Comparing a custom dental splint with standard headache medicines for tension-type headache and migraine

Occlusal splint therapy versus standard pharmacotherapy in patients with tension-type headache and migraine: an interdisciplinary dental–neurological comparative study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15938173

Enrollment

Registered

2026-07-27

Start date

2024-04-30

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-type headache and migraine (ICHD-3 criteria), with comorbid assessment of temporomandibular disorder and nocturnal bruxism Nervous System Diseases

Interventions

Patients in the splint group (n=60) received an individually fabricated hard-acrylic stabilisation occlusal splint, with vertical thickness determined by cephalometric analysis, following structured p

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years 2. Neurologist-confirmed primary headache diagnosis of tension-type headache or migraine according to ICHD-3 criteria 3. Minimum 3 months of active headache history 4. At least 4 headache days per month

Exclusion criteria

Exclusion criteria: 1. Secondary headache aetiology 2. Prior occlusal splint use within 12 months 3. Active inflammatory or infectious disease 4. Acute temporomandibular joint inflammation requiring immediate surgical intervention 5. Pregnancy 6. Refusal of informed consent

Design outcomes

Primary

Measure	Time frame
Headache pain intensity measured using Numerical Rating Scale (NRS, 0–10) at Baseline, 2 weeks, 6 weeks, and 12 weeks	—

Secondary

Measure	Time frame
Headache-related disability measured using Migraine Disability Assessment (MIDAS) score at Baseline, 2 weeks, 6 weeks, and 12 weeks;Headache frequency measured using Self-reported number of headache days per month at Baseline, 2 weeks, 6 weeks, and 12 weeks;Depression and anxiety symptoms measured using Patient Health Questionnaire-4 (PHQ-4) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Generalised anxiety symptoms measured using Generalised Anxiety Disorder-7 (GAD-7) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Pain localisation measured using Pain drawing (body/facial pain map) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Pharmacological consumption measured using Self-reported analgesic and triptan use at Baseline, 2 weeks, 6 weeks, and 12 weeks	—

Measure

Time frame

Headache-related disability measured using Migraine Disability Assessment (MIDAS) score at Baseline, 2 weeks, 6 weeks, and 12 weeks;Headache frequency measured using Self-reported number of headache days per month at Baseline, 2 weeks, 6 weeks, and 12 weeks;Depression and anxiety symptoms measured using Patient Health Questionnaire-4 (PHQ-4) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Generalised anxiety symptoms measured using Generalised Anxiety Disorder-7 (GAD-7) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Pain localisation measured using Pain drawing (body/facial pain map) at Baseline, 2 weeks, 6 weeks, and 12 weeks;Pharmacological consumption measured using Self-reported analgesic and triptan use at Baseline, 2 weeks, 6 weeks, and 12 weeks

—

Countries

Poland

Contacts

Public ContactKatarzyna Kepczynska

katarzyna.kepczynska@wum.edu.pl+48 22 56 90 239

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026