scholarly journals Study protocol for a randomized clinical trial to evaluate the effect of the use of Xylitol gum in the prevention of caries lesions in children living in Ladakh—the Caries Prevention Xylitol in Children (CaPreXCh) trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Maria Grazia Cagetti ◽  
Fabio Cocco ◽  
Ezio Calzavara ◽  
Davide Augello ◽  
Phunchok Zangpoo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Examination ◽  
Caries Prevention ◽  
Chewing Gum ◽  
Link Type ◽  
School Based ◽  
Plaque Ph ◽  
Caries Increment ◽  
Chewing Gums ◽  
Permanent Molars

Abstract Background Xylitol use is reported to be able to reduce dental plaque amount and cariogenic bacteria and, as a consequence, the caries increment. Only few data on the oral health of Ladakh’s population are available. The aim of the present protocol will be to record the caries prevalence of primary and permanent molars of schoolchildren living in Ladakh and to implement a school-based Xylitol programme, named the Caries Prevention Xylitol in Children (CaPreXCh) trial, using chewing gums. Methods The protocol is designed as a triple-blind randomized, controlled, parallel-group clinical trial in children aged 5–14 years. The study should have been carried out from August 2021 to August 2024 in Zanskar Valley (Ladakh), but the COVID-19 pandemic does not allow today to make predictions on the exact start. Participants will be randomly allocated into two groups: subjects who will receive a chewing gum with Xylitol (70% w/v) as only sweetener, and those who will receive a sugared chewing gum containing Maltitol (23% w/v). The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon) for one school year. Clinical examination will comprise an oral examination in which caries index (ICDAS scores), bleeding on probing and plaque pH evaluation after sucrose challenge will be recorded at baseline (t0); the clinical examination will be repeated after 12 months since the beginning of the chewing gum administration period (t1), after another 12-month period (t2) and finally after further 12 months (t3) (24 months from the end of the chewing gum use). The primary outcome will be the caries increment measured both at enamel and dentinal levels on primary and permanent molars. Data analysis will be conducted through Kaplan-Meyer graphs to evaluate caries increment. A comparison of the methods will be carried out with Cox regression with shared frailty. The net caries increment for initial, moderate and severe caries levels, using ICDAS (Δ-initial, Δ-moderate and Δ-severe), will be calculated. Discussion This trial will be the first trial conducted in India assessing the efficacy of a school-based caries preventive programme through the use of chewing gum containing only Xylitol as a sweetener. The findings could help strengthen the evidence for the efficacy of Xylitol use in community-based caries prevention programmes in children. Trial registration Clinical trials.govNCT04420780. Registered on June 9, 2020

scholarly journals Clinical Evaluation of the Retention of Resin and Glass Ionomer Sealants Applied as a Part of School-Based Caries Prevention Program

2019 ◽  
Vol 7 (23) ◽  
pp. 4127-4130
Author(s):  
Asem Alkhodairi ◽  
Moahmmad Alseweed ◽  
Sulaiman Alwashmi ◽  
Ramy Elmoazen
Keyword(s):  
Clinical Evaluation ◽  
Prevention Program ◽  
Contralateral Side ◽  
Caries Prevention ◽  
Glass Ionomer ◽  
School Based ◽  
Permanent Molars ◽  
Resin Sealant ◽  
Pits And Fissures ◽  
First Permanent Molars

BACKGROUND: Using of sealant on pits and fissures is likely one of the most generally well-known strategies by the new cavity-prevention systems. AIM: The purpose of this research is to measure the retentiveness of sealants of resin-modified ionomer glass cement (GIC) and resin pits and fissures, on the first permanent molars of special patients as a part of caries prevention program in schools. METHODS: The sample was comprised by 60 molars. Resin-based sealants on one side and glass-ionomer sealant on the contralateral side of the mouth. The molars were examined in three and six months after application for retention with three standards: TR: Totally Retained; PR: Partially Retained; and CL: Completely Lost. RESULTS: by the end of the study 60% of resin sealant was present. While 55% of GIC were retentive after 6 months. CONCLUSION: Resin sealants are more retentive than glass ionomer sealants in school-based carries prevention program.

scholarly journals Effect of dietary combinations on plaque pH recovery after the intake of pediatric liquid analgesics

2015 ◽  
Vol 09 (03) ◽  
pp. 340-345 ◽  
Author(s):  
Shaam Saeed ◽  
Nada Bshara ◽  
Juliana Trak ◽  
Ghiath Mahmoud
Keyword(s):  
Clinical Trial ◽  
Statistical Analysis ◽  
Randomized Clinical Trial ◽  
Sampling Method ◽  
Chewing Gum ◽  
P Value ◽  
Plaque Ph ◽  
Significant Difference ◽  
Before And After ◽  
Difference Test

ABSTRACT Objectives: To study the effect of water, halloumi cheese and sugar-free (SF) chewing gum on plaque pH recovery after the intake of sweetened PLAs. Settings and Design: A randomized clinical trial was conducted on 17 children (10 females, 7 males) aged 11–12 years with DFT/dft of more than 3. Materials and Methods: Each volunteer tested paracetamol and ibuprofen suspension alone or followed with water, halloumi cheese or SF gum, as well as 10% sucrose and 10% sorbitol as controls. Plaque pH was measured using the sampling method before and after 5, 10, 15, 20, 30 min of ingestion. Statistical Analysis: Statistical analysis was performed using analysis of variance followed by least significant difference test to assess minimum pH (min pH), maximum pH drop (ΔpH), and the area under baseline pH, and P value was set as 0.05. Results: Both ibuprofen and paracetamol were not significantly different from 10% sucrose in terms of min pH, ΔpH, and area under baseline pH except for min pH of ibuprofen (P = 0.034). Water and halloumi cheese did not have a significant effect on plaque pH recovery after the intake of both analgesics as min pH, ΔpH, and area under baseline pH were similar to 10% sucrose except for min pH of ibuprofen + water (P = 0.048). However, plaque pH variables after chewing SF gum for 20 min were similar to 10% sorbitol. Conclusion: Chewing SF gum immediately after the intake of sweetened PLAs for 20 min restores plaque pH and could be recommended as a complementary aid in caries prevention.

Cost-Effectiveness through the Dental-Health FRAMM Guideline for Caries Prevention among 12- to 15-Year-Olds in Sweden

2019 ◽  
Vol 53 (3) ◽  
pp. 339-346 ◽  
Author(s):  
Eva-Karin Bergström ◽  
Thomas Davidson ◽  
Ulla Moberg Sköld
Keyword(s):  
Cost Effectiveness ◽  
Dental Health ◽  
Caries Prevention ◽  
Caries Prevalence ◽  
School Based ◽  
Caries Increment ◽  
Dental Records ◽  
Caries Lesions ◽  
Approximal Caries ◽  
Approximal Surfaces

Since 2008, FRAMM has been a guideline for caries prevention for all 3- to 15-year-olds in the Västra Götaland Region in Sweden and a predominant part is school-based fluoride varnish applications for all 12- to 15-year-olds. The aims were to evaluate dental health-economic data among 12- to 15-year-olds, based on the approximal caries prevalence at the age of 12, and to evaluate cost-effectiveness. Caries data for 13,490 adolescents born in 1993 who did not take part and 11,321 adolescents born in 1998 who followed this guideline were extracted from dental records. Those with no dentin and/or enamel caries lesions and/or fillings on the approximal surfaces were pooled into the “low” subgroup, those with 1–3 into the “moderate” subgroup and those with ≥4 into the “high” subgroup. The results revealed that the low subgroup had a low approximal caries increment compared with the moderate and high subgroups during the 4-year study period. In all groups, there were statistically significant differences between those who took part in the guideline and those who did not. The analysis of cost-effectiveness revealed the lowest incremental cost-effectiveness ratio (ICER) for the high subgroup for decayed and/or filled approximal surfaces (DFSa) and approximal enamel lesions together and the highest ICER for the low subgroup for DFSa alone. To conclude, the FRAMM Guideline reduced the caries increment for adolescents with low, moderate and high approximal caries prevalence. The subgroup with the most favourable cost-effectiveness comprised those with a high caries prevalence at the age of 12.

scholarly journals Effect of Casein Phosphopeptide Amorphous Calcium Phosphate and Xylitol Chewing Gums, and Probiotic Yogurt on Periodontal Parameters: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Maryam Mehrabkhani ◽  
Iman Parisay ◽  
Niayesh Mastoory ◽  
Vajihe Barati Doghai
Keyword(s):  
Clinical Trial ◽  
Calcium Phosphate ◽  
Randomized Clinical Trial ◽  
Amorphous Calcium Phosphate ◽  
Dental Students ◽  
Chewing Gum ◽  
Probiotic Yogurt ◽  
Chewing Gums ◽  
Casein Phosphopeptide ◽  
Non Parametric

Objectives: This study aimed to assess the effect of casein phosphopeptide amorphous calcium phosphate (CPP-ACP) and xylitol chewing gums, and probiotic yogurt, as chemical plaque control strategies, on periodontal parameters. Materials and Methods: This randomized clinical trial evaluated 120 eligible dental students that were randomly divided into four groups (n=30) for use of (I) CPP-ACP chewing gum, (II) xylitol chewing gum, (III) probiotic yogurt, and (IV) chlorhexidine (CHX) mouthwash. The oral hygiene index-simplified (OHI-S), Silness and Loe gingival index (GI), and Silness and Loe modified plaque index (PI) were measured before and on days 15 and 30 after using the products. Paired t-test or its non-parametric equivalent was used to analyze the parameters after the intervention compared with baseline. The study groups were compared using one-way ANOVA or its non-parametric equivalent. Results: The OHI-S did not change over time, and most participants had a good OHI-S. The CHX group had the most favorable, and the probiotic yogurt group had the least favorable GI. Pairwise comparisons of the groups did not reveal a significant difference in GI between the CPP-ACP gum and CHX groups (P>0.05). CHX caused the greatest improvement in PI, with significant differences with other groups. Conclusion: CHX was the most effective for improvement of periodontal parameters followed by CPP-ACP, which showed better results compared with other groups.

Compliance in a school-based caries clinical trial of a sugar-free chewing gum

2011 ◽  
Vol 32 (4) ◽  
pp. 492-497 ◽  
Author(s):  
Denise Louise Bailey ◽  
Adèle Christine Campain ◽  
Claudine Elizabeth Tsao ◽  
Geoffrey Grant Adams ◽  
Wendy Joy Thomson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chewing Gum ◽  
School Based

Study of technological characteristics of the Health in gum® base for chewing gum

2020 ◽  
pp. 18-21
Author(s):  
E. Blynskaya ◽  
S. Tishkov ◽  
V. Bueva ◽  
K. Alekseev ◽  
V. Alekseev ◽  
...  
Keyword(s):  
Dosage Form ◽  
Patent Protection ◽  
Chewing Gum ◽  
Direct Compression ◽  
Technological Properties ◽  
Technological Characteristics ◽  
Chewing Gums

Medicated chewing gum is a convenient dosage form that allows to expand the range of medicines, ensure adherence of patients to the treatment and extend patent protection for well-known names of medicines. This article describes the technological properties of the Health in Gum® chewing gum base, which provides medicinal chewing gums with minimal addition of excipients by direct compression.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

scholarly journals Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Severe Sepsis ◽  
Plasma Volume ◽  
Volume Replacement ◽  
Efficacy And Safety ◽  
Volume Responsiveness ◽  
Double Blind ◽  
Link Type ◽  
Icu Discharge

Abstract Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.

scholarly journals Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mojca Jensterle ◽  
Simona Ferjan ◽  
Tadej Battelino ◽  
Jernej Kovač ◽  
Saba Battelino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neural Response ◽  
Taste Perception ◽  
Taste Bud ◽  
Controlled Clinical Trial ◽  
Food Cues ◽  
Link Type ◽  
Visual Food Cues ◽  
Taste Bud Cells

Abstract Background Preclinical studies demonstrated that glucagon-like peptide 1 (GLP-1) is locally synthesized in taste bud cells and that GLP-1 receptor exists on the gustatory nerves in close proximity to GLP-1-containing taste bud cells. This local paracrine GLP-1 signalling seems to be specifically involved in the perception of sweets. However, the role of GLP-1 in taste perception remains largely unaddressed in clinical studies. Whether any weight-reducing effects of GLP-1 receptor agonists are mediated through the modulation of taste perception is currently unknown. Methods and analysis This is an investigator-initiated, randomized single-blind, placebo-controlled clinical trial. We will enrol 30 women with obesity and polycystic ovary syndrome (PCOS). Participants will be randomized in a 1:1 ratio to either semaglutide 1.0 mg or placebo for 16 weeks. The primary endpoints are alteration of transcriptomic profile of tongue tissue as changes in expression level from baseline to follow-up after 16 weeks of treatment, measured by RNA sequencing, and change in taste sensitivity as detected by chemical gustometry. Secondary endpoints include change in neural response to visual food cues and to sweet-tasting substances as assessed by functional MRI, change in body weight, change in fat mass and change in eating behaviour and food intake. Discussion This is the first study to investigate the role of semaglutide on taste perception, along with a neural response to visual food cues in reward processing regions. The study may identify the tongue and the taste perception as a novel target for GLP-1 receptor agonists. Ethics and disseminations The study has been approved by the Slovene National Medical Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in an international peer-reviewed scientific journal. Trial registration ClinicalTrials.govNCT04263415. Retrospectively registered on 10 February 2020

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