USE OF MAGNESIUM HYDRIDE IN PREPARATION OF COMPOSITION FOR PREVENTING AND TREATING CHRONIC PERIODONTITIS, AND MAGNESIUM HYDRIDE TOOTHPASTE

Abstract

The-use of magnesium hydride in the preparation of a composition for preventing and treating chronic periodontitis, and a magnesium hydride toothpaste are provided. In the composition or the magnesium hydride toothpaste, magnesium hydride has a weight percentage of 1% to 3%. The toothpaste has the functions of disinfection, anti-inflammation, anti-oxidation, removing tooth stains, improving bad breath, alleviating gingival swelling, bleeding, and recession, and improving periodontitis symptoms. An appropriate amount of magnesium hydride fine particles is added in toothpaste, and the magnesium hydride particles can be hydrolyzed into hydrogen and magnesium ions with anti-inflammatory effects, which can also inhibit alveolar bone resorption. The magnesium hydride-containing composition is safe in use, and can effectively prevent the occurrence and development of periodontal diseases after long-term use.

Claims

1. A preparation method of a composition for preventing and treating chronic periodontitis, comprising preparing the composition by use of magnesium hydride, wherein in the composition, the magnesium hydride has a weight percentage of 1% to 3%.

2. The preparation method according to claim 1, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

3. A preparation method of a toothpaste, comprising preparing the composition by use of magnesium hydride, wherein in the toothpaste, the magnesium hydride has a weight percentage of 1% to 3%.

4. The preparation method according to claim 3, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

5. A magnesium hydride toothpaste, comprising 15 wt % to 51 wt % of glycerin and/or paraffin oil, 0 wt % to 30 wt % of 1,2-propanediol, 42 wt % to 45 wt % of calcium carbonate, 2 wt % to 5 wt % of silicon dioxide, 0 wt % to 3 wt % of sodium dodecyl sulfate (SDS), 1 wt % to 3 wt % of magnesium hydride, 0 wt % to 1 wt % of sodium carboxymethyl cellulose (CMC-Na), 0 wt % to 0.3 wt % of xanthan gum, 0 wt % to 3 wt % of polyvinylpyrrolidone (PVP), and 0 wt % to 1 wt % of peppermint powder.

6. The magnesium hydride toothpaste according to claim 5, comprising 51 wt % of the glycerin, 42 wt % of the calcium carbonate, 2 wt % of the silicon dioxide, 3 wt % of the SDS, 1 wt % of the magnesium hydride, and 1 wt % of the peppermint powder.

7. The magnesium hydride toothpaste according to claim 5, comprising 33.4 wt % of the paraffin oil, 14.3 wt % the glycerin, 43 wt % of the calcium carbonate, 2 wt % of the silicon dioxide, 3 wt %% of the SDS, 1 wt %% of the CMC-Na, 0.3 wt %% of the xanthan gum, 2 wt %% of the magnesium hydride, and 1 wt %% of the peppermint powder.

8. The magnesium hydride toothpaste according to claim 5, comprising 29 wt %% of the 1,2-propanediol, 15 wt %% of the glycerin, 44 wt %% of the calcium carbonate, 5 wt %% of the silicon dioxide, 3 wt %% of the PVP, 3 wt %% of the magnesium hydride, and 1 wt %% of the peppermint powder.

9. The magnesium hydride toothpaste according to claim 5, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

10. The magnesium hydride toothpaste according to claim 6, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

11. The magnesium hydride toothpaste according to claim 7, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

12. The magnesium hydride toothpaste according to claim 8, wherein the magnesium hydride has a particle size of 0.1 μm to 100 μm.

Description

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0034] The present disclosure is described in detail below with reference to specific examples. The following examples will help those skilled in the art to further understand the present disclosure, but do not limit the present disclosure in any way. It should be noted that those of ordinary skill in the art can further make several variations and improvements without departing from the idea of the present disclosure. These all fall within the protection scope of the present disclosure.

[0035] It should be noted that, in examples, when a particle size of magnesium hydride is in the range of 0.1 μm to 100 μm, a prepared magnesium hydride toothpaste can have similar effects to the following examples.

EXAMPLE 1

[0036] Toothpaste was prepared from the following components in weight percentage: glycerin: 51%, calcium carbonate: 42%, silicon dioxide: 2%, SDS: 3%, magnesium hydride (with a particle size of 10 μm to 30 μm): 1%, and peppermint powder: 1%.

[0037] The toothpaste was prepared as follows:

[0038] The magnesium hydride was composed of MgH.sub.2 compound particles with a particle size of 0.1 μm to 100 μm. The toothpaste can be prepared by a traditional toothpaste preparation process. Specifically, the magnesium hydride toothpaste in this example was prepared as follows: the above components were weighed, and dispersed and mixed in a pre-dispersion kettle to obtain a liquid material, and a vacuum pump of a paste preparation kettle was turned on to pump the liquid material into the paste preparation kettle; then a scraper, a stirrer, and a colloid mill were turned on; 50 min later, the colloid mill, the stirrer, and the scraper were turned off sequentially, and vacuum breaking was conducted to obtain the magnesium hydride toothpaste; and samples were collected for test.

EXAMPLE 2

[0039] Toothpaste was prepared from the following components in weight percentage: paraffin oil: 33.4%, glycerin: 14.3%, calcium carbonate: 43%, silicon dioxide: 2%, SDS: 3%, CMC-Na: 1%, xanthan gum: 0.3%, magnesium hydride (with a particle size of 10 μm to 30 μm): 2%, and peppermint powder: 1%.

[0040] The magnesium hydride toothpaste in Example 2 was prepared according to the preparation method in Example 1.

EXAMPLE 3

[0041] Toothpaste was prepared from the following components in weight percentage: 1,2-propanediol: 29%, glycerin: 15%, calcium carbonate: 44%, silicon dioxide: 5%, PVP: 3%, magnesium hydride (with a particle size of 10 μm to 30 μm): 3%, and peppermint powder: 1%.

[0042] The magnesium hydride toothpaste in Example 3 was prepared according to the preparation method in Example 1.

[0043] As magnesium hydride is added, the toothpaste of the present disclosure has the effects of anti-oxidation, removing tooth stains and whitening, and effectively inhibiting inflammation, shows high stability, and can effectively prevent and alleviate a series of clinical symptoms caused by periodontitis.

Comparative Example 1

[0044] Toothpaste was prepared from the following components in weight percentage: glycerin: 51%, calcium carbonate: 43%, silicon dioxide: 2%, SDS: 3%, and peppermint powder: 1%.

[0045] The toothpaste was prepared by the same process as in Example 1.

Comparative Example 2

[0046] Toothpaste was prepared from the following components in weight percentage: glycerin: 51%, calcium carbonate: 42.5%, silicon dioxide: 2%, SDS: 3%, magnesium hydride (with a particle size of 10 μm to 30 μm): 0.5%, and peppermint powder: 1%.

[0047] The toothpaste was prepared by the same process as in Example 1.

Effectiveness verification:

I. Determination of Concentrations of Hydrogen and Magnesium Ions Released from the Magnesium Hydride Toothpaste

[0048] 1. Experimental method

[0049] 1.1 Materials: the magnesium hydride toothpaste of Examples 1 to 3 (several toothbrushes, hydrogen measuring instrument (ENT2000, Ltd. Japan), ultrasonic instrument, water, several small glass cups (15 ml in volume), ICP-AES analyzer (atomic emission spectrometer, USA).

[0050] 1.2 Experimental steps: [0051] 1) The magnesium hydride toothpaste was applied to a toothbrush. [0052] 2) The toothbrush was placed in a small glass cup with 5 ml of water to apply the toothpaste on a glass wall. [0053] 3) The small glass cup was placed in the ultrasonic instrument for 1 min to promote the dissolution of the toothpaste, then taken out, and stood at room temperature. [0054] 4) The hydrogen measuring instrument was used to detect hydrogen concentrations when the small glass cup stood for 1 min and 3 min. [0055] 5) ICP-AES was used to detect a magnesium ion concentration. [0056] 6) Five replicates were set for each example, and results were expressed as mean ± standard deviation (SD).

[0057] 2. Test results of hydrogen and magnesium ion concentrations were shown in Table 1.

TABLE-US-00001 TABLE 1 Hydrogen Hydrogen Magnesium ion concentration concentration concentration Sample at 1 min (ppb) at 3 min (ppb) (ppm) Magnesium hydride 900 1100 5.0 toothpaste of Example 1 Magnesium hydride 950 1200 7.7 toothpaste of Example 2 Magnesium hydride 990 1400 10.0 toothpaste of Example 3

[0058] 3. Conclusion: The magnesium hydride toothpaste can produce high concentrations of hydrogen and magnesium ions.

II. Research on Treatment of Magnesium Hydride Toothpaste for Patients with Chronic Periodontitis

[0059] (1) Clinical Utility of Example 1

[0060] 50 subjects were recruited.

[0061] Toothpaste formula used: the formula described in Example 1 (glycerin+magnesium hydride).

[0062] Inclusion criteria: well overall health status, no important systemic diseases, and age: 18 to 60 years old.

[0063] Exclusion criteria: open dental caries or mucosal lesions in the oral cavity, and severe periodontitis.

[0064] Usage: brushing frequency: 2 times/day; toothpaste dosage: 2 g/time; and brushing time: 3 min/time. The toothpaste was continuously used for 30 d.

[0065] Organization unit: Dental Clinic of Jiading District, Shanghai. The experiment was approved by the Ethics Committee.

[0066] After the experiment, a questionnaire was conducted for the participants. The effect feedback obtained was shown in Table 2.

TABLE-US-00002 TABLE 2 Utility feedback of the magnesium hydride toothpaste in Example 1 Almost Completely Prominent General none none (number of (number of (number of (number of subjects) subjects) subjects) subjects) Cleaning power 38 11 1 0 Improvement on 19 18 10 3 gingival bleeding Improvement on 22 21 6 1 gingival swelling Improvement on 37 6 5 2 bad breath

[0067] 2. Experimental subject:

[0068] Inclusion criteria: those who are at an age of 18 to 60 and diagnosed with chronic periodontitis through clinical examination (with reference to the diagnostic criteria of chronic periodontitis proposed by American Periodontal Disease Classification Symposium in 1999), have at least 18 completely-erupted teeth in the oral cavity and 4 or more sites with a periodontal pocket depth of 6 mm to 9 mm in at least 2 quadrants of the oral cavity, and are willing to sign an informed consent form, and voluntarily and able to ensure follow-up, reexamination, and treatment in accordance with a research schedule within a specified time period.

[0069] Exclusion criteria: smokers, alcohol abusers, and drug abusers; those who have received antibiotic treatment or periodontal sequential treatment in recent 3 months; those who have uncontrolled diabetes, hypertension, and other systemic diseases that cannot tolerate periodontal sequential treatment; those with acute symptoms; those who are taking drugs that affect the periodontal condition (glucocorticoids, phenytoin, nifedipine, cyclosporine A, etc.); and those who are pregnant or breastfeeding or intended for conception during a planned treatment period.

[0070] The ethics committee approved. The patients signed an informed consent form.

[0071] Intervention and clinical examination

[0072] The 5 groups of patients all accepted oral hygiene education and ultrasonic supragingival scaling. One week later, the periodontal clinical indexes (baseline level) were checked, then SRP was conducted with a subgingival curette, and the periodontal pocket and root surface were checked to confirm that the root surface was fully cleaned and smoothed. The 5 groups of patients brushed their teeth with a special toothbrush (provided by the dental clinic) and a corresponding toothpaste according to a correct tooth brushing method recommended. All included patients underwent a comprehensive periodontal clinical examination 1 week (baseline), 6 weeks, and 12 weeks after the supragingival scaling. Clinical examination indexes included: probing pocket depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP).

[0073] 3. Conclusion: The toothpaste with 1% magnesium hydride can effectively improve gingival bleeding, gingival swelling, and bad breath.

[0074] (2) Clinical Utility of Example 2

[0075] 50 subjects were recruited.

[0076] Inclusion criteria: well overall health status, no important systemic diseases, and age: 18 to 60 years old.

[0077] Exclusion criteria: open dental caries or mucosal lesions in the oral cavity, and severe periodontitis.

[0078] Usage: brushing frequency: 2 times/day; toothpaste dosage: 2 g/time; and brushing time: 3 min/time. The toothpaste was continuously used for 30 d.

[0079] Organization unit: Dental Clinic of Jiading District, Shanghai. The experiment was approved by the Ethics Committee.

[0080] The effect feedback obtained was shown in Table 3.

TABLE-US-00003 TABLE 3 Utility feedback of the magnesium hydride toothpaste in Example 2 Almost Completely Prominent General none none Utility feedback of the (number (number (number (number magnesium hydride of of of of toothpaste in Example 2 subjects) subjects) subjects) subjects) Cleaning power 40 10 0 0 Improvement on 21 20 8 2 gingival bleeding Improvement on 23 21 5 1 gingival swelling Improvement on 39 4 5 2 bad breath

[0081] Conclusion: The toothpaste with 2% magnesium hydride can effectively improve gingival bleeding, gingival swelling, and bad breath.

[0082] (3) Clinical Utility of Example 3

[0083] 50 subjects were recruited.

[0084] Inclusion criteria: well overall health status, no important systemic diseases, and age: 18 to 60 years old.

[0085] Exclusion criteria: open dental caries or mucosal lesions in the oral cavity, and severe periodontitis.

[0086] Usage: brushing frequency: 2 times/day; toothpaste dosage: 2 g/time; and brushing time: 3 min/time. The toothpaste was continuously used for 30 d.

[0087] Organization unit: Dental Clinic of Jiading District, Shanghai. The experiment was approved by the Ethics Committee.

[0088] The effect feedback obtained was shown in Table 4.

TABLE-US-00004 TABLE 4 Utility feedback of the magnesium hydride toothpaste in Example 3 Completely Prominent General Almost none none (number of (number of (number of (number of subjects) subjects) subjects) subjects) Cleaning power 42 8 0 0 Improvement on 22 19 8 1 gingival bleeding Improvement on 25 19 5 1 gingival swelling Improvement on 41 5 3 1 bad breath

[0089] Conclusion: The toothpaste with 2% magnesium hydride can effectively improve gingival bleeding, gingival swelling, and bad breath.

[0090] According to the utility of Examples 1, 2, and 3, the magnesium hydride contents of 1% to 3% can lead to a significant effect, and toothpaste with the magnesium hydride contents all can effectively improve gingival bleeding, gingival swelling, and bad breath. There is no significant difference in utility among the three examples with the content of 1% to 3%.

[0091] (4) Clinical Trial Effects of the Comparative Example

[0092] Utility feedback of the toothpaste of Comparative Example 1 (without MgH.sub.2, corresponding to Example 1)

[0093] 50 subjects were recruited.

[0094] Inclusion criteria: well overall health status, no important systemic diseases, and age: 18 to 60 years old.

[0095] Exclusion criteria: open dental caries or mucosal lesions in the oral cavity, and severe periodontitis.

[0096] Results were shown in Table 5.

TABLE-US-00005 TABLE 5 Utility feedback of the magnesium hydride toothpaste in Comparative Example 1 Almost Completely Prominent General none none (number (number (number (number of of of of subjects) subjects) subjects) subjects) Cleaning power 37 12 1 0 Improvement on 1 5 29 15 gingival bleeding Improvement on 1 3 31 15 gingival swelling Improvement on 0 5 27 18 bad breath

[0097] Conclusion: The toothpaste without magnesium hydride (the remaining components are the same as in Example 1) shows a prominent oral cleaning effect on the subjects, but cannot significantly improve gingival bleeding, gingival swelling, and bad breath. In contrast to the utility of Example 1, it can be confirmed that the magnesium hydride in the toothpaste makes a significant contribution to improving gingival bleeding, gingival swelling, and bad breath.

III. Antibacterial Test of MgH.SUB.2 .Toothpaste

[0098] 1. Experimental purpose: testing the bactericidal activities of the 3 kinds of toothpastes with different magnesium hydride contents

[0099] 2. Experimental materials [0100] (1) Test samples: the magnesium hydride toothpaste prepared in Examples 1, 2, and 3, with magnesium hydride contents of 1%, 2%, and 3%, respectively; and the toothpaste prepared in Comparative Examples 1 and 2, with magnesium hydride contents of 0% and 0.5%, respectively (the remaining components were the same as in Example 1 to facilitate comparison with Example 1). [0101] (2) Test strains: Escherichia coli (E. coli) ATCC 8739; Staphylococcus aureus (S. aureus) ATCC 25923; and Candida albicans (C. albicans). [0102] (3) Media: LB medium (for the cultivation of E. coli and S. aureus); and YPD medium (for the cultivation of C. albicans).

3. Experimental Scheme

[0103] Single colonies were picked and inoculated into 2 mL of a liquid medium, and cultivated overnight; a bacterial concentration was adjusted with a corresponding medium to an OD.sub.600 of about 0.5, and then diluted 100 times with the medium to obtain a bacterial suspension for later use; 1 g of toothpaste or a control substance was weighed and added into the bacterial suspension (with 2 to 3 glass beads to disperse the toothpaste), and a resulting mixture was shaken to dissolve the toothpaste, stood for 3 min, and then was serially diluted with sterile normal saline; and counting was conducted for diluted samples by spot inoculation, and a bactericidal rate was calculated.

4. Experimental Results

[0104]

TABLE-US-00006 TABLE 6 Test results of bactericidal rate (%) E. coli S. aureus C. albicans 1% MgH.sub.2 toothpaste  60% 100% 100% (Example 1) 2% MgH.sub.2 toothpaste  93% 100% 100% (Example 2) 3% MgH.sub.2 toothpaste 100% 100% 100% (Example 3) Toothpaste of  0% 100% 100% Comparative Example 1 (with 0% MgH.sub.2) Toothpaste of  28% 100% 100% Comparative Example 2 (with 0.5% MgH.sub.2)

[0105] It can be seen from experimental results shown in Table 6 that, compared with the toothpaste in the control group 1 (without MgH.sub.2) and the control group 2 (low MgH.sub.2 content (0.5%)), the toothpaste of the present disclosure show significant bactericidal effects on common E. coli, S. aureus, and C. albicans; and the toothpaste in the control group 1 (without MgH.sub.2) and the control group 2 (low MgH.sub.2 content (0.5%)) have no significant bactericidal effect on E. coli.

[0106] Combining the above antibacterial experiment results and the actual feedback results of the 5 groups of clinical subjects, it can be confirmed that the toothpaste with magnesium hydride (1 wt % to 3 wt %) of the present disclosure has significant antibacterial effects, and can improve gingival bleeding and gingival swelling and eliminate bad breath.

[0107] There are many ways to specifically apply the present disclosure, and the above are merely preferred implementations of the present disclosure. It should be noted that the foregoing examples are provided only for illustrating the present disclosure and are not intended to limit the protection scope of the present disclosure. For a person of ordinary skill in the art, several improvements may further be made without departing from the principle of the present disclosure, and these improvements should also be considered as falling within the protection scope of the present disclosure.