INTRODUCTION:

The two most common dental diseases, dental caries and periodontal diseases are caused by dental plaque which is complex microbial community. Thus, plaque control should be an indispensable part of the daily tasks of every individual as the onset of dental diseases can be primarily prevented by regular and meticulous plaque removal.¹

The most common form of plaque induced gingival disease is gingivitis, which causes inflammation and bleeding of gingiva.

Dental plaque control can be attained both mechanically and chemically, either alone or in a combination of these two actions. However mechanical plaque control methods have certain innate limitations.

Chlorhexidine digluconate (CHX) is a chemical anti septic solution against gram positive and negative bacteria. It has been the agent of choice when compared to others and is considered as a gold standard.^2,3 However prolonged use of chx mouth washes has been found to be associated with unwanted effects like teeth staining, altered taste sensations,parotitis and mucous membrane irritation.^4,5

To overcome these adverse effects a need for anti-plaque agent with minimal side effects which can be used as an effective adjunct to mechanical plaque control.

Hence, there is a need to come up with an alternative strategy would be the antimicrobial properties of herbal plants. The uniqueness of using plant extracts has been incorporated in dentistry, particularly for treating and preventing gingivitis and dental caries.

Herbal medicine is both promotive and protective in its approach. The major strength of these natural herbs is that their use has not been reported with any side effects till date.

These plant products have been scientifically proven to be safe effective against various oral health problems such as halitosis, mouth ulcers, gingivitis and in dental caries.

The herbal plants which are widely used in field of dentistry as alternative to mechanical plaque control are mint leaves, Neem, curcumin, aloe vera, triphala, tulsi, clove, pomegranate and ajwain and many more.^6,7

Triphala and tulsi is the most common herbal formulations used effectively in dentistry.

Triphala has been described as one of the most effective Ayurvedic herbal formulations consists of Terminalia bellirica Roxb (Bibhitaki), Terminalia chebula Retz (Haritaki), and Emblica Officinalis Gaertn (Amalaki). T. bellirica Roxb and T. chebula Retz have a warm energy, while Emblica Officinalis possess a cooling energy. Triphala has equal parts of these three herbs, which has a balanced internal cleansing and detoxifying formula.

Also has a property of therapeutic agent with balancing, laxative, hemostatic, anti-inflammatory, analgesic and wound healing properties as described in sushrutasamhita. Triphala is having an anti plaque efficacy which is similar to CHX. Triphala also inhibits plaque formation with inconsequential or no side effects .^8,9

Tulsi or the Indian Holy basil belongs to the family of Labiatae and as a botanical name as ocimum sanctum, is one such herb that is conferred with enormous antimicrobial activity and is used to treat a array of illnesses such as diabetes mellitus, arthritis, bronchitis, skin diseases, and dental caries. In addition, compared to other herbal medicines, Tulsi is abundantly available, easily accessible, economically feasible, culturally acceptable, and may have minimal side effects and hence can be recommended for long term use.^10,11

To date and to best of our knowledge, no study has been undertaken to evaluate the clinical efficacy of triphala, tulsi compared with commercially available Chlorhexidine mouthwash.

The aim of this clinical study is to evaluate the efficacy of herbal mouthwash containing triphala and tulsi extracts on reduction of plaque and gingivitis.

MATERIALS AND METHODS:

The study was designed and conducted in theDepartment of Periodontics, SRM Kattankulathur Dental College and Hospital, Potheri, Tamilnadu, from December 2020 to March 2021. Approval from the Institutional Ethics Committee was (IEC/6/2020) obtained before initiating the study. 60 participants, who diagnosed as mild to moderate gingivitis, were enrolled in this randomized controlled double blinded study.

Participants who were allergic to the active ingredients in any of the mouthwashes were excluded from the study. Furthermore, participants who habitually use tobacco, pregnant or lactating mothers, and participants with orthodontic appliances, other oral lesions and participants on any antibiotics in the past 3 months were also excluded from the study.

60 individuals who met inclusion criteria (20 to 45years with mild to moderate gingivitis with a minimum number of 20 teeth and patients who have not undergone periodontal treatment in past 6 months.) were randomly assigned to one of three groups.

Following the selection of patients, they were informed orally about the study after which a written consent was obtained.

Treatment protocol:

60 participants who met inclusion criteria and were randomly assigned into three groups

Group 1:

20 subjects were given 6% Triphala mouth wash

Group 2:

20 subjects were given 6% Occimum sanctum mouth wash

Group 3:

20 subjects were given 0.2% Chlorhexidine mouth wash.

Clinical examinations:

Oral hygiene index-simplified (OHI-S) (Green and Vermilion 1964)¹², Turesky modification of the Quigley–Hein plaque index. (1962)¹³, gingival index (GI) (Loe and Silness 1963)¹⁴ and Bleeding on probing (BOP)¹⁴ were recorded at baseline, 15th and 30th day for all three groups regarding oral hygiene and gingival status.

Method of preparation of triphala mouth rinse:

Triphala was available in a finely sieved powder form called churna (Triphala powder, Carmen organics, Madhya Pradesh). In the present study, 6% Triphala mouthwash was prepared. Sixty grams of pure Triphalachurna was dissolved in 1 L of distilled water to obtain 6% of extract.

For better patient acceptance, 2 ml of sweetening agent (glycerin) and 1ml of flavoring agent (mint oil) were added to the solution.

Method of preparation of Ocimum sanctum mouth rinse:

The test material was prepared with the help of commercially available fine powder of sun dried Tulsi leaves (Tulsi powder, global space health care pvt ltd, Mumbai.) and the powder was dissolved with 100% ethanol. The mixture was filtered with the help of Whatman filter paper and the filtrate was reduced at low temperature (less than 50⁰ C) to obtain a solid residue of Tulsi.

The extract was suspended in polyethylene glycol 400 (20% v/v) and sterile distilled water to give a final concentration of 6% (w/v). As flavoring agent 0.005% spearmint oil was added.¹⁵

The test solutions was stored in brown tinted bottles labelled with respective groups numbers.

Commensally available Chlorhexidine mouthwash (Hexidine, ICPA health products ltd, Mumbai, India) was used as a positive control in the study.

Aqueous preparations of Triphala and Tulsi mouth rinses were prepared in Department of Biochemistry, SRM Institute of Science and Technology, Potheri, Tamilnadu, India.

The selected 60 subjects were randomly distributed into three groups by a lottery method. Following the baseline examination, the participants in three groups were provided with either of the mouth rinse by an assistant, who was not the part of the study. The control group was provided with the Chlorhexidine mouthwash and other study groups were provided with Triphala mouth wash and Tulsi mouthwash.

The mouth rinses were provided in tinted bottles to Group 1: Triphala mouthwash, Group 2: Tulsi mouthwash and Group 3: Chlorhexidine mouthwash, which was coded by the assistant.The investigator was blinded for the mouthwash that was being given to the patients. The patients were also initially blinded at the time of allocation of the mouth rinses to them.

Data were collected at baseline, 15^th day and 30^th day, all indices were recorded and tabulated. After recording of the clinical parameters at baseline all the individuals received scaling and polishing to remove calculus, and extrinsic stains. They were advised to use 10 ml of each mouthwash for approximately 30 seconds twice a day following breakfast for a period of 30 days. Patients were advised not to use mouth rinse after brushing.

Statistical analysis:

The data were analyzed using SPSS version 17. Depending upon the nature of data, ANOVA with least significant difference Bonferroni test was used in intergroup comparison and a value of p<0.05 was considered as statistically significant.

RESULTS:

The present study comprised of 60 subjects 20 each in Triphala, Tulsi and Chlorhexidine groups. There were no dropouts in this study and none of the participants reported any adverse effects regarding the use of mouth rinses.

Table 1 represents mean ±SD values of OHI-S, GI, PI, BI and all three groups showed gradual decrease in all parameter values from baseline to follow up visits at 15 and 30 days.Before interventions(baseline) there is no significant difference between the interventional groups with respect to all parameters.

There was a no significant change was detected with respect to GI, PI, BI and OHI-S in all three groups, between baseline, 15^th and 30^th day (Table-1).

When group 2 is compared with group 3, group 3 shows better reduction in parameters which is significant (Table -2).

In groups 2 and 3 there was statistically highly significant reduction in mean gingival scores between baseline,15th day and 30th day (Table-3).

In groups 2 and 3 there was statistically highly significant reduction in mean bleeding scores between baseline,15th day and 30th day (Table-4).

Table 1: OHI-S Index

	Group 1 Triphala	Group 2 Tulsi	Group 3 Chlorhexidine	Anova(F)	P. Value (0.05)
OHI-S baseline	0.9810	0.8820	0.9050	0.75	0.49
OHI-S 15 days	0.7650	0.7520	0.5315	2.15	0.12
OHI-S 30days	0.6180	0.7261	0.2050	13.6	0.07

OHI-S Index:

There was not any significant difference in all 3 groups(P>0.05) at baseline,15 days and at 30 days were tabulated above.

Table 2: Plaque Index

	Group 1	Group 2	Group 3	Anova (F)	P.Value (0.05)
PI baseline	0.8760	0.7710	0.9025	0.62	0.39
PI 15 days	0.6760	0.6410	0.4205	3.75	0.01
PI 30 days	0.6290	0.6060	0.1940	14.4	0.000

Plaque Index:

There was not any significant difference in all 3 groups(P=0.39) at baseline. At 15 days all 3 groups were statistically significant p (0.01). At 30 days, the values of all 3 groups were to be statistically significant(p=0.00)

Table 3: Gingival Index

	Group 1	Group 2	Group 3	Anova (F)	P. Value (0.05)
GI baseline	0.6350	0.5715	0.6475	0.55	0.423
GI 15 days	0.5315	0.4528	0.4075	2.23	0.079
GI 30 days	0.4915	0.2100	0.2080	11.07	0.000

Gingival Index:

At baseline, GI values were not any significant difference between all three groups(p=0.423).

At 15^th day the chlorhexidine group showed reduced values compare to other two groups, but it was not statistically significant (p=0.079). At 30^th day higher and similar reduction was seen in tulsi and chlorhexidine groups were to be statistically significant with triphala (p=0.00).

Table 4: Bleeding Index

	Group 1	Group 2	Group 3	Anova (F)	P. Value (0.05)
BI baseline	0.7150	0.5015	0.6360	2.157	0.12
BI 15 days	0.6154	0.3945	0.3435	6.139	0.002
BI 30 days	0.3220	0.3175	0.3205	19.50	0.00

Bleeding Index:

At baseline, there was no significant difference to be found. At 15^th day in an intergroup comparison, through the chlorhexidine group showed slightly better results than the other groups, the difference was statistically significant p(0.002). At 30^th day in an intergroup comparison, all the three groups exhibited values were be similar but slight reduction seen in tulsi compared to other two groups which is statistically significant (p = 0.00)

DISCUSSION:

The results of this study indicate that the two herbal mouth rinses used in the present study improved oral hygiene with regards to gingival index and gingival bleeding at the end of 30 days but more statistically significant reduction occurred in case of tulsi mouthwash.

In accordance with the study conducted by Gupta et al., gingival bleeding and gingival index showed a significant difference at the end of 30 days in tulsi group. This can be attributed to its antimicrobial, antibacterial and anti-inflammatory properties.¹⁶

Another study reported by Hosadurga et al. using 2% Ocimum sanctum gel in an experimental model showed reduction in gingival inflammation and probing pocket depths. These are comparable with the results obtained in the present study.^17,18

The results with respect to triphalamouthrinse are also in accordance with a study by Bhattacharjee et al. where reduction of plaque and gingivitis among children was noted and concluded that both CHX and triphala groups showed significantly lower gingival and plaque index scores at follow-up than baseline.^19,20

Chlorhexidine was more efficient in improving gingival inflammation. Both tulsi and triphala were found to be helpful in this, but intergroup comparison showed results were not statistically significant. These findings are similar to previous studies.^{21,22,23,24,25.}

CONCLUSION:

In the present study, triphala, tulsi showed equal efficacy to that of chlorhexidine. Our study also demonstrates that Tulsi was effective in controlling gingivitis when compare to triphala. within the limitations of this clinical study these herbal medicines can be used effectively alternative to chlorhexidine mouth wash.

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Received on 18.03.2021 Modified on 24.02.2022

Research J. Pharm. and Tech 2023; 16(5):2137-2141.

DOI: 10.52711/0974-360X.2023.00351