Studies of the treatment effect of botulinum toxin A on patients with neurogenic pain in the mouth

Phase 1

• Conditions: Atypical Odontalgia/Persistent Dentoalveolar Pain; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

• Registration Number: EUCTR2019-003503-35-SE
• Lead Sponsor: Region Östergötland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

•´A diagnosis of PDAP/AO with all of the following four criteria fulfilled:
1) Persistent pain (pain at least 8 h per day, at least >15 days per month for >3 months) localized in the dento-alveolar region
2) Pain onset is in close temporal relation to a causal event (e.g. dental procedures, facial trauma)
3) Somatosensory abnormalities are present in the painful area.
4) Not caused by another disease or disorder
• Daily pain for at least 6 months (according to patient report)
• Average pain intensity of > 5 on a numeric rating scale.
• >18 years of age
• For women of child-bearing potential:
a negative highly sensitive urine pregnancy test, and
agree to use an effective method of contraception (progestogen-only hormonal contraception, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) as a minimum used until treatment discontinuation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• inflammatory tooth pain, trigeminal neuralgia, trigeminal autonomic cephalalgias, myasthenia gravis, amyotrophic lateral sclerosis,
• known hypersensitivity for botulinum toxin A
• Inflammation in the site of injection
• Pregnancy or nursing,
• History of drug or alcohol abuse,
• coagulation disorders
• previous use of BTX-A in the orofacial region during the last 6 months
• use of drugs that exerts its effect on neuromuscular junctions or coagulation disorders
• major psychiatric disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified