Effectiveness of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Video-Assisted Thoracoscopic Lobectomy: A Randomized Controlled Trial

Abstract Background: Postoperative cognitive dysfunction (POCD) is the decline in cognitive ability that occurs between one week and one year following surgery. POCD has been reported to occur in 5% to 26% of elderly surgical patients and its incidence varies with demographic, clinical, and surgical variables. Previous studies have shown that dexmedetomindine (DEX), a highly selective α2 adrenergic receptor agonist, has many effects that include opioid-sparing properties, decreased required anesthetic medication, and neuroprotection in animal models. Ultimately, DEX may benefit cognitive ability in the postoperative period. Therefore, we hypothesized that intraoperative infusion of DEX would reduce early POCD and interleukin-6 (IL-6) levels in elderly surgical patients compared to placebo. Methods: This randomized, double-blind, controlled trial enrolled 96 elderly patients that underwent video-assisted thoracoscopic lobectomy (VATL) between May 2017 and April 2018. The enrolled subjects were randomly assigned in a 1:1 ratio to receive intravenous dexmedetomidine (DEX Group) or placebo (0.9% normal saline, Saline Group) as a continuous infusion at a rate of 0.5μg/kg/hr starting at anesthesia induction until incision closure. All subjects received total intravenous anesthesia (TIVA) during surgery and patient controlled epidural analgesia (PCEA) following surgery. The primary outcomes were to determine the incidence of POCD and IL-6 expression at postoperative day (POD) 1, 2, and 7. The secondary outcomes were to evaluate the degree of pain on POD 1 and 2, as well as adverse events throughout the study. Results: 96 eligible subjects (48 per group) were randomized, dosed with study medication, and evaluated per protocol. There was a significant difference on POCD between the DEX and saline groups on POD 1 (6.3% vs. 20.8%, p-value <0.05) and POD 2 (4.2% vs. 16.7%, p-value <0.05). The IL-6 levels were significantly lower in the DEX group when compared with saline group during POD 1 and 2 (p-value <0.05). IL-6 returned to baseline levels on POD 7. There was no significant difference in POCD on POD7, and overall there were no significant differences in the incidence of adverse events between both groups.Conclusions: The administration of intraoperative DEX in elderly patients undergoing VATL decreased the incidence of early POCD. Clinical Trial Registry: This study was registered on Chinese Clinical Trial Registry with the ID ChiCTR-IPR-17010958.

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A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

10.21203/rs.3.rs-505070/v1 ◽

2021 ◽

Author(s):

Xingqu Chen ◽

Linji Li ◽

Li Yang ◽

Aijiao Li ◽

Miao Wu ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Delirium ◽

Controlled Trial ◽

Randomised Trial ◽

Postoperative Cognitive Dysfunction ◽

Control Group ◽

Neurocognitive Disorder ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Significant Difference

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD).Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P＜0.001, at 7th day) (1% vs 21.1%, P＜0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P＜0.001). The postoperative hospitalisation time （9.99 vs 12.41, P＜0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463. http://www.chictr.org.cn/showproj.aspx?proj=33065

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A Randomised Trial: BIS-Guided Anesthesia Decreases The Incidence of Delayed Neurocognitive Recovery And Postoperative Neurocognitive Disorder But Not Postoperative Delirium

10.21203/rs.3.rs-505070/v2 ◽

2021 ◽

Author(s):

Xingqu Chen ◽

Linji Li ◽

Li Yang ◽

Aijiao Li ◽

Miao Wu ◽

...

Keyword(s):

Clinical Trial ◽

Postoperative Delirium ◽

Controlled Trial ◽

Randomised Trial ◽

Postoperative Cognitive Dysfunction ◽

Control Group ◽

Neurocognitive Disorder ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Significant Difference

Abstract Background. Postoperative cognitive dysfunction (POCD) renamed of delayed neurocognitive recovery (up to 30 days) and postoperative neurocognitive disorder (up to 12 months), is a frequent complication of the neurological system associated with poor outcome. This randomised controlled trial was aimed to determine whether bispectral (BIS) monitoring has a correlation with delayed neurocognitive recovery, postoperative neurocognitive disorder, or postoperative delirium (POD). Methods.100 patients were assigned to the BIS group and 97 patients were assigned to the control group in the study. The BIS index was kept in 40-60 in the BIS group, and the depth of anesthesia in the control group was maintained according to anesthetists’ clinical experiences. The cognitive function was evaluated from the first day to the seventh day after the operation and the time of discharge, 1 month, 6th month and 1 year after the operation.Results. The incidence of delayed neurocognitive recovery (3% vs 21.6%, P＜0.001, at 7th day) (1% vs 21.1%, P＜0.001, at 1 month) and postoperative neurocognitive disorder (6.2% vs 21.3%, P=0.002, at 6th month) (4.4% vs 16.3% ,P=0.009, at 1 year) are lower in BIS group. While there is no significant difference between two group in POD (12% vs 19.6%, P=0.144). The average value of intraoperative BIS were lower in BIS group (43.75 vs 50.69,P＜0.001). The postoperative hospitalisation time （9.99 vs 12.41, P＜0.001) and the mortality (5.4% vs 14.4%, P=0.042) was significantly decreased while the satisfaction is higher in BIS group (39% vs 24.7%, P=0.009). Conclusions. Using BIS can decrease delayed neurocognitive recovery and postoperative neurocognitive disorder, while it is not associated with POD. BIS-monitoring can validly lessen the postoperative hospitalisation and mortality, and increase the satisfaction of patients.Clinical trial registration. Chinese Clinical Trial Registry, ChiCTR2000032463.http://www.chictr.org.cn/showproj.aspx?proj=33065

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Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

10.21203/rs.3.rs-20100/v1 ◽

2020 ◽

Author(s):

YANG BAI ◽

Ying Wang ◽

Bo Chen ◽

Qianqian Lei ◽

Hailong Zhao ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Frozen Shoulder ◽

Baseline Period ◽

Control Group ◽

Trial Registry ◽

Clinical Trial Registry ◽

Randomized Controlled ◽

Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

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The upper airway volume effects produced by Hyrax, Hybrid-Hyrax, and Keles keyless expanders: a single-centre randomized controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjaa031 ◽

2020 ◽

Author(s):

Gordon C Cheung ◽

Oyku Dalci ◽

Simone Mustac ◽

Spyridon N Papageorgiou ◽

Shanya Hammond ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Upper Airway ◽

Linear Regression Models ◽

Maxillary Expansion ◽

Volume Changes ◽

Clinical Trial Registry ◽

Small Magnitude ◽

Significant Difference ◽

Secondary Outcomes

Summary Objective To assess upper airway volume changes after rapid maxillary expansion (RME) with three different expanders. Trial design Three-arm parallel randomized clinical trial. Methods Sixty-six patients, 10–16 years old, in permanent dentition, with maxillary transverse deficiency were recruited and assigned with block randomization (1:1:1 ratio) and allocation concealment to three groups of 22 patients each (Hyrax, Hybrid-Hyrax, and Keles keyless expander). The primary outcome (overall upper airway volume change) and secondary outcomes (volume changes in the nasal cavity, nasopharynx, oropharynx, and hypopharynx) were blindly assessed on the initial (T0) and final (T1, 6 months at appliance removal) cone beam computed tomography. Differences across groups were assessed with crude or adjusted for confounders (gender, age, growth stage, skeletal pattern, baseline airway volume, and amount of expansion) linear regression models. Results Fifty-one patients were analysed (19, 19, and 13 in the Hyrax, Hybrid-Hyrax, and Keles groups). Maxillary expansion resulted in considerable increases in total airway volume in the Hybrid-Hyrax group (+5902.1 mm3) and less in the Hyrax group (+2537.9 mm3) or the Keles group (+3001.4 mm3). However, treatment-induced changes for the primary and all secondary outcomes were of small magnitude and no significant difference was seen among the three expanderes in the total airway volume in either crude or adjusted analyses (P > 0.05 in all instances). Finally, among pre-peak patients (CVM 1–3), the Hybrid-Hyrax expander was associated with significantly greater increases in total airway volume compared to the Hyrax expander (P = 0.02). Conclusions RME resulted in relatively small increases in total upper airway volume and its separate compartments, with mostly no statistically significant differences across the Hyrax, Hybrid-Hyrax, and Keles groups. Limitations Significantly greater attrition was found in the Keles group due to appliance failure. The current trial might possibly be under-powered to detect differences between groups, if such exist. Harms Keles expanders blocked during activations and required substitution for completion of treatment. Protocol The protocol was not published before trial commencement. Registration Australian and New Zealand Clinical Trial Registry (ACTRN12617001136392).

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The Influence of Differences in Solvents and Concentration on the Efficacy of Propofol at Induction of Anesthesia

Anesthesiology Research and Practice ◽

10.1155/2016/9178523 ◽

2016 ◽

Vol 2016 ◽

pp. 1-4

Author(s):

Yukako Obata ◽

Yushi U. Adachi ◽

Katsumi Suzuki ◽

Taiga Itagaki ◽

Hiromi Kato ◽

...

Keyword(s):

Venous Blood ◽

Surgical Patients ◽

Trial Registry ◽

Clinical Trial Registry ◽

Verbal Command ◽

Age And Gender ◽

Intravenous Anesthetic ◽

Significant Difference ◽

And Gender ◽

Significant Covariates

Background. Propofol is a popular intravenous anesthetic and varieties of formulations were produced from different laboratories. The present study compared efficacy of propofol of different laboratories and different concentrations (1 and 2%) during induction of anesthesia.Methods. Seventy-five scheduled surgical patients were randomly allocated into three groups. The patients of group D1 received AstraZeneca Diprivan 1% (Osaka, Japan) at a rate of 40 mg kg−1 h−1. Group M1 was given 1% Maruishi (Maruishi Pharmaceutical, Osaka, Japan) and group M2 was given 2% formulation at the same rate of propofol. Achieving hypnosis was defined as failure to open their eyes in response to a verbal command and the venous blood sample was withdrawn.Results. The hypnotic doses of M2 were significantly larger (D1:91.4±30.9, M1:90.7±26.7, and M2:118.4±40.2 mg, resp. (mean ± SD).p<0.005). Age and gender were selected as statistically significant covariates using general linear model-ANOVA. The blood concentration showed no significant difference among the groups (3.73±2.34,4.10±3.04, and4.70±2.12 μg mL−1, resp.).Conclusion. The required dose of propofol was different among the formulations; however, the serum concentration showed no significant difference. This trial is registered with UMIN Clinical Trial Registry:UMIN000019925.

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Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

10.21203/rs.3.rs-20100/v2 ◽

2020 ◽

Author(s):

YANG BAI ◽

Ying Wang ◽

Bo Chen ◽

Yinan QIN ◽

Qianqian Lei ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Frozen Shoulder ◽

Baseline Period ◽

Control Group ◽

Trial Registry ◽

Clinical Trial Registry ◽

Randomized Controlled ◽

Needle Acupuncture

Abstract Background: There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The aim of present study is to select an effective therapy for patients with idiopathic frozen shoulder.Methods: Randomized controlled trial will be conducted in the three clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patients will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of the treatment period, and a 12-weeks of the follow-up period. During the 3-weeks of the treatment period, patients will receive nine sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and measurement of range of joint motion (ROM) from the baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment.Discussion: The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals.Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

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A comparison of therapies using Eyetronix Flicker Glass and standard adhesive patches in children with anisometropic amblyopia: A randomized controlled trial

10.1101/2020.07.20.20157552 ◽

2020 ◽

Author(s):

Seung Hyun Min ◽

Shijia Chen ◽

Jinling Xu ◽

Bingzhen Chen ◽

Hui Chen ◽

...

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Contrast Sensitivity ◽

Primary Outcome ◽

Controlled Trial ◽

Trial Registry ◽

Clinical Trial Registry ◽

Treatment Groups ◽

Anisometropic Amblyopia ◽

Randomized Controlled

AbstractPurposeRecently, Eyetronix Flicker Glass (EFG) was introduced as a novel treatment for amblyopia. We conducted a randomized clinical trial to compare the efficacy of the therapies using the Eyetronix Flicker Glass and standard adhesive patches.MethodsWe tested 31 children (aged 4-13 years) with anisometropic amblyopia. They were assigned into one of the two treatment groups and were treated for 12 weeks. The first group was treated with the Eyetronix Flicker Glass for one hour per day (Flicker Group), and the latter with standard patches (Patching Group) for two hours per day. We considered best-corrected visual acuity (BVCA) of the amblyopic eye after 12 weeks of treatment as the primary outcome. Secondary outcomes were BVCA of the amblyopic at other timepoints of measurement (before the treatment, 3 and 6 weeks) as well as contrast sensitivity of the amblyopic eye, stereopsis and fusion range at all timepoints.ResultsVisual acuity in the amblyopic eye was significantly improved in both treatment groups at week 12 relative to baseline. The magnitude of improvement was similar. Contrast sensitivity of the amblyopic eye at 3, 6 and 12 cpd was large but not so at 18 cpd for both groups. Stereopsis did not improvement in both groups. However, fusion range significantly improved in the Flicker Group at week 12 relative to baseline.ConclusionAfter 12 weeks, EFG therapy improves amblyopic eye’s visual acuity, its contrast sensitivity and fusion range of the patients. EFG therapy improves both monocular and binocular functions.Clinical trial registry numberChiCTR2000034436 from the Chinese Clinical Trial Registry

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Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulder: study protocol for a randomized controlled trial

10.21203/rs.3.rs-20100/v3 ◽

2020 ◽

Author(s):

YANG BAI ◽

Ying Wang ◽

Bo Chen ◽

Yinan QIN ◽

Qianqian Lei ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Frozen Shoulder ◽

Baseline Period ◽

Control Group ◽

Trial Registry ◽

Clinical Trial Registry ◽

Randomized Controlled ◽

Needle Acupuncture

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Primary success of electrical cardioversion for new-onset atrial fibrillation and its association with clinical course in non-cardiac critically ill patients: sub-analysis of a multicenter observational study

Journal of Intensive Care ◽

10.1186/s40560-021-00562-8 ◽

2021 ◽

Vol 9 (1) ◽

Author(s):

Nozomu Shima ◽

Kyohei Miyamoto ◽

Seiya Kato ◽

Takuo Yoshida ◽

Shigehiko Uchino ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Sinus Rhythm ◽

Trial Registry ◽

Clinical Trial Registry ◽

Icu Discharge ◽

Primary Success ◽

Success Group ◽

Onset Atrial Fibrillation ◽

New Onset

Abstract Background Electrical cardioversion (ECV) is widely used to restore sinus rhythm in critically ill adult patients with atrial fibrillation, although its prognostic value is uncertain. This study aims to elucidate the clinical meaning of successful ECV. Methods This is a sub-analysis of the AFTER-ICU study, a multicenter prospective study with a cohort of 423 adult non-cardiac patients with new-onset atrial fibrillation (AF). Patients that underwent ECV within 7 days after initial onset of AF were included in the sub-analysis. We compared intensive care unit (ICU) and overall hospital mortality, survival time within 30 days, cardiac rhythm at ICU discharge, and the length of ICU and overall hospital stay between patients whose sinus rhythm was restored immediately after the first ECV session (primary success group) and those in whom it was not restored (unsuccessful group). To find the factors related to the primary success of ECV, we also compared patient characteristics, the delivered energy, and pretreatment. Results Sixty-five patients received ECV and were included in this study. Although 35 patients (54%) had primary success, recurrence of AF occurred in 24 of these patients (69%). At ICU discharge, three patients still had AF in the unsuccessful group, but no patients in the primary success group still had AF. ICU mortality was 34% in the primary success group and 17% in the unsuccessful group (P = 0.10). Survival time within 30 days did not differ between the groups. Delivered energy and pretreatment were not associated with primary success of ECV. Conclusions The primary success rate of ECV for new-onset AF in adult non-cardiac ICU population was low, and even if it succeeded, the subsequent recurrence rate was high. Primary success of ECV did not affect the rate of mortality. Pretreatment and delivered energy were not associated with the primary success of ECV. Trial registration UMIN clinical trial registry, the Japanese clinical trial registry (registration number: UMIN000026401, March 31, 2017).

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Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

Clinical Oral Investigations ◽

10.1007/s00784-021-04093-2 ◽

2021 ◽

Author(s):

Mayte Buchbender ◽

Jakob Fehlhofer ◽

Peter Proff ◽

Tobias Möst ◽

Jutta Ries ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Oral Cavity ◽

Bowel Disease ◽

Trial Registry ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Expression Levels ◽

Inflammatory Bowel ◽

Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

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