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Reducing Gingival Pigmentation Through Workplace Mitigation in Restaurant Oven Workers

NCT07805824 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-09-04

No results posted yet for this study

Summary

Restaurant workers who spend much of their workday near ovens, grills, or other cooking equipment may breathe smoke and experience high heat. This study will test whether a workplace safety package can lower these exposures and reduce changes in the natural coloring of the gums.

Twenty restaurants and about 200 adult workers will take part. Restaurants, rather than individual workers, will be assigned by chance to receive the safety package immediately or after the 24-week comparison period. The package may include improving exhaust hoods and ventilation, maintaining cooking equipment, shielding hot surfaces, scheduled work, rest and hydration, task rotation, worker education, and respiratory protection during high-exposure tasks.

Researchers will assess workers at the beginning of the study and again at 12 and 24 weeks. They will measure gum color using standardized photographs, air pollution, carbon monoxide, heat, gum health, and work-related symptoms. Researchers will also study selected saliva, urine, and mouth-cell markers related to inflammation, oxidative stress, and pigment pathways. The study will determine whether reducing workplace heat and air pollution is associated with less change in gum coloring and related biological changes.

Conditions

  • Gingival Pigmentation
  • Occupational Heat Exposure
  • Occupational Air Pollution Exposure

Interventions

OTHER

Workplace Heat and Air Pollution Mitigation Package

Restaurants assigned to this arm will receive a workplace heat and air-pollution mitigation package. Engineering controls include optimization of local exhaust ventilation, installation of additional source-capture hoods where feasible, maintenance of cooking equipment to reduce incomplete combustion, and shielding or insulation of radiant heat sources. Administrative controls include work-rest-hydration schedules based on wet bulb globe temperature monitoring, task rotation, and worker education on exposure recognition and symptom reporting. Task-appropriate respiratory protection, with a minimum N95 filtering facepiece, will be used during high-exposure tasks such as charcoal ignition, deep frying, and oven cleaning. Implementation will be completed within six weeks after randomization. Ventilation performance, work-rest procedures, and area PM2.5 will be monitored during follow-up.

OTHER

Delayed Workplace Heat and Air Pollution Mitigation Package

Restaurants assigned to this arm will not receive the mitigation package during the 24-week primary comparison period. They will receive the identical workplace heat and air-pollution mitigation package after the 24-week primary endpoint. The package includes engineering controls, administrative controls, worker education, and task-appropriate respiratory protection as described for the immediate-mitigation arm.

Sponsors & Collaborators

  • Salah M. Ibrahim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-01-01
Completion
2026-06-30

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805824 on ClinicalTrials.gov