groups receiving either topical capsaicin cream or topical diclofenac diethylammonium gel for temporomandibular joint-related pain.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Yesim Eren, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598994
- Sponsor's protocol ID
- 25AKD83
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding individual participant data sharing has not yet been finalized.
Publications
Mena M, Dalbah L, Levi L, Padilla M, Enciso R. Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis. J Dent Anesth Pain Med. 2020 Dec;20(6):337-356. doi: 10.17245/jdapm.2020.20.6.337. Epub 2020 Dec 28.
PubMed 33409363Haanpaa M, Treede RD. Capsaicin for neuropathic pain: linking traditional medicine and molecular biology. Eur Neurol. 2012;68(5):264-75. doi: 10.1159/000339944. Epub 2012 Sep 28.
PubMed 23037991Klinge SA, Sawyer GA. Effectiveness and safety of topical versus oral nonsteroidal anti-inflammatory drugs: a comprehensive review. Phys Sportsmed. 2013 May;41(2):64-74. doi: 10.3810/psm.2013.05.2016.
PubMed 23703519Alomar X, Medrano J, Cabratosa J, Clavero JA, Lorente M, Serra I, Monill JM, Salvador A. Anatomy of the temporomandibular joint. Semin Ultrasound CT MR. 2007 Jun;28(3):170-83. doi: 10.1053/j.sult.2007.02.002.
PubMed 17571700Gan TJ. Diclofenac: an update on its mechanism of action and safety profile. Curr Med Res Opin. 2010 Jul;26(7):1715-31. doi: 10.1185/03007995.2010.486301.
PubMed 20470236Craft RM, Mogil JS, Aloisi AM. Sex differences in pain and analgesia: the role of gonadal hormones. Eur J Pain. 2004 Oct;8(5):397-411. doi: 10.1016/j.ejpain.2004.01.003.
PubMed 15324772Harper DE, Schrepf A, Clauw DJ. Pain Mechanisms and Centralized Pain in Temporomandibular Disorders. J Dent Res. 2016 Sep;95(10):1102-8. doi: 10.1177/0022034516657070. Epub 2016 Jun 28.
PubMed 27422858Busse JW, Casassus R, Carrasco-Labra A, Durham J, Mock D, Zakrzewska JM, Palmer C, Samer CF, Coen M, Guevremont B, Hoppe T, Guyatt GH, Crandon HN, Yao L, Sadeghirad B, Vandvik PO, Siemieniuk RAC, Lytvyn L, Hunskaar BS, Agoritsas T. Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. BMJ. 2023 Dec 15;383:e076227. doi: 10.1136/bmj-2023-076227.
PubMed 38101929
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain: A Randomized, Prospective, Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07598994
- Acronym / sponsor ID
- 25AKD83
- Keywords
- Capsaicin, Diclofenac, Temporomandibular Disorders, Topical Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effectiveness and safety of topical capsaicin cream and topical diclofenac gel in women with chronic temporomandibular joint-related pain. The main questions it aims to answer are:
- Does topical capsaicin reduce pain intensity more effectively than topical diclofenac?
- Do the treatments improve jaw function, pressure pain threshold, and neuropathic pain symptoms?
Researchers will compare topical capsaicin cream with topical diclofenac gel to evaluate differences in pain relief and functional improvement.
Participants will:
- Apply the assigned topical medication four times daily for 7 days
- Attend clinical examinations and pain assessments at baseline, Day 8, and Month 1
- Complete pain-related questionnaires and functional jaw measurements during follow-up visits
Detailed description
This randomized prospective single-blind clinical trial was designed to evaluate the efficacy and safety of topical capsaicin cream compared with topical diclofenac diethylammonium gel in female patients with chronic temporomandibular joint-related pain. Fifty women aged between 18 and 65 years diagnosed with temporomandibular disorders were randomly assigned to either the capsaicin group or the diclofenac group.
Participants in the capsaicin group applied 0.075% topical capsaicin cream, while participants in the diclofenac group applied 1% diclofenac diethylammonium gel. Both medications were applied four times daily over the temporomandibular joint lateral pole region for 7 days. Existing occlusal splint therapy was continued throughout the study period.
Clinical evaluations were performed at baseline, Day 8, and Month 1. Outcome measures included pain intensity assessed with a visual analog scale, multidimensional pain assessment using the McGill Pain Questionnaire, neuropathic pain evaluation using the DN4 questionnaire, pressure pain threshold measurements, maximum mouth opening, lateral mandibular movements, clinician global impression of change, and adverse effects.
The study was approved by the Istanbul University Faculty of Dentistry Clinical Research Ethics Committee and conducted in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel treatment groups receiving either topical capsaicin cream or topical diclofenac diethylammonium gel for temporomandibular joint-related pain.
| Arm | Type | Receives |
|---|---|---|
| Capsaicin Group | Experimental | Drug: Capsaicin Topical CreamParticipants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days. |
| Diclofenac Group | Active comparator | Drug: Diclofenac 1% TopicalParticipants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female participants aged between 18 and 65 years
- Diagnosis of temporomandibular disorder (TMD)-related pain
- Presence of pain for at least 3 months
- Baseline pain intensity sufficient to require treatment
- Willingness to comply with study procedures and follow-up visits
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- History of allergy or hypersensitivity to capsaicin or diclofenac
- Presence of systemic inflammatory or neurological disease
- Use of systemic analgesics, corticosteroids, or muscle relaxants during the study period
- Active skin lesions or dermatologic disease in the application area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin Topical CreamAlso: Capsaicin 0.075% CreamTopical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days. | Drug | Capsaicin Group |
| Diclofenac 1% TopicalAlso: Diclofenac Diethylammonium 1% GelTopical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days. | Drug | Diclofenac Group |
Primary outcome
Change in pain intensity measured by Visual Analog Scale (VAS)
Time frame: Baseline, Day 8, and 1 Month
Pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS) in patients with temporomandibular disorder-related pain. Changes in VAS scores were compared between the capsaicin and diclofenac
6 secondary outcomes
Pressure Pain Threshold
Time frame: Baseline, Day 8, and 1 Month
Maximum Mouth Opening
Time frame: Baseline, Day 8, and 1 Month
McGill Pain Questionnaire Scores
Time frame: Baseline, Day 8, and 1 Month
DN4 Neuropathic Pain Scores
Time frame: Baseline, Day 8, and 1 Month
Lateral Excursion Measurements
Time frame: Baseline, Day 8, and 1 Month
Clinician Global Impression of Change (CGIC)
Time frame: Day 8, and 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 33409363Mena M, Dalbah L, Levi L, Padilla M, Enciso R. Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis. J Dent Anesth Pain Med. 2020 Dec;20(6):337-356. doi: 10.17245/jdapm.2020.20.6.337. Epub 2020 Dec 28.
- Background: PubMed 23037991Haanpaa M, Treede RD. Capsaicin for neuropathic pain: linking traditional medicine and molecular biology. Eur Neurol. 2012;68(5):264-75. doi: 10.1159/000339944. Epub 2012 Sep 28.
- Background: PubMed 23703519Klinge SA, Sawyer GA. Effectiveness and safety of topical versus oral nonsteroidal anti-inflammatory drugs: a comprehensive review. Phys Sportsmed. 2013 May;41(2):64-74. doi: 10.3810/psm.2013.05.2016.
- Background: PubMed 17571700Alomar X, Medrano J, Cabratosa J, Clavero JA, Lorente M, Serra I, Monill JM, Salvador A. Anatomy of the temporomandibular joint. Semin Ultrasound CT MR. 2007 Jun;28(3):170-83. doi: 10.1053/j.sult.2007.02.002.
- Background: PubMed 20470236Gan TJ. Diclofenac: an update on its mechanism of action and safety profile. Curr Med Res Opin. 2010 Jul;26(7):1715-31. doi: 10.1185/03007995.2010.486301.
- Background: PubMed 15324772Craft RM, Mogil JS, Aloisi AM. Sex differences in pain and analgesia: the role of gonadal hormones. Eur J Pain. 2004 Oct;8(5):397-411. doi: 10.1016/j.ejpain.2004.01.003.
- Background: PubMed 27422858Harper DE, Schrepf A, Clauw DJ. Pain Mechanisms and Centralized Pain in Temporomandibular Disorders. J Dent Res. 2016 Sep;95(10):1102-8. doi: 10.1177/0022034516657070. Epub 2016 Jun 28.
- Background: PubMed 38101929Busse JW, Casassus R, Carrasco-Labra A, Durham J, Mock D, Zakrzewska JM, Palmer C, Samer CF, Coen M, Guevremont B, Hoppe T, Guyatt GH, Crandon HN, Yao L, Sadeghirad B, Vandvik PO, Siemieniuk RAC, Lytvyn L, Hunskaar BS, Agoritsas T. Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. BMJ. 2023 Dec 15;383:e076227. doi: 10.1136/bmj-2023-076227.
- Individual participant dataSharing planned: Undecided. The decision regarding individual participant data sharing has not yet been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin Topical Cream and Diclofenac 1% Topical in people with Temporomandibular Disorders (TMD) and Temporomandibular Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Visual Analog Scale (VAS) (time frame: Baseline, Day 8, and 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07598994, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.