MigraineSTOP-MigraineNCT07824661
Impact of Cessation of Toothpaste in Patients With Migraine Headaches
A study testing Toothpaste Cessation in people with Migraine, run by St.John's National Academy of Health Sciences at 1 site in India.
Trial summary
Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, the investigators 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Migraine
- What is being tested?
- Toothpaste Cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteIndia
- Study dates
- 17 Feb 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Patients with a history of hemiplegic migraine, cluster headache, and other trigeminal autonomic cephalalgias, and secondary headaches will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Exploratory Study on the Impact of Cessation of Toothpaste in Patients With Migraine Headaches
Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, the investigators 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.
Read the detailed description
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, the investigators report the impact of toothpaste cessation on headache frequency and severity in patients with migraine headaches (PwM).
- Conditions
- Migraine
- Being tested
- Toothpaste Cessation
- Keywords
- Migraine, Toothpaste, Kindling, Lifestyle intervention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste CessationOther
Also called Stopping toothpaste
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.
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste Cessation Arm | Experimental | This is the group that will be asked to replace toothpaste with saline Receives: Other: Toothpaste Cessation |
| Toothpaste Continuation Arm | No intervention | This is the group that will continue using toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
The primary outcome of the study is to assess the change in the mean number of headache days from baseline to the fourth week.
Measured: 4 weeks
Secondary outcomes (1)
Headache Severity
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start17 Feb 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- St.John's National Academy of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mathew, St.John's National Academy of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824661
- Sponsor's protocol ID
- 231/2024
- Acronym
- STOP-Migraine
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be made available upon request with appropriate ethical approvals.
Publications
Mathew T, John SK. An unsuspected and unrecognized cause of medication overuse headache in a chronic migraineur-essential oil-related medication overuse headache: A case report. Cephalalgia Reports. 2020;3. doi:10.1177/2515816319897054
Mathew T, John SK, Kamath V, Kumar R S, Jadav R, Shaji A, Nadig R, Sarma GRK, Parry GJ. Essential oil-related status epilepticus: A small case series study. J Am Coll Emerg Physicians Open. 2020 Jun 25;1(5):918-921. doi: 10.1002/emp2.12147. eCollection 2020 Oct.
PubMed 33145540Mathew T, K John S, Kamath V, Kumar R S, Jadav R, Swamy S, Adoor G, Shaji A, Nadig R, Badachi S, D Souza D, Therambil M, Sarma GRK, J Parry G. Essential oil related seizures (EORS): A multi-center prospective study on essential oils and seizures in adults. Epilepsy Res. 2021 Jul;173:106626. doi: 10.1016/j.eplepsyres.2021.106626. Epub 2021 Mar 26.
PubMed 33813360Mathew T, John SK, Javali M, Vasireddy M, Nadig R, Sarma GRK. Substance use related cluster headache: A case series. Headache. 2022 Jul;62(7):908-910. doi: 10.1111/head.14364. Epub 2022 Jul 20.
PubMed 35856604Mathew T, Bhardwaj S, Garg S, Nambiar SV, Sathyaprabha TN. A Simple Experiment to Test the Toxicity of Toothpaste (3T Experiment): An Observational Pilot Study. Cureus. 2024 Sep 9;16(9):e68978. doi: 10.7759/cureus.68978. eCollection 2024 Sep.
PubMed 39385925American Headache Society 68th Annual Scientific Meeting June 4-7, 2026, Orlando, Florida. Headache. 2026 Jun;66 Suppl 1:S4-S207. doi: 10.1111/head.70117. No abstract available.
PubMed 42231798Mathew T, Bhardwaj S, Goyal A, Bhatt A, Mahadevan A, Kashif MS, Karau PB, Mitra D, V V B, Pullikan J, Jose J, Kukkemane K, Majumdar P, Thankachan P, Nadig R. Exploring toothpaste ingredients as potential chemical kindling agents in neuropsychiatric disorders: An adult zebrafish (Danio rerio) study. IBRO Neurosci Rep. 2026 Jul 10;21:301-307. doi: 10.1016/j.ibneur.2026.07.008. eCollection 2026 Dec.
PubMed 42518967
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Exploratory Study on the Impact of Cessation of Toothpaste in Patients With Migraine Headaches
- ClinicalTrials.gov ID
- NCT07824661
- Acronym / sponsor ID
- STOP-Migraine / 231/2024
- Conditions
- Migraine
- Keywords
- Migraine, Toothpaste, Kindling, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- St.John's National Academy of Health SciencesUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, the investigators 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.
Detailed description
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, the investigators report the impact of toothpaste cessation on headache frequency and severity in patients with migraine headaches (PwM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste Cessation Arm | Experimental | Other: Toothpaste CessationThis is the group that will be asked to replace toothpaste with saline |
| Toothpaste Continuation Arm | No intervention | –This is the group that will continue using toothpaste |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients with a history of hemiplegic migraine, cluster headache, and other trigeminal autonomic cephalalgias, and secondary headaches will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste CessationAlso: Stopping toothpasteThe 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 | Toothpaste Cessation Arm |
Primary outcome
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.
1 secondary outcome
Headache Severity
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- BackgroundMathew T, John SK. An unsuspected and unrecognized cause of medication overuse headache in a chronic migraineur-essential oil-related medication overuse headache: A case report. Cephalalgia Reports. 2020;3. doi:10.1177/2515816319897054
- Background: PubMed 33145540Mathew T, John SK, Kamath V, Kumar R S, Jadav R, Shaji A, Nadig R, Sarma GRK, Parry GJ. Essential oil-related status epilepticus: A small case series study. J Am Coll Emerg Physicians Open. 2020 Jun 25;1(5):918-921. doi: 10.1002/emp2.12147. eCollection 2020 Oct.
- Background: PubMed 33813360Mathew T, K John S, Kamath V, Kumar R S, Jadav R, Swamy S, Adoor G, Shaji A, Nadig R, Badachi S, D Souza D, Therambil M, Sarma GRK, J Parry G. Essential oil related seizures (EORS): A multi-center prospective study on essential oils and seizures in adults. Epilepsy Res. 2021 Jul;173:106626. doi: 10.1016/j.eplepsyres.2021.106626. Epub 2021 Mar 26.
- Background: PubMed 35856604Mathew T, John SK, Javali M, Vasireddy M, Nadig R, Sarma GRK. Substance use related cluster headache: A case series. Headache. 2022 Jul;62(7):908-910. doi: 10.1111/head.14364. Epub 2022 Jul 20.
- Background: PubMed 39385925Mathew T, Bhardwaj S, Garg S, Nambiar SV, Sathyaprabha TN. A Simple Experiment to Test the Toxicity of Toothpaste (3T Experiment): An Observational Pilot Study. Cureus. 2024 Sep 9;16(9):e68978. doi: 10.7759/cureus.68978. eCollection 2024 Sep.
- Background: PubMed 42231798American Headache Society 68th Annual Scientific Meeting June 4-7, 2026, Orlando, Florida. Headache. 2026 Jun;66 Suppl 1:S4-S207. doi: 10.1111/head.70117. No abstract available.
- Background: PubMed 42518967Mathew T, Bhardwaj S, Goyal A, Bhatt A, Mahadevan A, Kashif MS, Karau PB, Mitra D, V V B, Pullikan J, Jose J, Kukkemane K, Majumdar P, Thankachan P, Nadig R. Exploring toothpaste ingredients as potential chemical kindling agents in neuropsychiatric disorders: An adult zebrafish (Danio rerio) study. IBRO Neurosci Rep. 2026 Jul 10;21:301-307. doi: 10.1016/j.ibneur.2026.07.008. eCollection 2026 Dec.
- Individual participant dataSharing planned: Undecided. The data will be made available upon request with appropriate ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste Cessation in people with Migraine, run by St.John's National Academy of Health Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824661, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.