Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study

doi:10.21203/rs.3.rs-4374624/v1

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Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study

https://doi.org/10.21203/rs.3.rs-4374624/v1

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Background

While professional dental treatments are mandatory for advance periodontitis, maintaining proper oral hygiene can significantly contribute to preventing disease progression. Some herbal toothpastes and natural plant components may have some beneficial properties. Aloe vera is a medicinal plant with active ingredients that show antioxidant and anti-inflammatory effects. A toothpaste containing salt and Aloe vera may have adjunctive influence to non-surgical periodontal treatment.

Aim

This randomized parallel-group comparison study aimed to investigate the efficacy of an Aloe vera toothpaste (test group) compared to a Sodium bicarbonate toothpaste (control group) and a base toothpaste (benchmark group), with respect to outcomes of periodontitis treatment.

Methods

Fifty-four periodontitis patients were arbitrarily allotted into three groups. All subjects received mechanical instrumentation and instruction on oral hygiene using a toothbrush with these toothpastes and dental floss for a whole period of the study. The participants were evaluated at baseline (T0), week 4 (T1), and week 12 (T2) after complete full mouth scaling and root planing. During the visits, plaque score (PS), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL) were assessed and analyzed.

Results

The comparison groups had similar mean PS and BOP at baseline. At T1 and T2, both scores were reduced, however there was no statistically significant difference among the three groups for PS. A significant reduction in BOP score among the groups was observed (p < 0.01) at T1. The PD in all groups were reduced significantly after non-surgical periodontal treatment. The CAL reduction was superior in the test group compared to the benchmark and the control group. In addition, there was no significant difference in the mean CAL among time points in the both benchmark and control groups.

Conclusions

Aloe vera toothpaste significantly decreased gingival bleeding, probing depth, and clinical attachment level in periodontitis patients during active periodontal treatment.

Aloe vera

Herbal product

Toothpaste

Periodontitis

Periodontal treatment

Periodontitis is a multi-factorial disease which affects a major part of world population. Key periodontal pathogens in supra- and subgingival dental biofilm and periodontal tissues interact with host immune response via innate and adaptive immunity. This results in destruction of connective tissue and alveolar bone and might end to tooth loss. [1, 2] To arrest progressive attachment loss, both systemic and local risk factors associated with periodontitis have to be controlled. The removal of dental plaque and deposits by scaling and root planing (SRP) during the active periodontal treatment is imperative. [3] Additionally, the importance of oral hygiene care in the strict supportive periodontal treatment showed long-term stable periodontal status. [4, 5]

Routine mechanical tooth cleaning by toothbrushing alongside toothpaste is an effective method to reduce the pathogenic microbial load. To achieve this goal, toothpaste containing antibacterial and chemical agents, i.e. chlorhexidine, triclosan, metal salts, have been tested. [6] Presently, the awareness of the minimal toxicity and less harmful effects of herbal toothpastes has enlarged. Aloe vera (A. vera) is a medicinal plant that is commonly used to treat acute or chronic wounds. It is non-toxic substance and could significantly intensify fibroblast cell migration. [7] Additionally, the polysaccharides in A. vera gel lessened the bacterial load by promoting phagocytosis to eradicate the microbes. [8] A toothpaste containing A. vera demonstrated antimicrobial property on oral microorganisms, such as Streptococcus mutans and Candida albicans. [9, 10] Moreover, a significant reduction in plaque accumulation from a mouth rinse containing A. vera was also observed. [11] The A. vera extract treatment has also resulted in a significant reduction of glutathione, superoxide dismutase, catalase, glutathione peroxidase, and glutathione S-transferase in the liver and kidney of diabetic rats, showing the antioxidant property of A. vera gel extract. [12] Recently, the herbal toothpaste containing A. vera and other herbal products used in the study was analyzed in laboratory experiment. It significantly increased gingival fibroblast cell migration and showed greater Porphyromonas gingivalis biofilm inhibition. [13] The toothpaste with antibacterial and enhancing healing properties could be alternative option for oral care that might foster oral health benefits during periodontal disease treatment.

The objective of the study was to evaluate the effect of an herbal toothpaste during active periodontal treatment in untreated periodontitis patients.

Study design and population

The protocol for the human experiment was approved by the Ethical Committee of the Research Institute of Rangsit University (Project number RSUERB2020-011). This study protocol was approved by Thai Clinical Trials Registry on 16/5/2024 https://www.thaiclinicaltrials.org/show/TCTR20240516001 (the Clinical trial registration number TCTR20240516001). The study was carried out at the College of Dental Medicine, Rangsit University, Pathumthani, Thailand. The subjects were required to have at least 4 permanent teeth with periodontal pocket depth greater than 4 mm along with radiographic alveolar bone destruction. Besides, the subjects had to (1) have full mouth plaque score > 40%; (2) exhibit bleeding on probing > 30%; (3) be in the age range of 20–70 years; (4) provide informed consent. Exclusion criteria were the participants who had (1) been diagnosed as dental plaque induced gingivitis or non-plaque induced gingival lesions; (2) nonsurgical periodontal treatment in the preceding 12 months; (3) orthodontic treatment within 12 weeks; (4) periodontal surgery in the preceding 12 weeks; (5) ongoing treatment with antimicrobials and/or anti-inflammatory medication; (6) been pregnancy or lactation; (7) been smoking or alcohol abuse; (8) a history of an allergic reaction to the toothpastes. The informed consent was obtained from all subjects and/or their legal guardian(s).

Intervention

The study was a double-blinded randomized parallel-group comparison between the following three toothpastes: (1) herbal toothpaste containing the following active ingredients: A. vera, sodium chloride, mangosteen peel, whole Hydrocotyle plant, Clinacanthus nutans, extracts of orange jessamine leaf and toothbrush tree as displayed in Table 1 (Twin Lotus Co., Ltd, Bangkok, Thailand) (test group) (2) Sodium bicarbonate toothpaste (Parodontax®, Glaxo-SmithKline (Thailand), Ltd, Bangkok, Thailand) (control group) (3) Base toothpaste containing sorbitol, glycerin, calcium carbonate, and sodium lauryl sulfide (benchmark group).

Table 1

Full scientific species of active ingredients in herbal toothpaste
Active ingredient	Full scientific species
Aloe vera	Aloe vera (L.) Burm. f.
Clinacanthus nutans	Clinacanthus nutans (Burm.f.) Lindau.
Orange Jessamine leaf	Murraya Exotica L.
Hydrocotyle	Centella asiatica (L.) Urb.
Toothbrush tree	Streblus asper Lour.
Mangosteen peel	Garcinia mangostana Linn.

The subjects were arbitrarily allotted into one of three groups with the technique of simple randomization. All subjects received a nonsurgical periodontal treatment and oral hygiene instruction by using a soft-bristle toothbrush (Colgate®) with one of the aforementioned toothpastes at least 4 minutes and dental floss (Colgate®) twice daily for an entire period of study. All participants were evaluated at baseline (before the treatment); T0, 4 weeks after complete full mouth SRP; T1, and 12 weeks after SRP (end of the follow-up); T2. At the baseline and follow-up examinations, the following parameters were studied;

Plaque score (PS):

All teeth were stained with an erythrosine dye disclosing agent. The presence or absence of continuous biofilm at the cervical 1/3 of the facial, lingual, and proximal surfaces of each tooth was determined. The percentage of tooth surfaces with dental biofilm was calculated in each participant. [4]

Bleeding on probing (BOP):

The presence or absence of bleeding in six gingival units around each tooth (mesio-facial, midfacial, disto-facial, disto-lingual, midlingual, and mesio-lingual) was assessed following probing. The percentage of inflamed gingival units in relation to the total number of gingival units present was determined.

Probing depth (PD) and Clinical attachment level (CAL):

The Williams probe was used to measure PD (the distance from the gingival margin to the apical portion of the gingival sulcus) (mm) and CAL (the distance from cementoenamel junction to the apical portion of the gingival sulcus) (mm) in six units around each tooth. The means of full mouth PD and CAL were calculated.

Statistical analysis

The Kruskal–Wallis test was used to compare the means after using different toothpaste among the three comparison groups. The Bonferroni correction for multiple test was utilized to determine the differences between the means within the group at different visits for PS and BOP. The Friedman test was carried out to determine the differences between the means within the group at different visits for PD and CAL. The significance level was set at p < 0.05. Data analysis was achieved using Statistical Package for the Social Sciences version 18.0 for Windows (SPSS, Inc., Chicago, IL).

A total of 54 qualified subjects agreed to join and were thus randomized (22 in the test group; 13 in the control group; 19 in the benchmark group). The age range of participants was 34–70 years, and the majority were male (63%). There was no report of adverse side effect or allergic reaction from using all toothpastes. The mean of full mouth PS, BOP, PD, and CAL at different time point are shown in Tables 2 and 3 which were not different across the groups at baseline.

The comparison groups had similar mean PS and BOP at baseline (p > 0.05). At week 4 and 12, both scores were reduced. There was no statistically significant difference among the three groups for PS. However, there was a significant reduction in BOP score (p < 0.01) at week 4. The control group showed lowest mean full mouth BOP (13.83%) compared to test and benchmark group; 17.52% and 21.03% respectively. Moreover, there was no a statistically significant difference in BOP among the groups at the end of the study (p > 0.05). (Table 2).

The means of PD and CAL among the three comparison groups are shown in Table 3. There was no overall difference of PD and CAL among groups at the beginning of the study. The PD in all groups were reduced significantly after nonsurgical periodontal treatment. In the test group, the PD decreased from 3.10 mm at baseline to 2.67 mm in week 4 and then to 2.63 mm in week 12. The reduction pattern was similar to that of the control group, in which the PD decreased from 3.02 mm at baseline to 2.44 mm in week 4 and 2.52 mm at the end of the study. At week 4 and week 12, there also was a statistically significant PD reduction for the benchmark group (p ≤ 0.001). The changes in CAL in all groups at different time point are shown in Table 3. The CAL were similar among the groups at baseline. Only the test group, the mean CAL significantly diminished from 2.71 mm at baseline to 2.30 mm at week 4 and 2.43 mm at week 12 (p < 0.05). A reduction was also observed in the benchmark and control group, in contrast, this change was not statistically significance, from 2.63 and 2.71 mm to 2.34 and 2.62 mm respectively at the end of study. The Kruskal–Wallis test revealed that CAL reduction was superior in the test group compared to the benchmark and control group. In addition, there was no difference in the mean CAL between time point in the both benchmark and control groups.

Periodontitis is a highly prevalent disease and prevention of occurrence or recurrence is dependent on patient’s plaque control. The ultimate goal of periodontitis treatment is to arrest progressive attachment loss, reduce pocket depths and control both systemic and local risk factors associated with periodontal diseases. Mechanical tooth cleaning is mainly influenced by the amenability and dexterity of the individuals and by the design features of oral hygiene aids. The maintenance of an effective level of plaque control is clearly difficult using conventional mechanical procedure and toothpaste and yet, from a therapeutic point-of-view. We assessed whether herbal toothpaste improved clinical gingival inflammation and periodontal parameters. The present study mainly focused on the effect of an herbal toothpaste during phase 1 periodontal treatment. We found that the herbal toothpaste containing A. vera reduced gingival inflammation, PD, and CAL in untreated periodontitis patients.

The recent systematic review showed that the herbal toothpaste had superior effect over non-herbal toothpaste in dental biofilm reduction during a short term. [14]. On the contrary, our study did not show the difference of plaque reduction among the three groups after short and long term observations. The significant plaque reduction among groups might be strongly influenced by the individualized oral hygiene instruction which was chairside demonstrated by the operator. Interestingly, there was an overall substantial significant difference in gingival inflammation reduction at week 4 among the study groups. However, at the end of follow up, there was no a statistically significant difference in BOP among the groups even though the test group showed lowest mean full mouth BOP (17.85%) compared to the control and the benchmark group. The longer follow-up time may be required to evaluate long term outcomes. This is consistent with the preexisting literature which claimed that the herbal toothpaste did not reduce gingival inflammation for both short-term (4-week follow-up) and long-term (12-week follow-up) effects when compared to non-herbal toothpaste [14]. Additionally, there are some literatures which the results presented that the A. vera toothpaste was able to essentially reduce gingival index in the treatment of gingivitis. No side effects were observed due to the use of this herbal toothpaste. [10, 15]

Another result of the present study is that the PD in all groups were reduced significantly in the same pattern after scaling and root planing. Then probing depth reduction in the test and control groups did not show a difference compared to that in the benchmark group. Interestingly, the mean CAL in the test group diminished from 2.71 mm to 2.43 mm at week 12. A reduction was also observed in the benchmark and control group, however, this change was not statistically significance. The CAL reduction efficacy at the end of the study was utmost in the test group compared to the benchmark and control group.

For the past two decades, herbal-related research has remarkable affected to oral health care especially oral lesion, periodontal and peri-implant disease treatment. Local delivered application predominates in dental industry, such as toothpastes, mouth rinses, varnishes, and gels have been the most commonly examined in numerous pharmaceutical forms [16, 17]. Most of the herbal toothpastes show antiplaque and anti-inflammatory effects. [18, 19, 20] There are a limited number of studies regarding the efficacy of the herbal toothpaste as an adjunctive to periodontal treatment. To the best of our knowledge, this is the first study to assess the efficacy of A. vera toothpaste as an adjunctive method in periodontitis treatment. The herbal toothpaste containing A. vera that was used in the present study has been studied in vitro recently. This formulation significantly increased human gingival fibroblast cell migration which could have a positive effect to periodontal wound healing and regeneration. Furthermore, it demonstrated greater Porphyromonas gingivalis biofilm inhibition compared with the 0.12% chlorhexidine digluconate solution group. [13]

The results in this study indicate that the use of the herbal toothpaste revealed superior efficiency compared with regular toothpastes in treating periodontitis. A toothpaste which could enhance wound healing is an alternative option for oral care that would provide oral health benefits for non-surgical periodontal treatment. However, the long-term effect of the A. Vera toothpaste should also be investigated. Another study limitation is the sample size. Since the data in each group were not normally distributed, further research should employ both greater sample size and a lengthier follow-up period.

This study documented that A. vera toothpaste significantly decreased gingival inflammation, PD, and CAL in periodontitis patients during non-surgical treatment.

A.vera: Aloe vera; PS: Plaque score; BOP: Bleeding on probing; PD: Probing depth; CAL: Clinical attachment level; SRP: Scaling and root planing

Acknowledgements

Not applicable.

Author’s contributions

LV and PS conducted the entire study. PS was the corresponding author. SB, KS, and VD were responsible for data collection. SK was responsible for data analysis. All authors had read and approved the final manuscript.

Funding

This research was funded by the National Science and Technology Development Agency under the Ministry of Science and Technology, Thailand.

Availability of data and materials

All data generated or analyzed during this study were included in this article.

Ethics approval and consent to participate

The protocol for the human experiment was approved by the Ethical Committee of the Research Institute of Rangsit University. The informed consent was obtained from all subjects and/or their legal guardian(s).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Author details

¹ College of Dental Medicine, Rangsit University, Pathumthani 12000, Thailand

² Research Office, Faculty of Dentistry, Mahidol University, Bangkok 10400, Thailand

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Table 2 and 3 are available in the Supplementary Files section.

No competing interests reported.

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Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study

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Version 1

Abstract

Background

Aim

Methods

Results

Conclusions

Background

Materials and methods

Statistical analysis

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Table 2 and 3

Additional Declarations

Supplementary Files

Status:

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