Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial

2019 ◽  
Vol 98 (13) ◽  
pp. 1497-1502 ◽  
Author(s):  
M.C. Peters ◽  
A.R. Hopkins ◽  
L. Zhu ◽  
Q. Yu
Keyword(s):  
Clinical Trial ◽  
Disease Process ◽  
Primary Outcome Measure ◽  
Long Term Results ◽  
Tooth Surface ◽  
Controlled Clinical Trial ◽  
Posterior Teeth ◽  
Resin Infiltration ◽  
Proximal Lesion ◽  
High Caries Risk

This study reports 3-y outcomes of a split-mouth randomized clinical trial. Resin infiltration’s capacity to arrest caries lesion progression in noncavitated proximal lesions is affirmed. Forty-two consented young adults, blinded to tooth surface allocation, were treated with resin infiltration on 1 randomly selected surface and concurrently experienced a mock infiltration procedure on another. Both treatments were provided as an adjunct to the currently accepted standard-of-care regimen (periodic prophylaxis and serial fluoride varnish applications) appropriate for the management of high caries risk. Challenging periods of low oral hygiene compliance were expected. The primary outcome measure was 3-y radiographic lesion progression. Blinded investigators evaluated each study surface for lesion progression with a series of images obtained at intervals over the 3-y course of study. Proportions of progressing lesions were compared with McNemar’s test. Twenty-nine noncavitated lesion pairs in permanent posterior teeth demonstrating caries penetrating into inner enamel or outer dentin were included in the analyses. No adverse events were reported. Radiographic progression was recorded in 4 of 29 infiltrated lesions (14%) and 14 of 29 control lesions (48%, P < .003). Adjunct resin infiltration demonstrated a high 3-y efficacy of 71% (relative risk reduction). The prevented fraction was 86% for infiltration versus 52% for controls. Resin infiltration was 100% successful in arresting caries progression in inner enamel lesions (E2) and 64% in outer dentin lesions (D1). Supplementary microinvasive resin infiltration is significantly more efficacious in reducing proximal lesion progression than management by standard noninvasive therapy alone. Long-term results may shed light on whether this represents the arrest or delay of the caries disease process (ClinicalTrials.gov NCT01584024).

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals The use of ablative lasers in the treatment of facial melasma

2013 ◽  
Vol 88 (2) ◽  
pp. 238-242 ◽  
Author(s):  
Orlando Oliveira de Morais ◽  
Érica Freitas Lima Lemos ◽  
Márcia Carolline dos Santos Sousa ◽  
Ciro Martins Gomes ◽  
Izelda Maria Carvalho Costa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Short Pulse ◽  
Case Series ◽  
Long Term Results ◽  
Controlled Clinical Trial ◽  
Level Of Evidence ◽  
Short Pulse Duration ◽  
Treatment Regimens ◽  
Postinflammatory Hyperpigmentation

Melasma represents a pigmentary disorder that is difficult to treat. This study aims to broadly review the use of ablative lasers (Er:YAG and CO2) in the treatment of melasma, presenting the level of evidence of studies published to date. A total of 75 patients were enrolled in four case series studies (n=39), one controlled clinical trial (n=6) and one randomized controlled clinical trial (n=30). Studies on the Er:YAG laser showed better results with the use of short square-shaped pulses, which determined low rates of post-inflammatory hyperpigmentation and long-lasting maintenance of results. Likewise, studies on the CO2 laser proved the benefits of short pulse duration along with low-density energy. Post-treatment maintenance with the use of antipigmenting creams was necessary and effective to sustain long-term results. Ablative lasers may represent another useful and effective tool against melasma. Postinflammatory hyperpigmentation and difficulty in sustaining long-term results still represent the main limitations to a broader use of ablative lasers. Based on actual evidence, the use of this technology should be restricted to patients with recalcitrant disease. Further studies will help establish optimal laser parameters and treatment regimens.

Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind PlaceboControlled Clinical Trial

2020 ◽  
Vol 20 ◽  
Author(s):  
Mahshid Meysami ◽  
Mohammad Hashem Hashempur ◽  
Mohammad Kamalinejad ◽  
Majid Emtiazy
Keyword(s):  
Clinical Trial ◽  
Atopic Dermatitis ◽  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Malva Sylvestris ◽  
Topical Cream ◽  
Traditional Persian Medicine ◽  
Dermatologic Disease

Background: Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown anti‐ulcerogenic and anti‐inflammatory activity of this plant. Objectives: We designed a clinical trial to evaluate efficacy of topical cream of M. sylvestris extract in management of children with AD. Methods: Fifty one children with AD were randomly enrolled in two arms of a randomized, double-blind, controlled clinical trial. They were treated by topical cream of M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure. Results: There was a significant improvement in the severity of participants’ dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively). Conclusion: According to the results of this clinical trial, it could be concluded that topical use of M. sylvestris extract cream was effective on the reduction of the AD symptoms in children.

scholarly journals Evaluation of a mouthrinse containing guava leaf extract as part of comprehensive oral care regimen- a randomized placebo-controlled clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Namratha Nayak ◽  
Jothi Varghese ◽  
Seema Shetty ◽  
Vinutha Bhat ◽  
Tejal Durgekar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Leaf Extract ◽  
Study Groups ◽  
Tooth Surface ◽  
Controlled Clinical Trial ◽  
Mouth Rinse ◽  
Time Intervals ◽  
Hygiene Measures ◽  
Significant Difference ◽  
Guava Leaf

Abstract Background The control of biofilm adherence on tooth surface has always been the keystone of periodontal therapeutic systems. However, prevalence of gingivitis suggest inadequacy of self-performed oral hygiene measures and need for adjunctive aid for mechanical plaque control. Oral rinses containing chlorhexidine, has been widely used however, with certain limitations. Herbal products have been used widely reflecting its action as alternative and complementary remedy. Hence, the purpose of the present study was to evaluate the antimicrobial and antioxidant efficacy of a Guava leaf extract based mouthrinse in patients with chronic generalized gingivitis as an adjunct to oral prophylaxis. Methods Sixty subjects (n = 20) in compliance with the inclusion criteria were randomly assigned to one of the 3 study groups i.e. Group A- 0.15%Guava mouth rinse, Group B- 0.2% Chlorhexidine (CHX) mouth rinse, Group C- Distilled water (placebo). All the participants received professional oral prophylaxis and were dispensed with experimental mouth rinses and instructed to use for period of 30 days. Clinical parameters such as gingival index, plaque index along with microbial colony forming units using plaque samples and antioxidant levels in saliva were estimated at baseline, 30 and 90 days’ time intervals. Results All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group. Although there was improvement in the antioxidant status in all study participants, yet there was no statistically significant difference observed. Conclusion Guava mouth rinse can be used as an empirical adjunct to professional oral prophylaxis owing to its multifactorial properties and favourable acceptance. However, long term studies need to be conducted to validate its use for an extended period of time. Trial registration The clinical trial has been prospectively registered on 17th February 2017 by the Clinical Trials Registry-India (CTRI/2017/02/007898).

Sign in / Sign up

Export Citation Format

Share Document