Atypical Odontalgia/Persistent Dentoalveolar Pain
Conditions
Interventions
Trade Name: Dysport
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin type A - haemagglutinin complex
CAS Number: Not known
Other descriptive name: Botulinum
Sponsors
Region Östergötland
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the treatment outcome of botulinum toxin A compared to placebo (saline) on PDAP/AO patient pain assessment using NRS, measured at baseline and 24 weeks after the first BTX-A injection.;Secondary Objective: Secondary aims are to evaluate the treatment outcome of botulinum toxin A for treatment of PDAP/AO on (1) Pain related variables, evaluated with NRS, MPQ, PDRAW and by patient pain medication use; (2) Physical functioning, evaluated with GCPS, JFLS-20, OHIP-S14; (3) Emotional functioning, evaluated with PHQ-9, GAD-7, PHQ-15, PSS-10, PCS, and ISI; (4) Somatosensory abnormalities, evaluated with QualST; (5) Evaluate the safety of using botulinum toxin A for treatment of PDAP/AO by evaluation of frequencies of adverse events. (6) Patient assessed general improvement evaluated with PGIC ;Primary end point(s): Patient pain assessment using the NRS scale;Timepoint(s) of evaluation of this end point: Baseline and 24 weeks after the first BTX-A injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points and methods for evaluation are listed together with the secondary objectivs of the trial in section E.2.2.;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks, 24 weeks and 1 year after the first BTX-A injection | — |
Countries
Sweden
Contacts
Public ContactAndreas Dawson
Region Östergötland
Outcome results
None listed