scholarly journals Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Muhanad AlHareky ◽  
Jehan AlHumaid ◽  
Sumit Bedi ◽  
Maha El Tantawi ◽  
Mazin AlGahtani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
The United States ◽  
Nerve Fibers ◽  
T Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Dental Anesthesia ◽  
Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals The Effect of Medium Chain Triglycerides on Time to Nutritional Ketosis and Symptoms of Keto-Induction in Healthy Adults: A Randomised Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Cliff J. d C. Harvey ◽  
Grant M. Schofield ◽  
Micalla Williden ◽  
Joseph A. McQuillan
Keyword(s):  
Clinical Trial ◽  
Healthy Adults ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Medium Chain Triglycerides ◽  
Clinical Trial Registry ◽  
Medium Chain ◽  
Low Carbohydrate ◽  
Randomised Controlled ◽  
Beta Hydroxybutyrate

Medium chain triglycerides (MCTs) are ketogenic and might reduce adverse effects of keto-induction and improve time to ketosis and the tolerability of very low carbohydrate diets. This study investigates whether MCT supplementation improves time to nutritional ketosis (NK), mood, and symptoms of keto-induction. We compared changes in beta-hydroxybutyrate (BOHB), blood glucose, symptoms of keto-induction, and mood disturbance, in 28 healthy adults prescribed a ketogenic diet, randomised to receive either 30 ml of MCT, or sunflower oil as a control, three times per day, for 20 days. The primary outcome measured was the achievement of NK (≥0.5 mmol·L−1 BOHB). Participants also completed a daily Profile of Mood States and keto-induction symptom questionnaire. MCT resulted in higher BOHB at all time points and faster time to NK, a result that failed to reach significance. Symptoms of keto-induction resulted from both diets, with a greater magnitude in the control group, except for abdominal pain, which occurred with greater frequency and severity in the MCT-supplemented diet. There was a possibly beneficial effect on symptoms by MCT, but the effect on mood was unclear. Based on these results, MCTs increase BOHB compared with LCT and reduce symptoms of keto-induction. It is unclear whether MCTs significantly improve mood or time to NK. The trial was registered by the Australia New Zealand Clinical Trial Registry ACTRN12616001099415.

scholarly journals HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcers ◽  
Calotropis Procera ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Clinical Trial Registry ◽  
Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

scholarly journals Telephone intervention to promote maternal breastfeeding self-efficacy: randomized clinical trial

2021 ◽  
Vol 55 ◽  
Author(s):  
Hilana Dayana Dodou ◽  
Raylla Araújo Bezerra ◽  
Anne Fayma Lopes Chaves ◽  
Camila Teixeira Moreira Vasconcelos ◽  
Lorena Pinheiro Barbosa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Short Form ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Telephone Intervention ◽  
Clinical Trial Registry

ABSTRACT Objective: To analyze the effects of an educational intervention via telephone on maternal breastfeeding self-efficacy. Method: Randomized controlled clinical trial including 240 puerperae from a secondary care hospital randomized into two groups: control and intervention. The educational intervention took place at seven, 30, 90, and 150 days postpartum and centered on self-efficacy and motivational interviewing principles. Self-efficacy was measured by the Breastfeeding Self-Efficacy Scale – Short Form. The data followed the abnormal distribution, so non-parametric tests were used. Results: The intervention group obtained higher median breastfeeding self-efficacy scores across the three outcome measures when compared to the control group (p < 0,001). Furthermore, the intervention group showed increased self-efficacy scores at all monitoring moments, which shows that the educational intervention was able to raise and maintain women’s confidence in breastfeeding their child over time. Conclusion: The use of a telephone-based intervention focused on self-efficacy principles and delivered by trained nurses effectively promoted maternal confidence in breastfeeding. Brazilian Clinical Trial Registry: RBR-7m7vc8.

Evaluation of Subantimicrobial Dose Doxycycline as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients with Diabetes: A Randomized, Placebo-Controlled Clinical Trial

2010 ◽  
Vol 11 (3) ◽  
pp. 9-16 ◽  
Author(s):  
Satish Gupta ◽  
Manohar L. Bhongade ◽  
Vikas Deo ◽  
Ritika Jaiswal
Keyword(s):  
Clinical Trial ◽  
Chronic Periodontitis ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Patients ◽  
Scaling And Root Planing ◽  
Pocket Depth ◽  
Root Planing ◽  
Patients With Diabetes

Abstract Aim Diabetic patients have more severe periodontal destruction, but periodontal therapy can improve metabolic control. Recently, interest has focused on the use of subantimicrobial dose doxycycline (SDD) as a treatment paradigm. Therefore, this study was undertaken to evaluate clinical efficacy of SDD with scaling and root planning (SRP) in chronic periodontitis patients with diabetes. Methods and Materials Twenty chronic periodontitis patients with diabetes mellitus were randomly allocated to either a test and a control group. Clinical measurements were recorded at baseline and at six months for probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR). After SRP, patients in the test group were instructed to take SDD 20-mg capsules twice a day while patients in the control group took a placebo twice a day. Both groups were on this regimen for a six-month period. Results A greater reduction in mean PPD was demonstrated in patients in the test group compared to the control group. The mean CAL increase observed in the test group was significantly greater (0.67 mm) than that in the control group. Conclusion It can be concluded that SRP, in conjunction with the SDD therapy described, is more effective then SRP alone in terms of CAL gain and PPD reduction in diabetic patients with severe periodontal disease. Clinical Significance Given the widespread prevalence of both chronic periodontitis and diabetes, the proposed treatment approach will prove to be of great value and contribute significantly to the overall health of the patients. Citation Deo V, Gupta S, Bhongade ML, Jaiswal R. Evaluation of Subantimicrobial Dose Doxycycline as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients with Diabetes: A Randomized, Placebo-Controlled Clinical Trial. J Contemp Dent Pract [Internet]. 2010 May; 11(3):009-016. Available from: http://www.thejcdp.com/journal/view/volume11- issue3-deo.

scholarly journals The effect of group therapy using the cognitive approach on the empowerment of mothers raising a child with autistic disorder:A randomized-controlled clinical trial

2019 ◽  
Vol 7 (1) ◽  
pp. 23-31
Author(s):  
Hossein Ebrahimi ◽  
Maryam Vahidi ◽  
Ayyoub Malek ◽  
Jalil Babapour Kheiroddin ◽  
Nafiseh Abdorrahmani
Keyword(s):  
Clinical Trial ◽  
Group Therapy ◽  
Autistic Disorder ◽  
Intervention Group ◽  
Routine Care ◽  
T Test ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Cognitive Approach

Introduction: The diagnosis of autistic disorder may impose stress on the child’s parents especially the mother of the baby. Raising a child with autistic disorder reduces parents' quality of life. This study examined the effect of group therapy using a cognitive approach on empowerment in the mothers of children with autistic disorder. Methods: This randomized clinical trial was carried out with 80 mothers of children with the autistic disorder. They referred to Autism Society Rehabilitation Center in Tabriz, Iran. The mothers were randomly allocated into intervention and control groups. The intervention group was divided into 4 groups of 10, and each group participated in 10 sessions of group therapy using the cognitive approach. The control group received the routine care. Data were collected using the Family Empowerment Scale (FES) before the intervention and two months after the intervention. Data were analysed using descriptive and inferential statistics [t-test, χ2, and analysis of covariance (ANCOVA)] via the SPSS software. Results: The independent t-test showed that the means of total empowerment and its dimensions had no statistically significant differences before the intervention. However, after the intervention, such differences between the groups were statistically significant (P < 0.001); so that the mothers in the intervention group achieved higher scores on empowerment and its dimensions compared with the control group. Conclusion: Group therapy using the cognitive approach can be used by healthcare professionals in rehabilitation centers for empowering the mothers of children with autistic disorder.

scholarly journals Dentin hypersensitivity treatment with ozonated oil: a randomized controlled triple-blind clinical trial

2021 ◽  
Vol 10 (17) ◽  
pp. e147101724234
Author(s):  
Allan Warley Silva Souza ◽  
Gabriel Andrade Telles Silveira ◽  
Higor de Souza Ferreira Oliveira ◽  
José Cristiano Ramos Glória ◽  
Patricia Furtado Gonçalves ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Oral Health ◽  
Olive Oil ◽  
Rating Scale ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Dentin Hypersensitivity

The present study aimed to assess dentin hypersensitivity (DH) level and quality of life in patients before and after treatment with ozonated oil compared with extra virgin oil. This is a randomized triple-blind controlled clinical trial, consisting of patients with dentin hypersensitivity which was stimulated by evaporative and thermal stimuli. DH level was measured using a numerical rating scale. The patients were treated with ozonated oil and olive oil. Data were measured at baseline, immediately, and 4 weeks after treatment. The Dentine Hypersensitivity Experience Questionnaire (DHEQ-15) and the Oral Health Impact Profile (OHIP-14) were applied at baseline and 4 weeks after treatment. The sample consisted of 8 women and 3 men, with an average age of 23.82 years. The test group was 40 teeth while the control group consisted of 36 teeth, with the most prevalent tooth being the incisor (52.6%). There was a significant reduction in the DH level and an improvement in the quality of life after treatment. Among the sample, 90.1% reported an improvement in the final result. Both ozonated oil and olive oil were effective in reducing dentin hypersensitivity level and improving oral health-related quality of life 30 days after treatment.

scholarly journals Baidu Jieduan Granule in the Treatment of Coronavirus Disease-2019 (COVID-19): Study Protocol for an Open-Label Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Wen Zhang ◽  
Qin Xie ◽  
Xiaoming Xu ◽  
Shuting Sun ◽  
Tian Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Theory And Practice ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Randomized Controlled ◽  
Epidemic Diseases

Abstract Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan Granule in curing COVID-19. Methods/design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan Granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events will be monitored throughout the trial.Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan Granule in treatment of severe COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration: Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

scholarly journals Healing of intrabony defects following regenerative surgery by means of single-flap approach in conjunction with either hyaluronic acid or an enamel matrix derivative: a 24-month randomized controlled clinical trial

2021 ◽  
Author(s):  
Andrea Pilloni ◽  
Mariana A. Rojas ◽  
Lorenzo Marini ◽  
Paola Russo ◽  
Yoshinori Shirakata ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Enamel Matrix Derivative ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Enamel Matrix ◽  
Randomized Controlled Clinical Trial ◽  
Intrabony Defects ◽  
Randomized Controlled ◽  
Matrix Derivative

Abstract Objectives The aim of this randomized controlled clinical trial was to compare the clinical outcomes obtained in intrabony defects following regenerative periodontal surgery using the single-flap approach (SFA) in conjunction with either hyaluronic acid (HA) or enamel matrix derivative (EMD). Materials and methods Thirty-two intrabony defects in 32 healthy subjects were randomly assigned: HA (test group) or EMD (control group). Clinical attachment level (CAL), probing depth (PD), gingival recession (REC), and bleeding on probing (BOP) were recorded at baseline,12, 18, and 24 months after surgery. Results At 24 months, both treatments resulted in statistically significant clinical improvements evidenced by PD-reduction and CAL-gain (p<0.001). The mean CAL-gain was 2.19±1.11 mm in the test and 2.94±1.12 mm in the control sites (p=0.067). PD-reduction was statistically significantly higher for the control group (4.5±0.97 mm) than the test group (3.31±0.70 mm), (p=0.001). CAL-gain ≤ 3 mm was observed in 87.5% and in 62.5% of the test and control sites, respectively. Test sites showed slightly lower REC values than the control sites. No statistically significant differences were found for BOP between treatments. Conclusions The present findings indicate that both treatments led to statistically significant clinical improvements compared to baseline, although the application of EMD resulted in statistically significantly higher PD-reduction compared to the use of HA. Clinical relevance The use of HA in conjunction with a SFA resulted in significant PD-reduction and CAL-gain, pointing to the potential clinical relevance of this material in regenerative periodontal surgery.

scholarly journals A Two-year Randomized Clinical Trial of Chlorhexidine Varnish on Dental Caries in Chinese Preschool Children

2006 ◽  
Vol 85 (6) ◽  
pp. 557-559 ◽  
Author(s):  
M.Q. Du ◽  
B.J. Tai ◽  
H. Jiang ◽  
E.C.M. Lo ◽  
M.W. Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preschool Children ◽  
Dental Caries ◽  
Test Group ◽  
World Health ◽  
Primary Molars ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Health Organization ◽  
Double Blinded

The objective of this study was to assess the effect of six-monthly professional applications of chlorhexidine varnish on the prevention of dental caries in primary molars in Chinese preschool children. In a double-blinded, randomized, placebo-controlled clinical trial, 334 children aged 4–5 years were randomly divided into two groups. Children in the test group received six-monthly applications of a 40% chlorhexidine varnish, and the control children received a placebo varnish. Caries status of the children was assessed by two calibrated examiners at baseline and after 24 months, according to criteria recommended by the World Health Organization. The two-year mean caries increments in the test and the control group children were 1.0 and 1.6 decayed, missing, or filled molar surfaces (dmfs-molar), respectively, a 37.3% reduction ( t test, p = 0.036). No side-effects were found. It was concluded that six-monthly applications of chlorhexidine varnish were effective in reducing the incidence of dental caries in primary molars.

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