Trial reportInternational journal of pharmaceutics2021
A crossover clinical study to evaluate pain intensity from microneedle insertion in different parts of the oral cavity.
Trial report in International journal of pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 35 citations in OpenAlex.
- Micro-Needle Assisted Transmucosal Delivery of Triamcinolone and Hyaluronic Acid for the Treatment of Oral Lichen Planus: A Randomized Clinical Trial.Oral diseases · 2026Trial
- Microneedles enhance the efficacy of topical dental anesthesia in male subjects: a randomized controlled trial.Brazilian oral research · 2026Trial
- Review
- [Oral mucosal administration].Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2026Article
- Combined electrospun fibre-microneedle patches for enhanced transmucosal delivery of benzodiazepines and proteins.Biomaterials science · 2026Article
- Core-shell microneedles with MMP/pH-triggered release for periodontitis bone repair.Journal of nanobiotechnology · 2026Article
- Advances in the treatment of recurrent aphthous stomatitis: from synthetic and natural drugs to novel drug delivery systems.Frontiers in pharmacology · 2026Review
- Harnessing Polymeric Dissolvable Microneedles: Precision Delivery of Therapeutics for Oral Ulcers.ACS omega · 2025Review
- Sublingual and Buccal Delivery: A Historical and Scientific Prescriptive.Pharmaceutics · 2025Review
- Biodegradable polymeric insulin microneedles - a design and materials perspective review.Drug delivery · 2024Review
- Multifunctional polysaccharide composited microneedle for oral ulcers healing.Materials today. Bio · 2023Article
- Safety tests and clinical research on buccal and nasal microneedle swabs for genomic analysis.Frontiers in bioengineering and biotechnology · 2023Article
- Polymeric Biomaterials for Topical Drug Delivery in the Oral Cavity: Advances on Devices and Manufacturing Technologies.Pharmaceutics · 2022Review
- Lidocaine-Loaded Hyaluronic Acid Adhesive Microneedle Patch for Oral Mucosal Topical Anesthesia.Pharmaceutics · 2022Article
- Patient centered comparative evaluation of injectable platelet concentrate with or without micro-needling in the management of thin gingival phenotype: A randomized clinical trial.Journal of oral biology and craniofacial researchArticle
- Clinical and patient-reported outcomes of microneedling with ascorbic acid versus scalpel technique for gingival depigmentation: A randomized clinical trial.Journal of oral biology and craniofacial researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
Abstract
The objective of the present study was to evaluate discomfort and safety of microneedle (MN) insertion in several intraoral regions. A device was developed to standardize MN insertions. MNs were inserted in the following regions of the oral cavity: gingiva, palatine alveolar process, buccal mucosa, dorsum of the tongue and inner portion of the lower lip. Perforations from MNs post insertion were confirmed with topical gentian violet stain. Pain was evaluated in a randomized, double-blinded, crossover study in 30 volunteers. Each volunteer received a MN patch, a 30G hypodermic needle (positive control) and an identical MN patch with its needles laying flat in the plane of the patch (negative control). Adverse events were visually evaluated immediately after (0 h) and 24 h post MN application. The application device developed a consistent application force (10 N) and promoted perforation of all individual MNs on a patch. At all sites, insertion of the hypodermic needle promoted more pain when compared to the negative control (p < 0.001). Application of the MNs promoted less pain than the hypodermic needle (p < 0.05), but slightly more pain as compared to the negative control (p < 0.05) at all sites except the tongue, where the MN did not differ from the negative control (p > 0.05). Hypodermic needle caused bleeding at all insertion sites. In contrast, MNs did not cause bleeding at most sites except in some cases of insertion into the hard gingiva and the palatine alveolar process where tiny blood spots appeared immediately after MN application for few of the MNs on the patch. There were no cases of bleeding at 24 h post MN application. In conclusion, MNs can perforate different sites of the oral cavity in a safe and significantly less painful manner as compared to the 30G hypodermic needle. Thus, analogous to the skin, MN-based approaches could be an attractive approach for drug delivery in the oral cavity.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.