Randomized Double-blind Clinical Trial of Bleaching Products in Patients Wearing Orthodontic Devices

SUMMARY Objectives: This double-blind randomized clinical trial evaluated tooth sensitivity (TS) and the effectiveness (EF) of two types of bleaching agents (Trèswhite Ortho [TWO] and Trèswhite Supreme [TWS]) when used in patients wearing orthodontic appliances. Methods and Materials: Forty patients between the ages of 18 and 40 years were randomly stratified, with an equal allocation rate, into two groups (n=20), according to the bleaching agent applied. Tooth color of the six maxillary anterior teeth was measured before and after the treatment with a spectrophotometer. The TS was recorded on three scales before and during the bleaching treatment. Results: With regard to EF, a significant reduction was found (ranging from 7.3-9.6 and 5.3-9.5 Vita scale units for TWO and TWS, respectively, p<0.001); however, there was no statistical difference between the groups (p>0.63). The number of patients with sensitivity was 58.8% and 73.3% for TWO and TWS groups, respectively (p=0.53); however, with each of the three scales used, the intensity of sensitivity was low and there was no statistical difference between TWO and TWS (p>0.05). Conclusions: In spite of producing a side effect of low TS, the two bleaching treatments tested were effective for dental bleaching in patients with fixed orthodontic appliances.

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SYMPHYTUM OFFICINALE IN THE TREATMENT OF PLANTAR KERATOSIS IN DIABETIC PATIENTS: DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

10.36106/ijsr/3730706 ◽

2021 ◽

pp. 62-64

Author(s):

Beatriz Bertolaccini Martínez ◽

Elisa Coutinho Moura

Keyword(s):

Clinical Trial ◽

Salicylic Acid ◽

Statistical Analysis ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Before And After ◽

Type 2 Diabetic

PURPOSE: To compare the efcacy between SO and salicylic acid SA in the treatment of plantar keratosis of diabetic patients. METHODS: Randomized, double-blind clinical trial, with 47 type 2 diabetic patients, both sexes and with plantar keratosis. Patients were randomized into 2 groups: G1 (n = 48; treated with 15% SO extract) and G2 (n = 46; treated with 10% AS). The feet were photographed before (D0) and after the treatment (D30) and keratosis areas were measured using the Image J software. For each patient, a lesion in each foot was analyzed. The results were expressed by median. In the statistical analysis, the Wilcoxin test was used to compare the lesion areas before and after treatments and the Mann-Whitney test was used to compare the regression of the lesion areas between the two groups. P <0.05 was adopted. RESULTS: G1 (D0 = 2 8.156 vs D30 = 2.226; p <0.0001) and G2 (D0 = 4.835 vs D30 = 2.059; p <0.0001) showed a difference between the areas (cm ) of the keratosis, 2 before and after the treatment. There was a difference in the regression of the areas (cm ) of keratosis, between G1 and G2, respectively (4.540 vs 1.171, p <0.0001). CONCLUSION: Symphytum ofcinale proved to be more effective than Salicylic Acid in the treatment of plantar keratosis in diabetic patients.

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Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v30i430276 ◽

2019 ◽

pp. 1-8

Author(s):

Mohammad Ali Mapar ◽

Ali Asghar Hemmati ◽

Ghazal Namdari

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Double Blind ◽

Laboratory Findings ◽

Double Blind Clinical Trial ◽

Metformin Group ◽

Significant Difference ◽

Before And After ◽

P 16 ◽

The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

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Evaluation of the Additive Effect of Domperidone on Patients with Refractory Gastroesophageal Reflux Disease; A Randomized Double Blind Clinical Trial

Middle East Journal of Digestive Diseases ◽

10.15171/mejdd.2018.124 ◽

2018 ◽

Vol 11 (1) ◽

pp. 24-31 ◽

Cited By ~ 1

Author(s):

Tarang Taghvaei ◽

Arash Kazemi ◽

Vahid Hosseini ◽

Mehdi Hamidian ◽

Hafez Tirgar Fakheri ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Gastroesophageal Reflux Disease ◽

Gastroesophageal Reflux ◽

Erosive Esophagitis ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Significant Difference ◽

Before And After

BACKGROUND Gastroesophageal reflux disease (GERD) is a common problem with annoying symptoms. It is associated with negative impact on quality of life. Prokinetic agents may be used in combination with acid suppression agents as an adjunctive in patients with GERD refractory to proton pump inhibitors (PPI) therapy, rather than as sole treatment. This study aimed to evaluate the efficacy of combination of PPI with domperidone (a prokinetic agent) compared with PPI alone in the treatment of patients with refractory GERD. METHODS This study was a double blind clinical trial on 29 patients with GERD refractory to PPI during the period of one month. By randomization, the patients were divided into two groups. Group A was treated by pantoprazole 40 mg twice daily and domperidone three times a day for a month, while group B was treated by pantoprazole 40 mg twice daily and placebo three times a day. In this study endoscopy was performed to evaluate the prevalence of erosive esophagitis, non-erosive reflux, and hiatal hernia. Manometry was conducted to study the prevalence of dysmotility. GERD symptom questionnaires including the Gastrointestinal Symptom Rating Scale (GSRS), Carlson Dennett, and the Medical Outcomes Study Short Form-36 health survey (SF36) were used before and after treatment for screening GERD and assessing treatment response. RESULTS There were 17 (58.62%) women and 12 (41.37%) men. The prevalence of erosive esophagitis and non-erosive reflux, was 10.34% and 89.66%, respectively. There was a significant difference comparing reflux symptoms before and after treatment between the two groups according to reflux and Carlson Dennett questionnaires. At the end of the study, symptoms of reflux significantly improved by treatment. Although, the quality of life questionnaire scores improved by treatment, there was no statistically significant difference in response to treatment between the two groups. CONCLUSION In this research, we showed that adding domperidone to PPI could not make any improvement in patients with refractory reflux regarding the quality of life and improving the symptoms.

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Evaluation of In-office Vital Tooth Whitening Combined with Different Concentrations of At-home Peroxides: A Randomized Double-blind Clinical Trial

The Open Dentistry Journal ◽

10.2174/1874210601913010377 ◽

2019 ◽

Vol 13 (1) ◽

pp. 377-382

Author(s):

Leandro Féliz-Matos ◽

Ninoska Abreu-Placeres ◽

Luis Miguel Hernandez ◽

Carlos Ruiz-Matuk ◽

Patricia Grau-Grullón

Keyword(s):

Clinical Trial ◽

Hydrogen Peroxide ◽

Color Change ◽

Carbamide Peroxide ◽

Tooth Whitening ◽

Double Blind ◽

Tooth Color ◽

Positive Effects ◽

Double Blind Clinical Trial ◽

At Home

Background: The clinical evidence relate the effect of associating the in-office and at home vital tooth whitening, describing positive effects on tooth color change and reduction of dental sensitivity. Objective: The purpose of this randomized double-blind clinical trial was to evaluate the effect on the shortened application of in-office vital tooth whitening combined with different concentrations of at-home peroxides in the final tooth color change and dental sensitivity. Methods: Randomized double-blind clinical trial with 120 participants between 18-65 years, allocated in four tooth whitening treatment groups: G1= Carbamide Peroxide 10% + Hydrogen Peroxide 40%, G2= Carbamide Peroxide 15% + Hydrogen Peroxide 40%, G3= Carbamide Peroxide 20% + Hydrogen Peroxide 40%, G4= Hydrogen Peroxide 10% + Hydrogen Peroxide 40% was conducted. Tooth color was measured at baseline and dental sensitivity and tooth color change during and after treatment. Results: No statistical significant differences were found in tooth color change (superior arch p= 0.183 / inferior arch p= 0.374), and in dental sensitivity (p=0.268). Conclusion: Reducing the application time of in-office whitening, combined with in-home products was effective in improving the color. All groups resulted in identical final color change and dental sensitivity. Clinicaltrials.gov: NCT02682329 Available from: https://clinicaltrials.gov/ct2/show/NCT02682329?term=hydrogen+peroxide.

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Clinical efficacy of an Aloe Vera gel versus a 0.12% chlorhexidine gel in preventing traumatic ulcers in patients with fixed orthodontic appliances: a double-blind randomized clinical trial

Odontology ◽

10.1007/s10266-019-00468-w ◽

2019 ◽

Vol 108 (3) ◽

pp. 470-478 ◽

Cited By ~ 1

Author(s):

Cristina Leiva-Cala ◽

Alejandro Ismael Lorenzo-Pouso ◽

Belén Centenera-Centenera ◽

Juan López-Palafox ◽

Pilar Gándara-Vila ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Clinical Efficacy ◽

Aloe Vera ◽

Orthodontic Appliances ◽

Double Blind ◽

Aloe Vera Gel ◽

Fixed Orthodontic Appliances ◽

Chlorhexidine Gel

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Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial

British Homeopathic Journal ◽

10.1054/homp.1999.0328 ◽

2000 ◽

Vol 89 (01) ◽

pp. 8-12 ◽

Cited By ~ 59

Author(s):

A Balzarini ◽

E Felisi ◽

A Martini ◽

F De Conno

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Controlled Clinical Trial ◽

Double Blind ◽

Skin Reactions ◽

Double Blind Placebo ◽

X Ray ◽

Homeopathic Treatment ◽

Double Blind Clinical Trial ◽

Number Of Patients

AbstractThe aim of this study was to assess the effects of Belladonna 7cH and X-ray 15cH associated in the treatment of acute radiodermatitis. A randomized double-blind placebo-controlled clinical trial involving 66 patients who had been operated on for breast cancer and were undergoing radiotherapy was conducted. The following parameters were assessed over ten weeks: breast skin colour, warmth, swelling and pigmentation.The efficacy of the treatment was assessed by the comparison of these parameters taken individually and by calculating an Index of Total Severity (sum of the scores of the four parameters) during radiotherapy, and during recovery, 15 and 30 d after the end of the radiotherapy.The differences of the scores of the Index of Total Severity during Radiotherapy were not statistically significant, but showed a trend towards a better activity of the homoeopathic medicine compared to placebo. Analysis of the data on Total Severity during recovery, showed a statistically significant benefit of the active medicines over placebo. The homeopathic medicines had particular effectiveness on the heat of the skin.The limited number of patients observed and the posology employed could have interfered with the significance of the results. Chemotherapy and hormonotherapy do not seem to affect the results.

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A visual evaluation of oral plaque removal utilizing an adjunct enzyme pre-rinse in orthodontic subjects

The Angle Orthodontist ◽

10.2319/120819-776.1 ◽

2020 ◽

Vol 90 (6) ◽

pp. 844-850

Author(s):

Jennifer Rose ◽

Ahmed Ghoneima ◽

Frank Lippert ◽

Lisa Maxwell ◽

George Eckert ◽

...

Keyword(s):

Clinical Trial ◽

Repeated Measures ◽

Orthodontic Appliances ◽

Visual Evaluation ◽

Double Blind ◽

Plaque Score ◽

Significance Level ◽

Plaque Removal ◽

Repeated Measures Analysis ◽

Fixed Orthodontic Appliances

ABSTRACT Objective To determine if an adjunct proteolytic pre-rinse along with contemporary methods of dental cleaning may more effectively remove visual plaque in subjects with fixed orthodontic appliances. Materials and Methods Forty-three orthodontic subjects, ages 10 to 25, completed this single site, double-blind, crossover clinical trial. Subjects randomly received bromelain enzyme or a powdered-sugar placebo pre-rinse, followed by manual tooth brushing and use of a Waterpik. Subjects received the alternate pre-rinse during the subsequent visit. Baseline and residual plaque accumulation were recorded via disclosing tablet and digital photography. A single, blinded examiner scored visual plaque scores from randomized photographs. Treatment effects on composite plaque score were evaluated using repeated-measures analysis of variance. A 5% significance level was used for all tests. Results No significant differences in plaque scores were noted at baseline or post-rinse between the enzyme and placebo. The changes from baseline to post-rinse (P = .190), post-brushing (P = .764), and post-Waterpik (P = .882) were not significantly different between interventions. Significant reduction in plaque scores were observed in both arms of the study after brushing (P < .01) and waterjet use (P < .01). Neither age (P = .220) nor gender (P = .449) impacted plaque scores. Conclusions Use of a bromelain enzyme pre-rinse alone did not significantly enhance plaque removal. A significant reduction in retained plaque was observed with the application of brushing and or Waterpik.

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Comparison of Whitening Dentifrices on the Effectiveness of In-office Tooth Bleaching: A Double-blind Randomized Controlled Clinical Trial

Operative Dentistry ◽

10.2341/17-333-c ◽

2019 ◽

Vol 44 (2) ◽

pp. 138-145 ◽

Cited By ~ 3

Author(s):

N Jiang ◽

C Zhang ◽

C Agingu ◽

T Attin ◽

H Cheng ◽

...

Keyword(s):

Clinical Trial ◽

Tooth Bleaching ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Double Blind ◽

Tooth Color ◽

Color Changes ◽

Randomized Controlled ◽

Anterior Teeth ◽

Repeated Analysis

SUMMARY Objectives: To investigate the effect of whitening dentifrices on the effectiveness of in-office tooth bleaching. Methods and Materials: A double-blind randomized controlled clinical trial was performed. The participants were randomly allocated into three groups according to the different dentifrices used during this clinical trial: regular dentifrice (group C), conventional whitening dentifrice (group CW), and whitening dentifrice containing blue covarine (group CU). All participants received in-office tooth bleaching for the maxillary anterior teeth (two sessions conducted at a one-week interval). Tooth color was measured with a spectrophotometer at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3); one week after the completion of in-office bleaching (T4); and three weeks after the completion of in-office bleaching (T5). The data were statistically analyzed through repeated analysis of variance and the Tukey test (α=0.05). Results: Sixty participants completed the study (n=20 per group). At T3, group CU exhibited the lowest ΔE values (p=0.008). The ΔE values increased from T4 to T5 in the CW and CU groups, whereas a decrease in ΔE values was observed for group C. Conclusions: The use of a whitening dentifrice containing blue covarine during in-office bleaching reduced color changes. After tooth bleaching, brighter tooth colors were observed in the participants who brushed with whitening dentifrices compared to those who brushed with a regular dentifrice.

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Effects of a Betaine-containing Toothpaste on Subjective Symptoms of Dry Mouth: A Randomized Clinical Trial

The Journal of Contemporary Dental Practice ◽

10.5005/jcdp-4-2-11 ◽

2003 ◽

Vol 4 (2) ◽

pp. 11-23 ◽

Cited By ~ 13

Author(s):

Irma Rantanen ◽

Jorma Tenovuo ◽

Kaisu Pienihäkkinen ◽

Eva Söderling

Keyword(s):

Clinical Trial ◽

Visual Assessment ◽

Randomised Clinical Trial ◽

Dry Mouth ◽

Subjective Symptoms ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Before And After ◽

Vas Scores ◽

Dental Appointments

Abstract Our aim was to study the effects of mildly flavoured sodium lauryl sulphate (SLS)-containing and detergent-free toothpastes with and without betaine (BET) on subjective symptoms of dry mouth in a randomised clinical trial. BET is an osmoprotectant that reacts with molecules to supply the surface with a water coating that protects cells from surfactants. Twenty-seven xerostomic patients and 18 healthy controls took part in the randomised, double-blind clinical trial with a crossover design. Three mildly flavoured toothpastes: (1) 4% BET, (2) 1% SLS and 4% BET, and (3) 1% SLS were used for six weeks each. The reference or washout paste contained neither SLS nor BET. The subjects’ dental appointments were at the beginning of the trial and before and after the use of each toothpaste. At each appointment, the subjects were interviewed about subjective sensations of dry mouth (Visual Assessment Scoring (VAS) Index). The subjects did not report any adverse effects in connection with the use of the toothpastes. The VAS scores for lip dryness and eating difficulties were significantly lower for the BET paste (lip dryness: BET<BET+SLS; p < 0.005 and eating difficulties: BET<BET+SLS; p = 0.02; BET<reference; p = 0.003). The BET paste relieved dry mouth symptoms in 44% of the xerostomic patients, the corresponding figures for the other pastes being BET+SLS 22% (p = 0.002 as compared with BET), SLS 18% (p = 0.022), and reference 7% (p = 0.000). In conclusion, all the mildly flavoured toothpastes used in this study were well accepted by the xerostomic subjects. Thus, other toothpaste components may be more mucosa-irritating than just SLS, or else they enhance the effect of SLS. The detergent-free, BET-containing toothpaste appeared to be associated with relief of some symptoms of dry mouth. Citation Rantanen I, Tenovuo J, Pienihäkkinen K, et. al. Effects of a betaine-containing toothpaste on subjective symptoms of dry mouth, a randomised clinical trial. J Contemp Dent Pract 2003 May;(4)2:011-023.

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