scholarly journals Histological and Histomorphometric Evaluation of Post-Extractive Sites Filled with a New Bone Substitute with or without Autologous Plate Concentrates: One-Year Randomized Controlled Trial

Materials ◽  
2021 ◽  
Vol 15 (1) ◽  
pp. 254
Author(s):  
Marco Tallarico ◽  
Erta Xhanari ◽  
Aurea Maria Immacolata Lumbau ◽  
Adela Alushi ◽  
Irene Ieria ◽  
...  
Keyword(s):  
Tooth Extraction ◽  
Controlled Trial ◽  
Test Group ◽  
Compact Bone ◽  
Control Group ◽  
Socket Preservation ◽  
Randomized Controlled ◽  
The Mean ◽  
The Difference ◽  
One Year

The purpose of the present study was to evaluate the histological and histomorphometric characteristics of post-extraction sites grafted with decellularized bovine compact bone from bovine femur, mixed and unmixed with leukocyte- and platelet-rich fibrin after four months of healing. This study was designed as a randomized controlled trial of parallel groups. Patients in need of a single, implant-supported restoration to replace a hopeless tooth were recruited for tooth extraction and implant placement four months after socket preservation procedure. After tooth extraction, patients were randomly allocated to receive decellularized bovine compact bone from bovine femur, mixed and unmixed with leukocyte- and platelet-rich fibrin. After four months of healing, tapered implants were inserted with an insertion torque between 35 and 45 Ncm. Two months later, implants were loaded with screw-retained definitive crowns. Outcome measures were implant (ISR) and prosthesis (PSR) survival rates, complications, histological and histomorphometric analyses, radiographic marginal bone-level changes, and patients’ satisfaction. Clinical data were collected up to one year after tooth extraction and socket preservation procedures. Thirty patients were consecutively enrolled in the trial (15 in each group). Unfortunately, due to the COVID-19 pandemic, bone samples were collected only in 19 patients. Two implants failed before definitive prosthesis delivery (ISR 93.3%). No prosthesis failed (PSR 100%). Three complications were experienced in the control group. The mean bone percentage was 40.64 ± 18.76 in the test group and 33.40 ± 22.38 in the control group. The difference was not statistically significant (p = 0.4846). The mean soft tissue percentage was 32.55 ± 19.45 in the test group and 55.23 ± 17.64 in the control group. The difference was statistically significant (p = 0.0235). The mean residual graft was 24.59 ± 18.39 in the test group and 11.37 ± 12.12 in the control group. The difference was not statistically significant (p = 0.0992). Mean marginal bone loss, as well as patient satisfaction, showed no differences between groups. With the limitations of the present study, socket preservation with L-PRF mixed with decellularized bovine compact bone demonstrated favorable results, comparing with decellularized bovine compact bone from bovine femur alone. Further studies with larger sample size and longer follow-up are needed to confirm these preliminary results.

scholarly journals The Influence of Local Pamidronate Application on Alveolar Dimensional Preservation after Tooth Extraction—An Animal Experimental Study

2020 ◽  
Vol 21 (10) ◽  
pp. 3616
Author(s):  
Frederic Kauffmann ◽  
Christian Höhne ◽  
Alexandre Thomas Assaf ◽  
Tobias Vollkommer ◽  
Jan Semmusch ◽  
...  
Keyword(s):  
Tooth Extraction ◽  
Test Group ◽  
Control Group ◽  
Local Inflammation ◽  
Socket Preservation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Bone Substitute Materials ◽  
Animal Experimental Study ◽  
Substitute Materials

The aim of this randomized, controlled animal exploratory trial was to investigate the influence of local application of aminobisphosphonate pamidronate during the socket preservation procedure. Mandibular premolars were extracted in five Göttingen minipigs. Two animals underwent socket preservation using BEGO OSS (n = 8 sockets) and three animals using BEGO OSS + Pamifos (15 mg) (n = 12 sockets). After jaw impression, cast models (baseline, eight weeks postoperative) were digitized using an inLab X5 scanner (Dentsply Sirona) and the generated STL data were superimposed and analyzed with GOM Inspect 2018 (GOM, Braunschweig). After 16 weeks, the lower jaws were prepared and examined using standard histological methods. In the test group (BEGO OSS + pamidronate), buccooral dimensional loss was significantly lower, both vestibulary (−0.80 ± 0.57 mm vs. −1.92 ± 0.63 mm; p = 0.00298) and lingually (−1.36 ± 0.58 mm vs. −2.56 ± 0.65 mm; p = 0.00104) compared with the control group (BEGO OSS). The test group showed a significant difference between vestibular and lingual dimensional loss (p = 0.04036). Histology showed cortical and cancellous bone in the alveolar sockets without signs of local inflammation. Adjuvant application of pamidronate during socket preservation reduces alveolar dimensional loss significantly. Further investigations with regard to dose–response relationships, volume effects, side effects, and a verification of the suitability in combination with other bone substitute materials (BSMs) are necessary.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Asieh Mehdipour ◽  
Parvin Abedi ◽  
Somayeh Ansari ◽  
Maryam Dastoorpoor
Keyword(s):  
Randomized Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Moderate Depression ◽  
Before And After ◽  
The Mean ◽  
And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

scholarly journals Randomized controlled study comparing 2 surgical techniques for decompressive craniectomy: with watertight duraplasty and without watertight duraplasty

2018 ◽  
Vol 129 (4) ◽  
pp. 1017-1023 ◽  
Author(s):  
Eduardo Vieira ◽  
Thiago C. Guimarães ◽  
Igor V. Faquini ◽  
Jose L. Silva ◽  
Tammy Saboia ◽  
...  
Keyword(s):  
Wound Infection ◽  
Decompressive Craniectomy ◽  
Surgical Complications ◽  
Test Group ◽  
Csf Leak ◽  
Control Group ◽  
Surgical Time ◽  
Randomized Controlled ◽  
The Mean ◽  
Fluid Collections

OBJECTIVEDecompressive craniectomy (DC) is a widely used procedure in neurosurgery; however, few studies focus on the best surgical technique for the procedure. The authors’ objective was to conduct a prospective randomized controlled trial comparing 2 techniques for performing DC: with watertight duraplasty and without watertight duraplasty (rapid-closure DC).METHODSThe study population comprised patients ranging in age from 18 to 60 years who were admitted to the Neurotrauma Service of the Hospital da Restauração with a clinical indication for unilateral decompressive craniectomy. Patients were randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group) and without watertight duraplasty (test group). After unilateral DC was completed, watertight duraplasty was performed in the control group, while in the test group, no watertight duraplasty was performed and the exposed parenchyma was covered with Surgicel and the remaining dura mater. Patients were then monitored daily from the date of surgery until hospital discharge or death. The primary end point was the incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections). The following were analyzed as secondary end points: clinical outcome (analyzed using the Glasgow Outcome Scale [GOS]), surgical time, and hospital costs.RESULTSFifty-eight patients were enrolled, 29 in each group. Three patients were excluded, leaving 27 in the test group and 28 in the control group. There were no significant differences between groups regarding age, Glasgow Coma Scale score at the time of surgery, GOS score, and number of postoperative follow-up days. There were 9 surgical complications (5 in the control group and 4 in the test group), with no significant differences between the groups. The mean surgical time in the control group was 132 minutes, while in the test group the average surgical time was 101 minutes, a difference of 31 minutes (p = 0.001). The mean reduction in total cost was $420.00 USD (a 23.4% reduction) per procedure in the test group.CONCLUSIONSRapid-closure DC without watertight duraplasty is a safe procedure. It is not associated with a higher incidence of surgical complications (CSF leak, wound infection, brain abscess, or subgaleal fluid collections), and it decreased surgical time by 31 minutes on average. There was also a hospital cost reduction of $420.00 USD (23.4% reduction) per procedure.Clinical trial registration no.: NCT02594137 (clinicaltrials.gov)

scholarly journals A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

2020 ◽  
Vol 9 (5) ◽  
pp. 1976
Author(s):  
Rahul Kirtania ◽  
Jayita Pal ◽  
Sisir Biswas ◽  
Aditi Aich
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Active Management ◽  
Control Group ◽  
Care Hospital ◽  
Normal Delivery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

Citation Advantage of Promoted Articles in a Cross-Publisher Distribution Platform: 36-month Follow-up to a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Paul Kudlow ◽  
Tashauna Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Tool ◽  
Randomized Controlled ◽  
Subject Areas ◽  
The Subject ◽  
The Difference ◽  
Citation Advantage

BACKGROUND There are limited evidence-based strategies that have been shown to increase the rate at which peer-reviewed articles are cited. In a previously reported randomized controlled trial we demonstrated that promotion of article links in an online cross-publisher distribution platform (TrendMD) persistently augments citation rates after 12 months, leading to a statistically significant, 50% increase in citations relative to control. OBJECTIVE To investigate if the citation advantage of promoted articles upholds after 36-months. METHODS Three thousand two hundred articles published in 64 peer-reviewed journals across eight subject areas were block randomized at the subject level to either the TrendMD group (n=1600) or the control group (n=1600) of the study. Articles were promoted in the TrendMD Network for 6 months. We compared the citation rates in both groups after 36 months. RESULTS At 36 months, we found the citation advantage endured; articles randomized to TrendMD showed a 28% increase in mean citations relative to control. The difference in mean citations at 36 months for articles randomized to TrendMD versus control was 10.52, 95% CI [3.79, 17.25] and was statistically significant (p=0.001). CONCLUSIONS To our knowledge, this is the first randomized controlled trial to demonstrate how a post-publication article promotion intervention can be used to persistently augment citations of peer-reviewed articles. TrendMD is an efficient digital tool for knowledge translation and dissemination to targeted audiences to facilitate uptake of research.

Abstract P034: The Effectiveness of 12-week Tai Chi Training on the Migraine Attack Days, Body Composition, and Blood Pressure in Chinese Women With Episodic Migraine: A Randomized Controlled Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Yao Jie Xie ◽  
Stanley Sai-chuen Hui ◽  
Suzanne C. Ho ◽  
Lorna Kwai Ping Suen
Keyword(s):  
Blood Pressure ◽  
Migraine Attack ◽  
Body Fat ◽  
Tai Chi ◽  
Chinese Women ◽  
Controlled Trial ◽  
Episodic Migraine ◽  
Control Group ◽  
Randomized Controlled ◽  
The Difference

Background: Tai Chi is a body-mind exercise. It’s prophylactic efficacy on migraine attack remains largely unknown. The purpose of this study was to examine the effect of a 12-week Tai Chi training on the migraine attack days per month, body composition, and blood pressure (BP) in a sample of Chinese women with episodic migraine. Method: A two-arm randomized controlled trial was designed. Eighty-two local women aged 18 to 65 years and diagnosed with episodic migraine were randomized to the Tai Chi group or the waiting list control group. A modified 32-short form Yang-style Tai Chi training with 1 hour per day, 5 days per week for 12 weeks was adopted as intervention. An additional 12 weeks follow was conducted. The control group received a “delayed” Tai Chi training at the end of the trial. The difference in migraine days between 1 month before baseline, 3rd month (12nd week) and 6th month (24th week) after the randomization were examined. The changes in weight, body fat, and BP before and after the intervention were also analyzed. Results: Of 189 women screened, 82 eligible women completed the baseline assessment. After randomization, 9 women withdrew immediately, finally 40 in Tai Chi group and 33 in control group were involved in the analysis. On average, women in Tai Chi group had 3.6 (95% CI: -4.7 to -2.5, P<0.01) days reduction of migraine attack. Compared with control group, the difference was statistically significant (P<0.001). Tai Chi group also lost 0.6 kg of body weight and 0.6% of body fat at the 3rd month, and 10.8 mmHg systolic BP at the 6th month, respectively (all p<0.001). The between-group difference of systolic BP was -6.9 mmHg (95% CI: -11.6 mmHg to -2.1mmHg, p<0.05), whereas no significant differences were observed regarding weight and body fat at the 3rd month (all p>0.05). Among Tai Chi group, change in systolic BP was significantly correlated to the change in migraine days (P<0.05). Conclusion: The 12-week Tai Chi training significantly decreased the frequency of migraine attack and improved the systolic BP. The association between migraine attack reduction and BP improvement needs further investigations.

Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial

2020 ◽  
Vol 99 (4) ◽  
pp. 402-409 ◽  
Author(s):  
G. Avila-Ortiz ◽  
M. Gubler ◽  
M. Romero-Bustillos ◽  
C.L. Nicholas ◽  
M.B. Zimmerman ◽  
...  
Keyword(s):  
Tooth Extraction ◽  
Alveolar Bone ◽  
Controlled Trial ◽  
Control Group ◽  
Ridge Preservation ◽  
Alveolar Ridge ◽  
Bone Augmentation ◽  
Randomized Controlled ◽  
Implant Placement ◽  
Alveolar Ridge Preservation

Alveolar ridge preservation (ARP) therapy is indicated to attenuate the physiologic resorptive events that occur as a consequence of tooth extraction with the purpose of facilitating tooth replacement therapy. This randomized controlled trial was primarily aimed at testing the efficacy of ARP as compared with unassisted socket healing. A secondary objective was to evaluate the effect that local phenotypic factors play in the volumetric reduction of the alveolar bone. A total of 53 subjects completed the study. Subjects were randomized into either the control group, which involved only tooth extraction (EXT n = 27), or the experimental group, which received ARP using a combination of socket grafting with a particulate bone allograft and socket sealing with a nonabsorbable membrane (dPTFE) following tooth extraction (ARP n = 26). A set of clinical, linear, volumetric, implant-related, and patient-reported outcomes were assessed during a 14-wk healing period. All linear bone assessments (horizontal, midbuccal, and midlingual reduction) revealed that ARP is superior to EXT. Likewise, volumetric bone resorption was significantly higher in the control group (mean ± SD: EXT = −15.83% ± 4.48%, ARP = −8.36% ± 3.81%, P < 0.0001). Linear regression analyses revealed that baseline buccal bone thickness is a strong predictor of alveolar bone resorption in both groups. Interestingly, no significant differences in terms of soft tissue contour change were observed between groups. Additional bone augmentation to facilitate implant placement in a prosthetically acceptable position was deemed necessary in 48.1% of the EXT sites and only 11.5% of the ARP sites ( P < 0.004). Assessment of perceived postoperative discomfort at each follow-up visit revealed a progressive decrease over time, which was comparable between groups. Although some extent of alveolar ridge remodeling occurred in both groups, ARP therapy was superior to EXT as it was more efficacious in the maintenance of alveolar bone and reduced the estimated need for additional bone augmentation at the time of implant placement (ClinicalTrials.gov NCT01794806).

scholarly journals Effectiveness of a family-centered behavioral and educational counselling approach to improve periodontal health of pregnant women: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Pei Liu ◽  
Weiye Wen ◽  
Ka Fung Yu ◽  
Xiaoli Gao ◽  
Edward Chin Man Lo ◽  
...  
Keyword(s):  
Oral Health ◽  
Pregnant Women ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Test Group ◽  
Control Group ◽  
Oral Health Promotion ◽  
Periodontal Health ◽  
The Mean ◽  
Family Centered

Abstract Background Poor oral hygiene and high hormone levels during pregnancy can lead to a deterioration in periodontal health. This study assessed the effectiveness of a family-centered behavioral and educational counselling program on improving the periodontal health of women during pregnancy and postpartum. Methods A randomized controlled trial was conducted among pregnant women (10th-22nd gestational week) and their husbands. Participating families were randomized into test and control groups. Intervention in the test group included explanation of oral health education (OHE) pamphlets, oral hygiene instruction, individualized feedback, and proposed solutions to overcome barriers in self-care. Reinforcements were implemented in the 3rd trimester of pregnancy and six months postpartum. In the control group, only OHE pamphlets were distributed. The assessed outcomes were bleeding on probing (BOP), periodontal pocket (Poc), loss of clinical attachment (LoA), and Visible Plaque Index (VPI). The data collection was carried out at baseline (T0), in the 32nd gestational week (T1), and 12 months postpartum (T2). Results Altogether 589 pregnant women were recruited, and 369 attended all three visits (test:188; control:181). In the test group, the mean VPI score at T0 was 0.19, which decreased to 0.14 at T1 and 0.15 at T2. In the control group, the mean VPI decreased from 0.19 at T0 to 0.16 at T1, but increased to 0.22 at T2. A main effect of time and intervention and an interaction between time and intervention were detected (all p < 0.05), indicating that the intervention effect differed between T1 and T2. The test group showed a significantly greater decrease over time than the control group did. Similarly, the mean BOP% decreased more significantly over time in the test group (T0:57%, T1:46%, T2:35%) than in the control group (T0:58%, T1:52%, T2:46%). For Poc and LoA, there were improvements in both study groups at 12 months postpartum, compared with during pregnancy (p < 0.001). Conclusions Providing family-centered, behavioral, and educational counselling to pregnant women at an early stage of pregnancy and with reinforcements can improve their oral hygiene and reduce gingival inflammation. The effect can be sustained over an extended period and is greater than that of distributing oral health leaflets alone. Trial registration Clinicaltrials.gov, #NCT02937194. Registered 18 October 2016. Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02937194?cond=Family-centered+oral+health+promotion+for+new+parents+and+their+infants&draw=2&rank=1

Piezocision-assisted orthodontic treatment using CAD/CAM customized orthodontic appliances: a randomized controlled trial in adults

2019 ◽  
Vol 41 (5) ◽  
pp. 495-501 ◽  
Author(s):  
Carole Charavet ◽  
Geoffrey Lecloux ◽  
Nastasia Jackers ◽  
Adelin Albert ◽  
France Lambert
Keyword(s):  
Orthodontic Treatment ◽  
Treatment Time ◽  
Controlled Trial ◽  
Test Group ◽  
University Hospital ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Overall Treatment Time ◽  
Randomized Controlled ◽  
Cad Cam

Summary Objective The aim of this study was to investigate the effects of piezocision (surgical protocol with sutures) in orthodontic treatment using CAD/CAM (computer-aided design and computer-aided manufacturing) customized orthodontic appliances. Design The study is designed as a parallel group, randomized controlled trial (RCT). Setting University Hospital. Ethical approval The study was approved by the ethic committee of the University Hospital Liege, Belgium. Subjects and methods This RCT was conducted on 24 adult patients requiring orthodontic treatment to release mild overcrowding. Patients were all treated with a customized appliance and randomly assigned by means of sealed envelopes containing group codes to either a test group treated with piezocision or a control group without any further treatment. A blinded orthodontist validated appliance removal or further adjustments based on the model study. Outcome measures The overall treatment time and the time between archwire changes were recorded. Moreover, clinical and radiological features such as tooth resorption, gingival recessions, and the presence of scars were evaluated. Results A total of 24 patients (12 control and 12 test) completed the study. The overall treatment time was significantly shorter in the test group than the control group. Likewise, the time difference between all arch changes was significantly lower when piezocision was performed, except for the first arch at the mandible and the last arches at both maxillae. During the fine-tuning phase, no significant difference was found between the two groups. All periodontal and radiographic parameters remained stable from the start to the end of treatment in both the groups. However, minor scars were found in 66 per cent cases. Limitations This trial was a single-centre trial. Conclusions Piezocision seems to be an effective method to accelerate orthodontic treatment in cases of mild overcrowding. However, the effect was only observed during the alignment phase and a greater efficiency was found in the maxilla. The technique may be contraindicated in patients with a high smile line since the risk of slight scarring exists. Registration ClinicalTrails.gov (Identifier: NCT03406130)

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