Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study
To assess the efficacy of Pro-Argin with respect to the oral health-related quality of life (OHRQoL) and cervical dentine hypersensitivity (CDH) in subjects with CDH for 24 weeks compared to a control group. Three study centers (one each in France, Germany, and Switzerland) included 273 subjects for...
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MDPI AG
2022-04-01
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| Online Access: | https://www.mdpi.com/2076-3417/12/9/4431 |
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| author | Mary Michaelis Constanze Hirsiger Dominique Roux Patrick Roger Schmidlin Thomas Attin Sophie Doméjean Christian Hirsch Christian Heumann Hans-Günter Schaller Christian Ralf Gernhardt |
| author_facet | Mary Michaelis Constanze Hirsiger Dominique Roux Patrick Roger Schmidlin Thomas Attin Sophie Doméjean Christian Hirsch Christian Heumann Hans-Günter Schaller Christian Ralf Gernhardt |
| author_sort | Mary Michaelis |
| collection | DOAJ |
| description | To assess the efficacy of Pro-Argin with respect to the oral health-related quality of life (OHRQoL) and cervical dentine hypersensitivity (CDH) in subjects with CDH for 24 weeks compared to a control group. Three study centers (one each in France, Germany, and Switzerland) included 273 subjects for 24 weeks. Patients with CDH involving at least two non-molar teeth and those with Schiff scores (cold air sensitivity scale) of 2 or 3 were included. The primary study parameter was a change in the OHRQoL from baseline to 24 weeks, as assessed by the Oral Health Impact Profile (OHIP)-49 questionnaire within and between the randomized groups. Patients were randomly assigned to the test group (TG) or the control group (CG). Prophylaxis paste and toothpaste in the TG contained 8% arginine and calcium carbonate. The toothpaste in the CG contained sodium monofluorophosphate. The level of significance was set at 5% (<i>p</i> = 0.05). The OHIP-49 at 24 weeks was analyzed using the analysis of covariance (ANCOVA). The mean OHIP-49 score after 24 weeks (adjusted for baseline) was significantly lower in the TG than in the CG (<i>p</i> = 0.005, ANCOVA). The OHIP-49 pain-related items adjusted for the baseline values also showed significant differences between the groups (<i>p</i> = 0.025, ANCOVA). The treatment over a period of 24 weeks using products based on the Pro-Argin technology showed a significant improvement in the OHRQoL compared to the placebo application. |
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| language | English |
| last_indexed | 2024-03-10T04:22:14Z |
| publishDate | 2022-04-01 |
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| record_format | Article |
| series | Applied Sciences |
| spelling | doaj.art-ba680735582b48fe94204a2a4dd0a4ee2023-11-23T07:48:57ZengMDPI AGApplied Sciences2076-34172022-04-01129443110.3390/app12094431Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter StudyMary Michaelis0Constanze Hirsiger1Dominique Roux2Patrick Roger Schmidlin3Thomas Attin4Sophie Doméjean5Christian Hirsch6Christian Heumann7Hans-Günter Schaller8Christian Ralf Gernhardt9Department of Operative Dentistry and Periodontology, University School of Dental Medicine, Martin-Luther-University of Halle-Wittenberg, Magdeburger Strasse 16, 06112 Halle (Saale), GermanyClinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zürich, Plattenstraße 33, 8032 Zürich, SwitzerlandService d’Odontologie, CHU de Clermont-Ferrand, University Clermont, UFR d’Odontologie, 49 Boulevard François Mitterrand CS 60032, 63001 Clermont-Ferrand, FranceClinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zürich, Plattenstraße 33, 8032 Zürich, SwitzerlandClinic of Conservative and Preventive Dentistry, Center of Dental Medicine, University of Zürich, Plattenstraße 33, 8032 Zürich, SwitzerlandUFR d’Odontologie, Centre de Recherche en Odontologie Clinique EA 4847, University Clermont Auvergne, Rue de Braga 2, 63000 Clermont-Ferrand, FranceDepartment of Pediatric Dentistry, University School of Dentistry, Liebigstraße 10-14, 04103 Leipzig, GermanyDepartment of Statistics, Ludwig-Maximilian-University, Ludwigstrasse 33, 80539 Munich, GermanyDepartment of Operative Dentistry and Periodontology, University School of Dental Medicine, Martin-Luther-University of Halle-Wittenberg, Magdeburger Strasse 16, 06112 Halle (Saale), GermanyDepartment of Operative Dentistry and Periodontology, University School of Dental Medicine, Martin-Luther-University of Halle-Wittenberg, Magdeburger Strasse 16, 06112 Halle (Saale), GermanyTo assess the efficacy of Pro-Argin with respect to the oral health-related quality of life (OHRQoL) and cervical dentine hypersensitivity (CDH) in subjects with CDH for 24 weeks compared to a control group. Three study centers (one each in France, Germany, and Switzerland) included 273 subjects for 24 weeks. Patients with CDH involving at least two non-molar teeth and those with Schiff scores (cold air sensitivity scale) of 2 or 3 were included. The primary study parameter was a change in the OHRQoL from baseline to 24 weeks, as assessed by the Oral Health Impact Profile (OHIP)-49 questionnaire within and between the randomized groups. Patients were randomly assigned to the test group (TG) or the control group (CG). Prophylaxis paste and toothpaste in the TG contained 8% arginine and calcium carbonate. The toothpaste in the CG contained sodium monofluorophosphate. The level of significance was set at 5% (<i>p</i> = 0.05). The OHIP-49 at 24 weeks was analyzed using the analysis of covariance (ANCOVA). The mean OHIP-49 score after 24 weeks (adjusted for baseline) was significantly lower in the TG than in the CG (<i>p</i> = 0.005, ANCOVA). The OHIP-49 pain-related items adjusted for the baseline values also showed significant differences between the groups (<i>p</i> = 0.025, ANCOVA). The treatment over a period of 24 weeks using products based on the Pro-Argin technology showed a significant improvement in the OHRQoL compared to the placebo application.https://www.mdpi.com/2076-3417/12/9/4431cervical dentine hypersensitivityPro-Arginquality of lifepatient health questionnaire |
| spellingShingle | Mary Michaelis Constanze Hirsiger Dominique Roux Patrick Roger Schmidlin Thomas Attin Sophie Doméjean Christian Hirsch Christian Heumann Hans-Günter Schaller Christian Ralf Gernhardt Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study Applied Sciences cervical dentine hypersensitivity Pro-Argin quality of life patient health questionnaire |
| title | Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study |
| title_full | Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study |
| title_fullStr | Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study |
| title_full_unstemmed | Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study |
| title_short | Impact of Pro-Argin on the Oral Health-Related Quality of Life: A 24-Week Randomized, Parallel-Group, Multicenter Study |
| title_sort | impact of pro argin on the oral health related quality of life a 24 week randomized parallel group multicenter study |
| topic | cervical dentine hypersensitivity Pro-Argin quality of life patient health questionnaire |
| url | https://www.mdpi.com/2076-3417/12/9/4431 |
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