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Completed

NCT Number: NCT07824661

Impact of Cessation of Toothpaste in Patients With Migraine Headaches

Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, we will be replacing toothpaste with saline water in a group of persons with migraine and compare them with another group of persons with migraine who will continue the use of toothpaste.

Both the groups will have the same treatment protocol with the only difference being the intervention of changing the toothpaste with saline.

This study will show whether this lifestyle intervention can improve headache frequency in persons with migraine over a four week period.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. John's Medical College Hospital

Bengaluru, Karnataka, 560034, India

About this study

Migraine headaches affect approximately 40% of the population and is one of the most prevalent and disabling neurological disorders worldwide. Although there are currently several medications available for the prevention of migraine attacks a majority of patients, with chronic and episodic migraines have experienced treatment failure, which greatly affects their personal, social and professional lives. Commonly used migraine preventive therapies such as topiramate, propranolol, amitriptyline and valproate may have unacceptable side effects leading to poor adherence.

Few recent papers have implicated substances in toothpaste to trigger headache attacks. Multiple ingredients in commonly used toothpaste such as nitrates, fluorides, benzoate, sorbitol, eucalyptol, camphor, etc., have the potential to cause headaches.

In this randomized physician-blinded controlled pilot exploratory study, we report the impact of toothpaste cessation on headache frequency and severity in patients with migraine headaches (PwM).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18-59 years of age who had migraine with or without aura and who were not on any prophylactic medicines will be enrolled for participation in the study. Migraine is defined in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD3).

Exclusion criteria

  • Patients with a history of hemiplegic migraine, cluster headache, and other trigeminal autonomic cephalalgias, and secondary headaches will be excluded.

Treatment and study plan

Toothpaste Cessation

Other

The participants randomised to the intervention group will be asked to replace toothpaste with normal saline (0.9%) to brush their teeth. They will be advised not to use toothpowder, neem sticks or any other alternative dentifrices.

Other names: Stopping toothpaste

Primary outcomes

  1. Headache frequency

    Time frame: 4 weeks

    The primary outcome of the study is to assess the change in the mean number of headache days from baseline to the fourth week.

Secondary outcomes

  1. Headache Severity

    Time frame: 4 weeks

    Secondary outcomes are change in headache severity on a numerical rating scale of 0-10 (0 - no pain, 10 - worst pain), proportion of patients with complete pain freedom, proportion of patients with more than 50% headache reduction in mean number of headache days.

Sponsors and collaborators

Lead sponsor

St.John's National Academy of Health Sciences

Other

Registry information

Official study title

A Randomized Controlled Pilot Exploratory Study on the Impact of Cessation of Toothpaste in Patients With Migraine Headaches

Acronym: STOP-Migraine

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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