Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort (ChewingHort)

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).

Study Overview

• Status: Completed
• Conditions: Horton Disease
• Intervention / Treatment: Other: chewing gum

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France
    • Ch Avignon
  • Limoges, France
    • CHU Limoges
  • Nantes, France
    • CHU de Nantes
  • Paris, France
    • CH St Antoine
  • Tours, France
    • CHU Tours
  • Valenciennes, France
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Horton group; The test involves chewing a chewing gum for 4 minutes plus a standard Horton disease diagnostic	Other: chewing gum; The test involves chewing a chewing gum for 4 minutes
Active Comparator: N Horton Group; The test involves chewing a chewing gum for 4 minutes	Other: chewing gum; The test involves chewing a chewing gum for 4 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day1

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Publications and helpful links

General 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 Apr 17:1-4. doi: 10.1080/03009742.2026.2627071. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Biological Products; Complex Mixtures; Biopolymers; Plant Gums; Plant Exudates; Candy; Chewing Gum
• Other Study ID Numbers: 87RI19_0009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No