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

NCT ID: NCT04010097

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2022-01-01

Brief 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).

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Horton group

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

Group Type: EXPERIMENTAL

chewing gum

Intervention Type: OTHER

The test involves chewing a chewing gum for 4 minutes

N Horton Group

The test involves chewing a chewing gum for 4 minutes

Group Type: ACTIVE_COMPARATOR

chewing gum

Intervention Type: OTHER

The test involves chewing a chewing gum for 4 minutes

Interventions

chewing gum

The test involves chewing a chewing gum for 4 minutes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Avignon

Avignon, , France

CHU Limoges

Limoges, , France

CHU de Nantes

Nantes, , France

CH St Antoine

Paris, , France

CHU Tours

Tours, , France

CH Valenciennes

Valenciennes, , France

Countries

France

Other Identifiers

87RI19_0009

Identifier Type: -

Identifier Source: org_study_id