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Article

Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

by
Alessandro Di Minno
1,2,*,†,
Hammad Ullah
1,†,
Lorenza Francesca De Lellis
1,
Daniele Giuseppe Buccato
1,
Alessandra Baldi
1,
Paola Cuomo
3,
Hesham R. El-Seedi
4,
Shaden A. M. Khalifa
5,
Xiang Xiao
6,
Roberto Piccinocchi
7,
Gaetano Piccinocchi
8,
Roberto Sacchi
9 and
Maria Daglia
1,10,*
1
Department of Pharmacy, University of Naples “Federico II”, Via D. Montesano 49, 80131 Naples, Italy
2
CEINGE-Biotecnologie Avanzate, Via Gaetano Salvatore 486, 80145 Naples, Italy
3
Department of Agriculture, University of Naples “Federico II”, Via Università 100, 80055 Naples, Italy
4
Department of Chemistry, Faculty of Science, Islamic University of Madinah, Madinah 42351, Saudi Arabia
5
Psychiatry and Psychology Department, Capio Saint Göran’s Hospital, Sankt Göransplan 1, 112 19 Stockholm, Sweden
6
School of Food and Biological Engineering, Jiangsu University, Zhenjiang 212013, China
7
Level 1 Medical Director Anaesthesia and Resuscitation Azienda Universitaria Ospedaliera Vanvitelli, Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138 Naples, Italy
8
Comegen Azienda Universitaria Ospedaliera Vanvitelli, Società Cooperativa Sociale di Medici di Medicina Generale, Viale Maria Bakunin 41, 80125 Naples, Italy
9
Applied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, Viale Taramelli 24, 27100 Pavia, Italy
10
International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China
*
Authors to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Nutrients 2024, 16(6), 862; https://doi.org/10.3390/nu16060862
Submission received: 5 February 2024 / Revised: 12 March 2024 / Accepted: 13 March 2024 / Published: 16 March 2024
(This article belongs to the Section Phytochemicals and Human Health)
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Abstract

Preclinical studies have shown that the combination of Cistus × incanus L. and Scutellaria lateriflora L. extracts exerts beneficial effects on oral health against gingivitis. Thus, this study aimed to assess the tolerability of a chewing gum and its efficacy on gingivitis in a double-blind, placebo-controlled clinical trial. Enrolled subjects (n = 60, 18–70 years) were randomized to receive two chewing gums or a placebo daily for 3 months. At baseline (t0) and monthly (t1, t2, and t3) timepoints, the Quantitative Gingival Bleeding Index (QGBI), the Modified Gingival Index (MGI), and the Oral Health 15 items (OH-15)] were employed to assess potential improvements in gingivitis. Pain was self-quantified via the Visual Analogue Scale (VAS), and the Clinical Global Impression Scale for Severity of illness (CGI-S) helped in evaluating the oral general conditions. This study is listed on the ISRCTN registry. At t3, the QGBI, MGI, OH-15, VAS, and CGI-S values decreased in the treated but not in the placebo group (β = 0.6 ± 0.1, t176 = 3.680, p < 0.001; β = 0.87 ± 0.21, t115 = 4.263, p < 0.001; β = 5.3 ± 2.5, t172 = 2.086, p = 0.038; β = 3.16 ± 0.51, t88 = 6.253, p < 0.001; and β = 1.09 ± 0.32, t83 = 3.419, p < 0.001, respectively). A significant improvement in gingival health occurred after a 3-month intervention with the chewing gums containing S. lateriflora and C. incanus extracts.
Keywords: Scutellaria lateriflora L.; Cistus × incanus L.; gingivitis; chewing gum; randomized clinical trial Scutellaria lateriflora L.; Cistus × incanus L.; gingivitis; chewing gum; randomized clinical trial

Share and Cite

MDPI and ACS Style

Di Minno, A.; Ullah, H.; De Lellis, L.F.; Buccato, D.G.; Baldi, A.; Cuomo, P.; El-Seedi, H.R.; Khalifa, S.A.M.; Xiao, X.; Piccinocchi, R.; et al. Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients 2024, 16, 862. https://doi.org/10.3390/nu16060862

AMA Style

Di Minno A, Ullah H, De Lellis LF, Buccato DG, Baldi A, Cuomo P, El-Seedi HR, Khalifa SAM, Xiao X, Piccinocchi R, et al. Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2024; 16(6):862. https://doi.org/10.3390/nu16060862

Chicago/Turabian Style

Di Minno, Alessandro, Hammad Ullah, Lorenza Francesca De Lellis, Daniele Giuseppe Buccato, Alessandra Baldi, Paola Cuomo, Hesham R. El-Seedi, Shaden A. M. Khalifa, Xiang Xiao, Roberto Piccinocchi, and et al. 2024. "Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial" Nutrients 16, no. 6: 862. https://doi.org/10.3390/nu16060862

APA Style

Di Minno, A., Ullah, H., De Lellis, L. F., Buccato, D. G., Baldi, A., Cuomo, P., El-Seedi, H. R., Khalifa, S. A. M., Xiao, X., Piccinocchi, R., Piccinocchi, G., Sacchi, R., & Daglia, M. (2024). Efficacy and Tolerability of a Scutellaria lateriflora L. and Cistus × incanus L.-Based Chewing Gum on the Symptoms of Gingivitis: A Monocentric, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients, 16(6), 862. https://doi.org/10.3390/nu16060862

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