Introduction: A current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients.
Methods And Analysis: The proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8-12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student's t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size.
Ethics And Dissemination: This study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.
Trial Registration Number: NCT03445182; Pre-results.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609117 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2019-029460 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Multimodal ultrasound assessment of the injection therapy in lateral epicondylitis: a retrospective observational study.
BMC Musculoskelet Disord
January 2025
Orthopedics Department of Zhejiang Rongjun Hospital, Jiaxing City, Zhejiang Province, China.
Background: At present, there is a dearth of objective methodologies for assessing the effectiveness of treatments for Lateral Epicondylitis (LE). This study examined 73 patients suffering from tennis elbow using a multimodal ultrasound approach and investigated the correlation between pertinent indicators and clinical scores.
Methods: 73 patients diagnosed with unilateral tennis elbow by interventional ultrasound at Zhejiang Rongjun Hospital were included in the study.
A ROS-responsive hydrogel encapsulated with matrix metalloproteinase-13 siRNA nanocarriers to attenuate osteoarthritis progression.
J Nanobiotechnology
January 2025
State Key Laboratory of Pharmaceutical Biotechnology, Division of Sports Medicine and Adult Reconstructive Surgery, Department of Orthopedic Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, 321 Zhongshan Road, Nanjing, 210008, People's Republic of China.
RNA interference (RNAi) and oxidative stress inhibition therapeutic strategies have been extensively utilized in the treatment of osteoarthritis (OA), the most prevalent degenerative joint disease. However, the synergistic effects of these approaches on attenuating OA progression remain largely unexplored. In this study, matrix metalloproteinase-13 siRNA (siMMP-13) was incorporated onto polyethylenimine (PEI)-polyethylene glycol (PEG) modified FeO nanoparticles, forming a nucleic acid nanocarrier termed si-Fe NPs.
View Article and Find Full Text PDFOutcomes of Direct Anterior Total Hip Arthroplasty in Patients Who Have Preoperative Gluteal Tendinopathy and Tears: A Propensity-Matched Analysis.
J Arthroplasty
January 2025
Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, U.S.A. Electronic address:
Background: The gluteus medius and minimus muscles play a critical role in hip biomechanics, however there is a paucity of literature examining the impact of preoperative gluteal pathology on outcomes following total hip arthroplasty (THA). This study compared pain, satisfaction, and functional outcomes among patients who had and did not have preoperative gluteal pathology after direct anterior (DA) THA.
Methods: Using an institutional total joint registry, patients undergoing DA THA for osteoarthritis between 2010 and 2022 were retrospectively reviewed.
Intraoperative Facet Joint Block Reduces Pain After Oblique Lumbar Interbody Fusion: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial.
J Bone Joint Surg Am
November 2024
Department of Neurosurgery, Bokwang Hospital, Daegu, Republic of Korea.
Background: Oblique lumbar interbody fusion (OLIF) results in less tissue damage than in other surgeries, but immediate postoperative pain occurs. Notably, facet joint widening occurs in the vertebral body after OLIF. We hypothesized that the application of a facet joint block to the area of widening would relieve facet joint pain.
View Article and Find Full Text PDFSpine-Abductor Syndrome: Novel Associations Between Lumbar Spine Disease and Hip Gluteal Muscle Pathology.
J Bone Joint Surg Am
November 2024
Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio.
Background: Risk factors for gluteal tears include age-related deterioration, female sex, and increased body mass index. As the literature that supports the sagittal relationship between the lumbar spine and the hip is increasing, there may be a parallel relationship between the perturbations in spinopelvic alignment caused by lumbar spine disease and gluteal muscle tears. Because no prior studies other than single-institution series have reported on this phenomenon, we investigated spine-abductor syndrome at the population level.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!