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NCT05365932: IAD
Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
NA trial testing Intra auricular device (IAD) in Temporomandibular Disorder in 10 participants. Completed in 10 December 2019.
8 May 2019
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 29 November 2018 |
| Primary completion | 8 May 2019 |
| Estimated completion | 10 December 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Intra auricular device (IAD)
Conditions studied
- Temporomandibular Disorder — all drugs for Temporomandibular Disorder →
- Pain — all drugs for Pain →
- Psychosocial Impairment — all drugs for Psychosocial Impairment →
- Myofascial Pain — all drugs for Myofascial Pain →
Sponsor
Federico II University
Who can join
18 and older, any sex, with Temporomandibular Disorder or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: An innovative, non-invasive, and reversible Intra Auricular Device (IAD) has recently been introduced to treat temporomandibular muscle and joint disorders.Aim: To evaluate the effects of the IAD on pain, psychosocial domain and Pressure Pain Threshold (PPT) of masticatory muscles in patients with TMD pain. Methods: Ten subjects with TMD pain and with pain intensity higher than 30 mm on a VAS scale were included in the study. Patients received the IAD and counselling. Assessments included questionnaires of the DC/TMD Axis II questionnaires (Characteristic Pain Index, Interference, Jaw Functional Limitation Scale, Patient Health Questionnaire 9, Patient Health Questionnaire 15, Generalized Anxiety Disorder scale, Oral Behavior Checklist and Oral Health Impact Profile-22, Axis I clinical examination and PPTs at baseline (T0), after one month (T1), three months (T2) and six months (T3) from the first use of the device. PPTs were measured at anterior temporalis muscles, masseter muscles and right thenar as a control site.The Shapiro-Wilk test was used for the normal distribution of data. The difference among the longitudinal timepoints for variable was analysed with ANOVA. Statistical significance was accepted at p \< 0.05.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05365932
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Federico II University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05365932 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 9 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05365932.
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