Horton DiseaseChewingHortNCT04010097
Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
A study testing chewing gum in people with Horton Disease, run by University Hospital, Limoges at 6 sites in France.
Trial summary
It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Horton Disease
- What is being tested?
- chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesFrance
- Study dates
- 11 Oct 2019to 11 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group 1
- Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan
- Patient over 50 years old
- Patient able to chew a chewing gum for 4 minutes Group 2
- Patients free from GCA
- Age matched (± 3 years)
- Patient able to chew a chewing gum for 4 minutes
Who cannot join
- Group 1
- Patients known to have a temporomandibular joint pathology
- Patients who started corticosteroid therapy Group 2
- Patients known to have temporomandibular joint pathology
- Patients who started corticosteroid therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Avignon
Avignon
CHU Limoges
Limoges
CHU de Nantes
Nantes
CH St Antoine
Paris
CHU Tours
Tours
CH Valenciennes
Valenciennes
About this study
Official title: Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).
Read the detailed description
GCA is the most common vasculitis. The diagnosis easily could be made in patients over 50 years old with headache, inflammatory belt pain, claudication of the jaws, scalp hyperesthesia, ophthalmological manifestations and an inflammatory syndrome. However, the clinical pictures could be less suggestive, hence diagnostic difficulties. Some patients have only isolated inflammatory syndrome. To confirm the diagnosis, sometimes PET CT or temporal artery biopsy is used, but access to a PET CT is sometimes complex, biopsy of temporal arteries is only positive in about 70% cases. Early diagnosis is important, however, to avoid irreversible complications, especially ophthalmological complications. One in six patients has definitive amaurosis, because of diagnosis delay. The current diagnostic delay is estimated on average at 9 weeks.
Jaw intermittent claudication probably has a very good positive predictive value and this clinical sign often carries conviction. Patients with claudication of the jaws also have a greater visual risk. Kuo reports two observations of patients with claudication of the jaws revealed by the "chewing gum test" after 2 minutes of chewing. It is therefore proposed to perform a chewing gum test to assess the sensitivity and specificity of this test, compared to the interview.
Once the test is done, the study is completed for the patient.
- Conditions
- Horton Disease
- Being tested
- chewing gum
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
The test involves chewing a chewing gum for 4 minutes
| Study group | Role | What they receive |
|---|---|---|
| Horton group | Experimental | The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic Receives: Other: chewing gum |
| N Horton Group | Active comparator | The test involves chewing a chewing gum for 4 minutes Receives: Other: chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease.
Determination of:
True positive: Sick people correctly identified as sick False positive: Healthy people incorrectly identified as sick True negative: Healthy people correctly identified as healthy False negative: Sick people incorrectly identified as healthy
Then wa calculate:
the number true positives TP the number of false positives FP the number of true negatives TN the number of false negatives.FN
Specificty= TN/(TN+FP) Sensitivity= : TP/(TP+FN) The test is performed twice an hour apart, to verify its reproducibility, before the introduction of corticosteroid therapy, with chewing gums without sugar.
Measured: Day 1
Secondary outcomes (1)
Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,
predictive value= TP/(TP+FP)
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start11 Oct 2019
- Primary completion11 Oct 2021
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Horton DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010097
- Sponsor's protocol ID
- 87RI19_0009
- Acronym
- ChewingHort
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ratti N, Dumonteil S, Parreau S, Magnant J, Liozon E, Palat S, Bezanahary H, Desvaux E, Aslanbekova N, Agard C, Quemeneur T, Mekinian A, Pestre V, Fauchais AL, Ly KH, Gondran G. Value of the chewing gum test for the diagnosis of giant cell arteritis: a multicentre pilot study. Scand J Rheumatol. 2026 Jul;55(4):276-279. doi: 10.1080/03009742.2026.2627071. Epub 2026 Apr 17.
PubMed 41995029
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
- ClinicalTrials.gov ID
- NCT04010097
- Acronym / sponsor ID
- ChewingHort / 87RI19_0009
- Conditions
- Horton Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 8 Jul 2019 (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.
It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).
Detailed description
GCA is the most common vasculitis. The diagnosis easily could be made in patients over 50 years old with headache, inflammatory belt pain, claudication of the jaws, scalp hyperesthesia, ophthalmological manifestations and an inflammatory syndrome. However, the clinical pictures could be less suggestive, hence diagnostic difficulties. Some patients have only isolated inflammatory syndrome. To confirm the diagnosis, sometimes PET CT or temporal artery biopsy is used, but access to a PET CT is sometimes complex, biopsy of temporal arteries is only positive in about 70% cases. Early diagnosis is important, however, to avoid irreversible complications, especially ophthalmological complications. One in six patients has definitive amaurosis, because of diagnosis delay. The current diagnostic delay is estimated on average at 9 weeks.
Jaw intermittent claudication probably has a very good positive predictive value and this clinical sign often carries conviction. Patients with claudication of the jaws also have a greater visual risk. Kuo reports two observations of patients with claudication of the jaws revealed by the "chewing gum test" after 2 minutes of chewing. It is therefore proposed to perform a chewing gum test to assess the sensitivity and specificity of this test, compared to the interview.
Once the test is done, the study is completed for the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horton group | Experimental | Other: chewing gumThe test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic |
| N Horton Group | Active comparator | Other: chewing gumThe test involves chewing a chewing gum for 4 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Group 1
- Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan
- Patient over 50 years old
- Patient able to chew a chewing gum for 4 minutes Group 2
- Patients free from GCA
Key exclusion criteria (5 listed)
- Group 1
- Patients known to have a temporomandibular joint pathology
- Patients who started corticosteroid therapy Group 2
- Patients known to have temporomandibular joint pathology
- Patients who started corticosteroid therapy
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 |
|---|---|---|
| chewing gumThe test involves chewing a chewing gum for 4 minutes | Other | Horton group, N Horton Group |
Primary outcome
Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease.
Time frame: Day 1
Determination of: True positive: Sick people correctly identified as sick False positive: Healthy people incorrectly identified as sick True negative: Healthy people correctly identified as healthy False negative: Sick people incorrectly identified as healthy Then wa calculate: the number true positives TP the number of false positives FP the number of true negatives TN the number of false negatives.FN Specificty= TN/(TN+FP) Sensitivity= : TP/(TP+FN) The test is performed twice an hour apart, to verify its reproducibility, before the introduction of corticosteroid therapy, with chewing gums without sugar.
1 secondary outcome
Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,
Time frame: Day1
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 23 Apr 2026.
- Results publication: PubMed 41995029Ratti N, Dumonteil S, Parreau S, Magnant J, Liozon E, Palat S, Bezanahary H, Desvaux E, Aslanbekova N, Agard C, Quemeneur T, Mekinian A, Pestre V, Fauchais AL, Ly KH, Gondran G. Value of the chewing gum test for the diagnosis of giant cell arteritis: a multicentre pilot study. Scand J Rheumatol. 2026 Jul;55(4):276-279. doi: 10.1080/03009742.2026.2627071. Epub 2026 Apr 17.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum in people with Horton Disease, run by University Hospital, Limoges at 6 sites in France.
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 7 inclusion and 5 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease. (time frame: Day 1). 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 NCT04010097, which also lists 1 linked publication.
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 23 Apr 2026.