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ChewingHortEvaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

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What is being tested

chewing gum

Other
Who is being recruted

Arteritis+13

+ Autoimmune Diseases

+ Brain Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorUniversity Hospital, Limoges
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 30, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
NCT04010097
Principal SponsorUniversity Hospital, Limoges
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArteritisAutoimmune DiseasesBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersImmune System DiseasesNervous System DiseasesSkin DiseasesGiant Cell ArteritisVascular DiseasesVasculitisSkin and Connective Tissue DiseasesSkin Diseases, VascularAutoimmune Diseases of the Nervous SystemVasculitis, Central Nervous System

Criteria

7 inclusion criteria required to participate
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

Show More Criteria

5 exclusion criteria prevent from participating
Group 1

Patients known to have a temporomandibular joint pathology

Patients who started corticosteroid therapy Group 2

Patients known to have temporomandibular joint pathology

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic

Group II

Active Comparator
The test involves chewing a chewing gum for 4 minutes

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

CH Avignon

Avignon, FranceOpen CH Avignon in Google Maps
Suspended

CH Valenciennes

Valenciennes, France
Suspended

CHU Limoges

Limoges, France
Suspended

CHU de Nantes

Nantes, France
Suspended6 Study Centers