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NCT02966067
A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery
NA trial testing Microneedle Device (Experimental) in Dental Pain in 5 participants. Completed in 8 December 2017.
1 December 2017
Quick facts
| Lead sponsor | University of Dublin, Trinity College |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 5 |
| Start date | 1 September 2017 |
| Primary completion | 1 December 2017 |
| Estimated completion | 8 December 2017 |
| Sites | 1 location across Ireland |
Drugs / interventions tested
- Microneedle Device (Experimental)
- 30-gauge Short Hypodermic Needle
Conditions studied
- Dental Pain — all drugs for Dental Pain →
- Anesthesia, Local — all drugs for Anesthesia, Local →
Sponsor
University of Dublin, Trinity College
Who can join
18 and older, male only, with Dental Pain or Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will be completed as a two part, prospective, single-centre, randomised controlled trial. Five volunteers (dentists) will be recruited in the first part of the study to evaluate and examine the microneedle device and its use. Based on those qualitative findings (individual interviews and focus group) modifications to the microneedle device will be implemented before part two of the study commences. Twenty volunteers will be enrolled in the second part of the study. A split mouth design will be used to compare the efficacy of an array of 2x3 pyramidal wet-etch silicone microneedles of 280µm height with a standard 30-gauge short hypodermic needle in the delivery of local dental anaesthetic solution. Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded and compared.
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 NCT02966067
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University of Dublin, Trinity College 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 NCT02966067 (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 University of Dublin, Trinity College
- Last refreshed: 25 January 2018
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/NCT02966067.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing