Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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 in order 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 healthy male volunteers will be invited to participate in the second part of the study. Participants will be randomly assigned to receive a dental anaesthetic solution injection with a microneedle device (Group I) or with a standard thirty-gauge short hypodermic needles (Group II) in the first week of the second part of the study.

Group I: The microneedle device will be applied randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla in order to inject slowly a standard local dental anaesthetic solution.

Group II: A standard thirty-gauge short hypodermic needles will be used for insertion and injection of the same standard local dental anaesthetic solution randomly to the left or right buccal mucosa of the first premolar tooth in the maxilla.

Quantitative and qualitative measurements of the pain experienced and the depth of anaesthesia achieved will be recorded for both groups and compared.

In order to eliminate any carryover effects, a washout period of one week between receiving a second, opposite injection will be applied (i.e. Group I will receive an injection with a standard thirty-gauge short hypodermic needles and Group II an injection with the microneedle device). The buccal mucosa of the first premolar tooth in the untreated, opposite maxilla side will receive an injection with the remaining injection method following the same procedure as described for the first week. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02966067
Study type Interventional
Source University of Dublin, Trinity College
Contact
Status Completed
Phase N/A
Start date September 1, 2017
Completion date December 8, 2017

See also
  Status Clinical Trial Phase
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04513652 - A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution Phase 3
Completed NCT05464862 - The Effect of PPB Using 10, 20 and 30 ml of Lidocaine, Study on Volunteers Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT03245359 - Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks N/A
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT05815563 - Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
Completed NCT01418690 - Changes in Tissue Oxygenation Following Regional Anesthesia N/A
Suspended NCT03291691 - Protective Nerve Stimulation in Regional Anesthesia
Not yet recruiting NCT03545516 - Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery Phase 2
Not yet recruiting NCT05038007 - Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades Phase 2
Terminated NCT03672500 - Perineal Local Infiltration Study N/A
Enrolling by invitation NCT06057090 - Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients? N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Recruiting NCT06011005 - Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel. N/A
Completed NCT04536311 - Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block N/A
Completed NCT03600454 - The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response N/A
Recruiting NCT03159338 - Platelet-rich Fibrin on Nerve Regeneration After Bilateral Sagittal Split Osteotomy N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Recruiting NCT04960046 - A Comparison Between a PC and a CC Approach for the Placement of Infraclavicular Perineural Catheters in Hand Surgery N/A