A comparative assessment of transfer accuracy of two indirect bonding techniques in patients undergoing fixed mechanotherapy: A randomised clinical trial

2020 ◽  
pp. 146531252096857
Author(s):  
Vivek Chaudhary ◽  
Puneet Batra ◽  
Karan Sharma ◽  
Sreevatsan Raghavan ◽  
Vikram Gandhi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Previous History ◽  
Three Dimensional ◽  
Randomised Clinical Trial ◽  
Vertical Dimension ◽  
Indirect Bonding ◽  
Transfer Error ◽  
3D Printed ◽  
Randomised Controlled ◽  
Transfer Accuracy

Objectives To assess the transfer accuracy of three-dimensional (3D) printed transfer trays and compare them with transfer trays made up of polyvinyl siloxane (PVS) for use in indirect bonding. Design: This was a two-arm parallel prospective randomised controlled trial. Setting: The trial was undertaken at the outpatient department of a dental college. Participants: A total of 30 patients (18 men, 12 women) were randomly allocated to two groups. Methods: The inclusion criteria included patients with permanent and fully erupted dentition (age range = 17–24 years), Angles class I malocclusion with crowding <3 mm requiring non-extraction treatment, good oral hygiene and no previous history of orthodontic treatment. Blinding was applicable only for outcome assessment. Indirect bonding was performed by the primary investigator for both the groups. Digital images of the pre-transfer and post-transfer brackets were obtained by means of an intra-oral scanner and compared using software. Superimpositions of pre- and post-transfer images were done to determine the transfer error for linear and angular variables for all tooth types. Results: A total of 600 teeth were bonded, 300 each for both groups. Statistically significant differences were observed in all dimension between the two groups, with 3D-printed trays being more accurate than PVS trays except in the vertical dimension ( P < 0.05). The prevalence of clinically unacceptable transfer errors revealed that most of the transfer errors were in the vertical dimensions for 3D-printed trays. Conclusion: 3D-printed trays are more accurate than PVS trays except for transfers in vertical dimension.

scholarly journals Comparison of the transfer accuracy of two digital indirect bonding trays for labial bracket bonding

2020 ◽  
Vol 91 (1) ◽  
pp. 67-73
Author(s):  
Ye Niu ◽  
Yunting Zeng ◽  
Zeyu Zhang ◽  
Wanghan Xu ◽  
Liwei Xiao
Keyword(s):  
Three Dimensional ◽  
Scanning System ◽  
Chi Square ◽  
Directional Bias ◽  
Bonding System ◽  
Indirect Bonding ◽  
Transfer Error ◽  
Chi Square Test ◽  
3D Printed ◽  
Transfer Accuracy

ABSTRACT Objectives To compare the transfer accuracy of two digital transfer trays, the three-dimensional printed (3D printed) tray and the vacuum-formed tray, in the indirect bonding of labial brackets. Materials and Methods Ten digital dental models were constructed by oral scans using an optical scanning system. 3D printed trays and vacuum-formed trays were obtained through the 3Shape indirect bonding system and rapid prototyping technology (10 in each group). Then labial brackets were transferred to 3D printed models, and the models with final bracket positioning were scanned. Linear (mesiodistal, vertical, buccolingual) and angular (angulation, torque, rotation) transfer errors were measured using GOM Inspect software. The mean transfer errors and prevalence of clinically acceptable errors (linear errors of ≤0.5 mm and angular errors of ≤2°) of two digital trays were compared using the Mann-Whitney U-test and the Chi-square test, respectively. Results The 3D printed tray had a lower mean mesiodistal transfer error (P &lt; .01) and a higher prevalence of rotation error within the limit of 2° (P = .03) than did the vacuum-formed tray. Linear errors within 0.5 mm were higher than 90% for both groups, while torque errors within 2° were lowest at 50.9% and 52.9% for the 3D printed tray and vacuum-formed tray, respectively. Both groups had a directional bias toward the occlusal, mesial, and buccal. Conclusions The 3D printed tray generally scored better in terms of transfer accuracy than did the vacuum-formed tray. Both types of trays had better linear control than angular control of brackets.

scholarly journals 3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038373
Author(s):  
Youyu Zhang ◽  
Junyang Liang ◽  
Nanfang Xu ◽  
Lin Zeng ◽  
Chaojun Du ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adolescent Idiopathic Scoliosis ◽  
Idiopathic Scoliosis ◽  
Cobb Angle ◽  
Sample Size ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Three Dimensional ◽  
3D Printed ◽  
Randomised Controlled

IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.

scholarly journals Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041129
Author(s):  
Lawrence Chun Man Lau ◽  
Elvis Chun Sing Chui ◽  
Jason Chi Ho Fan ◽  
Gene Chi Wai Man ◽  
Yuk Wah Hung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
High Tibial Osteotomy ◽  
Controlled Trial ◽  
Patient Specific ◽  
Tibial Osteotomy ◽  
Double Blind ◽  
Patient Specific Instrumentation ◽  
3D Printed ◽  
Randomised Controlled

IntroductionHigh tibial osteotomy (HTO) is a treatment of choice for active adult with knee osteoarthritis. With advancement in CT imaging with three-dimensional (3D) model reconstruction, virtual planning and 3D printing, patient-specific instrumentation (PSI) in form of cutting jigs is employed to improve surgical accuracy and outcome of HTO. The aim of this randomised controlled trial (RCT) is to explore the surgical outcomes of HTO for the treatment of medial compartment knee osteoarthritis with or without a 3D printed patient-specific jig.Methods and analysisA double-blind RCT will be conducted with patients and outcome assessors blinded to treatment allocation. This meant that neither the patients nor the outcome assessors would know the actual treatment allocated during the trial. Thirty-six patients with symptomatic medial compartment knee osteoarthritis fulfilling our inclusion criteria will be invited to participate the study. Participants will be randomly allocated to one of two groups (1:1 ratio): operation with 3D printed patient-specific jig or operation without jig. Measurements will be taken before surgery (baseline) and at postoperatively (6, 12 and 24 months). The primary outcome includes radiological accuracy of osteotomy. Secondary outcomes include a change in knee function from baseline to postoperatively as measured by three questionnaires: Knee Society Scores (Knee Scores and Functional Scores), Oxford Knee Scores and pain visual analogue scale (VAS) score.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (CREC no. 2019.050), in accordance with the Declaration of Helsinki. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numberNCT04000672; Pre-results.

scholarly journals Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

2021 ◽  
Vol 8 (1) ◽  
pp. e000562
Author(s):  
Adriana Fabiola Romano-Munive ◽  
J Jesus García-Correa ◽  
Luis F García-Contreras ◽  
José Ramírez-García ◽  
Luis Uscanga ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Sterile Water ◽  
Endoscopic Retrograde ◽  
Double Blind ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

scholarly journals A skin cancer prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e018299 ◽  
Author(s):  
Titus Josef Brinker ◽  
Bianca Lisa Faria ◽  
Martina Gatzka ◽  
Olber Moreira de Faria ◽  
Markus V Heppt ◽  
...  
Keyword(s):  
Skin Cancer ◽  
Cancer Prevention ◽  
Controlled Trial ◽  
Three Dimensional ◽  
Mobile App ◽  
Skin Cancer Prevention ◽  
Sunscreen Use ◽  
Novel Method ◽  
Randomised Controlled

IntroductionThe incidence of melanoma is increasing faster than any other major cancer both in Brazil and worldwide. The Southeast of Brazil has especially high incidences of melanoma, and early detection is low. Exposure to UV radiation represents a primary risk factor for developing melanoma. Increasing attractiveness is a major motivation for adolescents for tanning. A medical student-delivered intervention that harnesses the broad availability of mobile phones as well as adolescents’ interest in their appearance may represent a novel method to improve skin cancer prevention.Methods and analysisWe developed a free mobile app (Sunface), which will be implemented in at least 30 secondary school classes, each with 21 students (at least 30 classes with 21 students for control) in February 2018 in Southeast Brazil via a novel method called mirroring. In a 45 min classroom seminar, the students’ altered three-dimensional selfies on tablets are ‘mirrored’ via a projector in front of their entire class, showing the effects of unprotected UV exposure on their future faces. External block randomisation via computer is performed on the class level with a 1:1 allocation. Sociodemographic data, as well as skin type, ancestry, UV protection behaviour and its predictors are measured via a paper–pencil questionnaire before as well as at 3 and 6 months postintervention. The primary end point is the group difference in the 30-day prevalence of daily sunscreen use at a 6-month follow-up. Secondary end points include (1) the difference in daily sunscreen use at a 3-month follow-up, (2) if a self-skin examination in accordance with the ABCDE rule was performed within the 6-month follow-up and (3) the number of tanning sessions.Ethics and disseminationEthical approval was obtained from the ethics committee of the University of Itauna. Results will be disseminated at conferences and in peer-reviewed journals.Trial registration numberNCT03178240; Pre-results.

Immediate Effect of Scalp Acupuncture on the Gait of Patients with Subacute Intracerebral Haemorrhage Analysed by Three-Dimensional Motion: Secondary Analysis of a Randomised Controlled Trial

2018 ◽  
Vol 36 (2) ◽  
pp. 71-79 ◽  
Author(s):  
Hai-Qiao Wang ◽  
Gui-Rong Dong ◽  
Chun-Ling Bao ◽  
Zhi-Hua Jiao
Keyword(s):  
Treatment Group ◽  
Acupuncture Treatment ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Three Dimensional ◽  
Scalp Acupuncture ◽  
Control Group ◽  
Kinematic Parameters ◽  
Spatiotemporal Parameters ◽  
Randomised Controlled

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.

scholarly journals Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036327 ◽  
Author(s):  
Belay Bayissasse ◽  
Kristin M Sullivan ◽  
Shannath L Merbs ◽  
Beatriz Munoz ◽  
Alexander Keil ◽  
...  
Keyword(s):  
Surgical Outcomes ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Upper Eyelid ◽  
Intention To Treat ◽  
Research Ethics Review ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Impact ◽  
Trachomatous Trichiasis

IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.

scholarly journals Bracket transfer accuracy with two different three-dimensional printed transfer trays vs silicone transfer trays

2022 ◽  
Author(s):  
Lea Hoffmann ◽  
Hisham Sabbagh ◽  
Andera Wichelhaus ◽  
Andreas Kessler
Keyword(s):  
Three Dimensional ◽  
Processing System ◽  
Similar Distribution ◽  
Digital Light Processing ◽  
Directional Bias ◽  
Indirect Bonding ◽  
Significant Difference ◽  
Transfer Tray ◽  
Transfer Accuracy ◽  
Bracket Positioning

ABSTRACT Objectives To compare the transfer accuracy of two different three-dimensional printed trays (Dreve FotoDent ITB [Dreve Dentamid, Unna, Germany] and NextDent Ortho ITB [NextDent, Soesterberg, the Netherlands]) to polyvinyl siloxane (PVS) trays for indirect bonding. Materials and Methods A total of 10 dental models were constructed for each investigated material. Virtual bracket placement was performed on a scanned dental model using OnyxCeph (OnyxCeph 3D Lab, Chemnitz, Germany). Three-dimensional printed transfer trays using a digital light processing system three-dimensional printer and silicone transfer trays were produced. Bracket positions were scanned after the indirect bonding procedure. Linear and angular transfer errors were measured. Significant differences between mean transfer errors and frequency of clinically acceptable errors (&lt;0.25 mm/1°) were analyzed using the Kruskal–Wallis and χ2 tests, respectively. Results All trays showed comparable accuracy of bracket placement. NextDent exhibited a significantly higher frequency of rotational error within the limit of 1° (P = .01) compared with the PVS tray. Although PVS showed significant differences between the tooth groups in all linear dimensions, Dreve exhibited a significant difference in the buccolingual direction only. All groups showed a similar distribution of directional bias. Conclusions Three-dimensional printed trays achieved comparable results with the PVS trays in terms of bracket positioning accuracy. NextDent appears to be inferior compared with PVS regarding the frequency of clinically acceptable errors, whereas Dreve was found to be equal. The influence of tooth groups on the accuracy of bracket positioning may be reduced by using an appropriate three-dimensional printed transfer tray (Dreve).

scholarly journals A randomised clinical trial of ultrasound guided cannulation of difficult fistulae for dialysis access

2020 ◽  
pp. 112972982095472
Author(s):  
Joshua Eves ◽  
Paris Cai ◽  
Ross Latham ◽  
Clement Leung ◽  
Daniel Carradice ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Ultrasound Guidance ◽  
Controlled Trial ◽  
Standard Technique ◽  
Randomised Clinical Trial ◽  
Dialysis Access ◽  
Complication Rates ◽  
Ultrasound Guided ◽  
Prolonged Time ◽  
Randomised Controlled

Background: Arteriovenous fistulae (AVF) are preferred for dialysis access but require accurate cannulation for effective dialysis. Evidence supports improvements in cannulation and complication rates using ultrasound guidance (USG) in cannulating other sites. This mixed methods, randomised controlled trial aimed to assess effects of USG during AVF cannulation. Methods: Participants with difficult to cannulate AVF had each cannulation event randomised to USG or standard technique (no USG). The primary outcome was the incidence and number of additional needle passes. Secondary outcomes included: the incidence and number of additional skin punctures; time to achieve two needle cannulation; pain associated with cannulation; local complications. Qualitative outcomes were assessed using patient and staff questionnaires. Results: Thirty-two participants had 346 cannulation events randomised (170 to USG and 176 to standard cannulation). USG resulted in a significant reduction in additional needle passes (72 vs 99 p = 0.007) and additional skin punctures (10 vs 25 p = 0.016.) but prolonged time to cannulation ( p > 0.001). There was no difference in pain score ( p = 0.705) or complications between groups. Questionnaires demonstrated that USG cannulation is acceptable to patients and staff. Conclusion: USG cannulation of AVF is more accurate and no more painful than non-image guided cannulation, but prolonged time to cannulation. Some of the excess time involved may be due to the trial being performed early in cannulating staff’s learning curve with the USG technique. Further work to elucidate which patients gain most benefit from USG cannulation and the effect of USG on cannulation complications and AVF patency is warranted.

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