Although customized health products are being released in large quantities to support the health of the busy modern people, the word ‘oral health’ is still questionable. Perceptions about the importance of health are increasing, but paradoxically, there is still a generous perception of oral health. Many studies have been done to add antibacterial or anti-plaque materials to existing toothpaste or mouthwash to maintain oral hygiene and prevent gum inflammation. Fluoride and various herbal extracts are currently used [1-3].

The most universally effective method for plaque removal is toothbrushing [4]. Compared with toothbrushing, the wind that was excluded is changing along with the flow of the times. Naturally, the efficacy of mouthwash has received attention, and it is desirable to use a supplemental oral hygiene product suitable for the individual [5].

Gingivitis is defined as inflammation that is limited to the soft tissues of the upper alveolar bone, and periodontitis [6] is a condition that causes further absorption of alveolar bone supporting tooth and destruction of deep tissue.

Further progress is made here, which destroys the alveolar bone and results in tooth dislodging and extraction [7]. Currently, three out of ten adults in Korea have periodontal disease that requires treatment [8], and to control and prevent periodontal disease, care must be taken to prevent plaque build-up on the tooth surface or to remove gingiva before inflammatory disease can occur [9]. In most countries, dental caries and periodontal disease account for a large proportion of chronic diseases [10], and this may affect the quality of life by restricting the maintenance of physical functions and social activities [11].

It focuses on comparing gingivitis preventive effects using basic ingredients such as a standard mouthwash containing only basic ingredients such as wetting agent, foaming agent, and fragrance, wetting agent, foaming agent and fragrance, and mouthwash containing sodium fluorophosphate and green tea extract, which are effective ingredients for cavity and periodontal disease prevention.

Today, mouthwash has expanded its spectrum to specific uses and users through custom development. But the most basic thing is that it is important to continually check for effective and efficient ingredients so that mouthwash can perform its essential performance and see how it affects your teeth. For this reason, this study aims to compare the effect of mouthwash, which contains a universal amount of sodium fluoride and green tea extract, on regular mouthwash through periodic gingival and periodontal indexing.

Green tea components can affect not only the cavity but also the prevention and improvement of gingivitis. Most components of green tea are catechin. Also important catechins are composed of EGCG [(-) - epigallocatechin -3-gallate], EGC [(-) - epigallocatechin], ECG [-] - epicatachine-3-gallate], EC [(-)- epicatechin] [12].

Recently, the mechanism of action against enamel has been investigated by combining the use of other sodium fluoride and sodium fluorophosphate, and the addition of sodium fluorophosphate and soluble calcium to improve the caries prevention effect of fluoride and to clarify the mechanism of action of fluoride [13,14] are being actively researched. In this study, we investigated whether gingivitis reduction effect of sodium monofluoroacetate and green tea extract was shown.

Therefore, in this study, after controlling wetting agent, foaming agent, we studied periodic observations and gingivitis index (papillary marginal attached [PMA] index) on the 8-week, Talbott, Mandel and Chiltonʼs gingivitis index and gingivitis prevention effect of sodium fluorophosphate and green tea extract based on oral examination index, and this is meaningful in that it provides prevention of cavity and periodontal disease through mouthwash, improvement of oral environment, and basic data to enable healthy teeth. In addition, clinical trials were conducted to confirm gingivitis reduction effects.

1. Subject

It will be announced on the internet and in writing by using the common internet information sharing cafe (Lemon Terrace-Cheonan City) and the rest room of the company in the business incubation center of Dankook University and the school bulletin board, and then general recruitment, recruitment staff and applicants were recruited on a first come.

Among the individuals who agreed to participate in this study and signed the written consent form, we selected adult males and females aged 20 to 60. Subjects who had at least 24 teeth with no restorations, who were brushing regularly more than twice a day, and those with mild to moderate gingivitis were selected as subjects.

The subjects were selected from among those who were 20 years old or older and 60 years old or younger who signed the consent form from January 1, 2018 to March 31, 2018, and those with moderate gingivitis symptoms.

The sex and age distribution of the subjects were as follows (Table 1).

Table 1 . Sex and age distribution of subjects

Sex		Age group
		Total	20s	30s	40s	50s
Total		60	15	15	15	15
Male		30	8	8	7	7
Female		30	7	7	8	8

The experimental mouthwash containing sodium fluorophosphate and green tea extract as main components and the control mouthwash containing only basic ingredients such as wetting agent, foaming agent and fragrance were used. The mouthwash main ingredients were as follows (Table 2).

Table 2 . Ingredients and content of dentifrice

Ingredient	Control group	Experimental group
Sodium fluorophosphate	-	0.76%
Green tea extract	-	0.04%

2. Method

DanKook University IRB (DKU 2017-11-003-002) approved.

During the 16-week period, subjects are assigned a random assignment number in the order they are registered. Depending on the random assignment number, the group to be assigned to the study is determined by a “computer generated random list” prepared by the researcher and an independent third party before the start of the test. The randomization method was 1:1 in the experimental group and the control group by the block randomization method.

The provided mouthwash should be used three times a day after breakfast, lunch, and after dinner. The mouthwash solution was applied for a total of 16 weeks by using a toothpaste and a toothbrush and then brushing the teeth using a rotating brush. The toothpaste was then rinsed with a toothbrush and then faded and spit into the mouth for about 1 minute (10 ml).

The gingival index (GI) of the Papillary Marginal Attached Index, Talbott, Mandel and Chilton was rated on a total of 6 occasions before, 3 day, 5 day, 4 weeks, 8 weeks, and 16 weeks after the mouthwash experiment. Observations, items, and analyzes were recorded in the case record.

As for the contents of the record, in the visit 1, by demographic survey, sex, date of birth and age were investigated. The survey of the medical history was surveyed through the interviews at visit 2. The history of surgical history including surgical operation was examined at the screening point, and we also investigated history, time of occurrence for current medical history, treatment period, persistence, and opinion of the researchers. Visits 3 (screening) examined history of smoking and drinking.

(1) Papillary marginal attached index: The gingivitis status of anterior gingiva was measured by the following criteria. The target teeth were 10 unit gingiva each centered on the five interdental papillae in the maxillary and mandibular central incisors, lateral incisors. After dividing into three parts of papillary gingiva, marginal gingiva, attached gingiva, canines, and the gingivitis was assessed as a total score using the Papillary Marginal Attached Index, which measures gingivitis by adding 1 gingivitis to each gingivitis and 0 gingivitis if there isn’t inflammation. The lowest point was from 0 point, and the highest point was 30 point.

(2) Gingival index of Talbott, Mandel and Chilton: The gingival index was measured by dividing buccal surface, the lingual surface, and the gingival margin surrounding tooth into a mesial, distal, and central gingivitis, respectively. The target teeth were selected as 16, 11, 26, 46, 31, and 36 teeth, and the lowest point was from 0 to the highest point was 18 points. The gingival index is obtained by dividing the sum of the measurements of each site by the number of teeth to be examined. The gingival index was rated as 0 point if no inflammation was present. In the measurement of the periodontal pockets, a slight gingivitis was defined as 1 point without bleeding, 2 as gingivitis with bleeding, and 3 as gingivitis at the time of spontaneous bleeding.

Experiment results were entered using Microsoft Office Excel 2016 (Microsoft, Redmond, WA, USA). Input data were analyzed using SPSS Statistics version 24.0 (IBM Co., Armonk, NY, USA) statistical program. At this time, intra-group comparisons were analyzed by paired t-test, and inter-group comparisons were analyzed by 2-sample t-test.

1. PMA index

The PMA index was 9.25 in the experimental group (C) and 9.21 in the control group (E) before the experiment. After 4 weeks, the experimental group (C) 6.96, the control group (E), and after 4 weeks and 8 weeks, the experimental group (C) was statistically significantly lower than the control group (E) (p<0.05).

The PMA index showed statistically significant difference in the experimental group after 4 weeks and after 8 weeks (p<0.05). In the experimental group, it was confirmed that the PMA index decreased significantly from the 4th week after the experiment (Table 3).

Table 3 . Changes of dental PMA index

Group	Base	3 d	5 d	4 wk	8 wk
Experimental group	9.25±1.78	9.14±1.56	8.46±1.84*	6.96±1.35*	7.46±1.64*
Control group	9.21±2.35	9.38±2.70	9.21±2.61	9.07±2.88	8.79±2.60
p-value*	0.938	0.689	0.221	0.001	0.025

Values are presented as mean±standard deviation.

*p<0.05 by paired t-test between base and after.

2. Gingival index results of Talbott, Mandel and Chilton (Gingival index)

Gingival index of Talbott, Mandel and Chilton was 2.00 in the experimental group (C) and 2.01 in the control group (E) before the experiment, the experimental group (C) was 1.80 and the control group (E) was 1.95 after 4 weeks, and decreased to 1.97 in the experimental group (C) and 1.97 in the experimental group (C) after 8 weeks. After 4 weeks and 8 weeks, the experi-mental group (C) was statistically significantly lower than the control group (E) (p<0.05).

As results of gingival index measurements, the experimental group showed a statistically significant difference from 4 weeks, 8 weeks (p<0.05). In the experimental group, there was a significant decrease in the gingival index from 4 weeks after the experiment to before the experiment (p<0.05) (Table 4).

Table 4 . Changes of dental Talbott, Mandel and Chilton gingival index

Group	Base	3 d	5 d	4 wk	8 wk
Experimental group	2.00±0.43	2.00±0.25	1.95±0.21	1.80±0.20*	1.82±0.20*
Control group	2.01±0.25	2.02±0.18	1.95±0.17	1.95±0.15	1.97±0.15
p-value*	0.910	0.736	0.912	0.002	0.003

Values are presented as mean±standard deviation.

*p<0.05 by paired t-test between base and after.

Gingivitis is the most common inflammatory gingival disease. It is an inflammatory process that affects the gingiva, a functional unit of periodontal tissue, beginning at dentogingival junction, and is a major cause of dental plaque [15].

How to prevent gingivitis is the most effective way to prevent gingivitis by removing the plaque at an early stage using gingivitis-preventive mouthwash, with proper toothbrushing. Various studies have been carried out to prevent oral diseases. Among them, studies on prevention of oral diseases by studying various components such as green tea extract and sodium fluorophosphates.

Recently, the antimicrobial effect of periodontal disease on bacterial growth was investigated in order to investigate whether catechin component of green tea could be used to improve periodontal disease by Hirasawa et al. [16].

As a result, it was reported that the minimum inhibitory concentration was 1 mg/ml in Porphyromonas gingivalis and Prevotella species. Catechin components are present in oolong tea, black tea, and black tea as well as green tea, and they are mostly used for cavity prevention in the dental field [17]. White reported that the remineralization effect was 32% in dentifrice containing sodium fluoride and 35% in dentifrice containing sodium fluoride and sodium fluoride, and 64% in dentifrice containing sodium fluoride [18].

In 1942, Dean et al. [19] reported that the addition of fluoride to drinking water improves the effectiveness of dental caries prevention. The first study of toothpaste using sodium monofluoroacetate was performed by Finn and Jamison [20] in 1963. Sarin et al. [21] confirmed plaque and gingivitis reduction in mouthwash containing 2% green tea.

Bae et al. [22] confirmed that gingivitis was reduced when toothpaste containing sodium fluoride, cetylpyridinium chloride green tea extract, and pine needle extract were used.

The purpose of this study was to investigate the effect of sodium fluoride and green tea extract on mouthwash of 60 male adults. Before the experiment, all subjects were instructed to use a rotating toothbrush, and after brushing three times a day, mouthwash was used. The study was conducted using the mouthwashes distributed to 30 individuals using experimental mouthwash and 30 individuals using comparative mouthwash for 16 weeks.

PMA index was 9.25 in the experimental group (C) and 9.21 in the control group (E) before the experiment, the experimental group (C) was 6.96 and the control group (E) was 9.07 after 4 weeks, and decreased to 7.46 in the experimental group (C) and 8.79 in the experimental group (C) after 8 weeks, and there was statistically significant decrease of gingivitis after 4 weeks (p<0.05). The experiment was carried out with mouthwash containing sodium fluorophosphate.

Gingival index was 2.00 in the experimental group (C) and 2.01 in the control group (E) before the experiment, the experimental group (C) was 1.80 and the control group (E) was 1.95 after 4 weeks, and decreased to 1.82 in the experimental group (C) and 1.97 in the experimental group (C) after 8 weeks. After 4 weeks and 8 weeks, the experimental group (C) was statistically significantly lower than the control group (E) (p<0.05).

Therefore, the authors hypothesized that sodium fluorophosphate and green tea extract are effective in reducing gingivitis, and were able to confirm the effectiveness of mouthwash in reducing gingivitis after 4 weeks.

Mouthwash will make up for the shortage. It is believed that it will help reduce inflammation of the gingiva and maintain a healthy periodontal state stably.

In conclusion, the authors studied gingivitis reduction effect of mouthwash containing sodium fluorophosphate and green tea extract. Similar studies and other studies can play an important role as important information and resources in the future. Long-term clinical studies under various conditions are required to evaluate whether or not to contribute to future oral health. In the future, it will be necessary to develop customized mouthwash formulated as an ingredient useful for oral disease prevention.

Sixty subjects were selected from 30 subjects in the experimental group and 30 subjects in the control group in order to investigate the effect of gingiva and periodontal changes in mouthwash containing sodium fluoride and green tea extracts. The mouthwash was used for 8 weeks in total. PMA index and gingival index were measured 6 times before, 3 day, 5 day, 4 weeks, 8 weeks, and 16 weeks after the experiment and the following conclusions were obtained.

1. PMA index was 9.25 in the experimental group (C) and 9.21 in the control group (E) before the experiment, the experimental group (C) was 6.96 and the control group (E) was 9.07 after 4 weeks, and decreased to 7.46 in the experimental group (C) and 8.79 in the experimental group (C) after 8 weeks, and there was statistically significant decrease of gingivitis after 4 weeks (p<0.05).

2. PMA index was statistically significant after 4 and 8 weeks in the experimental group (p<0.05). In the experi-mental group, it was confirmed that PMA index decreased significantly from the 4th week after the experiment.

3. Gingival index was 2.00 in the experimental group (C) and 2.01 in the control group (E) before the experiment, the experimental group (C) was 1.80 and the control group (E) was 1.95 after 4 weeks, and decreased to 1.82 in the experimental group (C) and 1.97 in the experimental group (C) after 8 weeks. After 4 weeks and 8 weeks, the experimental group (C) was statistically significantly lower than the control group (E).

Gingival index of Talbott, Mandel and Chilton was 2.00 in the experimental group (C) and 2.01 in the control group (E) before the experiment, the experimental group (C) was 1.80 and the control group (E) was 1.95 after 4 weeks, and decreased to 1.82 in the experimental group (C) and 1.97 in the experimental group (C) after 8 weeks. After 4 weeks and 8 weeks, the experi-mental group (C) was statistically significantly lower than the control group (E) (p<0.05).

4. Talbott, Mandel and Chilton found that there was a statistically significant difference in the experimental group after 4 weeks and after 8 weeks (p<0.05), and in the experimental group, significant gingival index reduction was observed from 4 weeks after the experiment to before the experiment (p<0.05).

As a result, it was shown that gingivitis was reduced when sodium fluorophosphate and green tea extract-containing mouthwash were used in this study. Therefore, it seems to be effective for use in periodontal disease patients.

No potential conflict of interest relevant to this article was reported.