Table Info

Table 2.

Local findings at palate, cheeks, tongue, and lips according to the World Health Organization (WHO) Oral Toxicity Scale [7]. The lysozyme group was treated with a spray containing lysozyme hydrochloride + cetylpyridinium chloride + lidocaine, control group was treated with a compounded preparation containing gentamicin sulfate + dexamethasone + lidocaine

Parameter	Baseline	After 7 days	After 14 days	After 21 days
Local findings—palate
Lysozyme group (n = 26)	G0: 1 (4); G1: 22 (85); G2: 2 (8); G3: 1 (4)	G0: 1 (4); G1: 22 (85); G2: 2 (8); G3: 1 (4)	G0: 1 (4); G1: 23 (88); G2: 2 (8); G3: 0 (0)	G0: 3 (12); G1: 19 (73); G2: 3 (12); G3: 1 (4)
Control group (n = 30)	G0: 2 (7); G1: 23 (77); G2: 5 (17); G3: 0 (0)	G0: 1 (3); G1: 28 (93); G2: 1 (3); G3: 0 (0)	G0: 3 (10); G1: 23 (77); G2: 4 (13); G3: 0 (0)	G0: 2 (7); G1: 21 (70); G2: 5 (17); G3: 2 (7)
p-value	0.868	0.367	0.980	0.363
Local findings—cheeks
Lysozyme group (n = 26)	G0: 19 (73); G1: 5 (19); G2: 1 (4); G3: 1 (4)	G0: 20 (77); G1: 5 (19); G2: 1 (4); G3: 0 (0)	G0: 21 (81); G1: 4 (15); G2: 1 (4); G3: 0 (0)	G0: 20 (77); G1: 3 (12); G2: 2 (8); G3: 1 (4)
Control group (n = 30)	G0: 21 (70); G1: 6 (20); G2: 3 (10); G3: 0 (0)	G0: 22 (73); G1: 7 (23); G2: 1 (3); G3: 0 (0)	G0: 22 (73); G1: 6 (20); G2: 2 (7); G3: 0 (0)	G0: 20 (67); G1: 4 (13); G2: 6 (20); G3: 0 (0)
p-value	0.804	0.777	0.503	0.408
Local findings—tongue
Lysozyme group (n = 26)	G0: 13 (50); G1: 10 (38); G2: 2 (8); G3: 1 (4)	G0: 18 (69); G1: 7 (27); G2: 1 (4); G3: 0 (0)	G0: 15 (58); G1: 8 (31); G2: 3 (12); G3: 0 (0)	G0: 16 (62); G1: 6 (23); G2: 3 (12); G3: 1 (4)
Control group (n = 30)	G0: 19 (63); G1: 8 (27); G2: 3 (10); G3: 0 (0)	G0: 16 (53); G1: 13 (43); G2: 1 (3); G3: 0 (0)	G0: 16 (53); G1: 10 (33); G2: 4 (13); G3: 0 (0)	G0: 12 (40); G1: 14 (47); G2: 4 (13); G3: 0 (0)
p-value	0.317	0.257	0.740	0.233
Local findings—lips
Lysozyme group (n = 26)	G0: 24 (92); G1: 1 (4); G2: 1 (4); G3: 0 (0)	G0: 25 (96); G1: 1 (4); G2: 0 (0); G3: 0 (0)	G0: 24 (92); G1: 1 (4); G2: 1 (4); G3: 0 (0)	G0: 24 (92); G1: 1 (4); G2: 0 (0); G3: 1 (4)
Control group (n = 30)	G0: 25 (83); G1: 4 (13); G2: 1 (3); G3: 0 (0)	G0: 26 (87); G1: 3 (10); G2: 1 (3); G3: 0 (0)	G0: 27 (90); G1: 2 (7); G2: 1 (3); G3: 0 (0)	G0: 27 (90); G1: 0 (0); G2: 3 (10); G3: 0 (0)
p-value	0.338	0.213	0.778	0.765

Data are presented as an absolute number (percentage of the total number of respondents in the subject group). Grade 0 (G0): healthy; Grade 1 (G1): soreness/erythema; Grade 2 (G2): erythema, ulcers, can eat solids; Grade 3 (G3): ulcers, requires liquid diet only [7]

Declarations

Author contributions

ZG, JR, and NG: Investigation, Writing—review & editing. AŠ: Conceptualization, Resources, Methodology, Supervision. MM: Conceptualization, Methodology, Supervision, Writing—original draft. ATA: Conceptualization, Writing—original draft. UG: Conceptualization, Data curation, Software, Formal analysis, Supervision, Visualization, Methodology, Writing—original draft. All authors approved the final version of the manuscript.

Conflicts of interest

Aziz Šukalo, Meliha Mehić, Amna Tanović Avdić, and Una Glamočlija disclose the following relationships—employees of Bosnalijek d.d., a pharmaceutical company producing lysozyme-based products.

Ethical approval

The study was registered with the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina under the protocol number LCS-OM-01. The clinical study was approved by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, number 08-07.5-6730-1/20 on July 20, 2020.

Consent to participate

Informed consent to participate in the study was obtained from all participants.

Consent to publication

Not applicable.

Availability of data and materials

The datasets generated for this study are available from the corresponding author upon reasonable request.

Funding

The authors declare that this study was supported by Bosnalijek d.d. (a company that is a producer of lysozyme-based products). Bosnalijek d.d. had a role in the design of the study; in the collection, analyses, and interpretation of data; in the writing of the manuscript, and in the decision to publish the results. The data and results of this study are not affected by the interest of the Bosnalijek d.d.

Copyright

Publisher’s note

Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.

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