NCT04010097

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

June 27, 2019

Last Update Submit

April 20, 2026

Conditions

Horton Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,

    Day1

Study Arms (2)

Horton group

EXPERIMENTAL

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

Other: chewing gum

N Horton Group

ACTIVE COMPARATOR

The test involves chewing a chewing gum for 4 minutes

Other: chewing gum

Interventions

chewing gumOTHER

The test involves chewing a chewing gum for 4 minutes

Horton groupN Horton Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Avignon

Avignon, France

Location

CHU Limoges

Limoges, France

Location

CHU de Nantes

Nantes, France

Location

CH St Antoine

Paris, France

Location

CHU Tours

Tours, France

Location

CH Valenciennes

Valenciennes, France

Location

Related Publications (1)

  • 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.

    PMID: 41995029RESULT

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 8, 2019

Study Start

October 11, 2019

Primary Completion

October 11, 2021

Study Completion

October 11, 2022

Last Updated

April 23, 2026

Record last verified: 2025-04

Locations

FR(6)