Triphila Mouthwash Effect as Anti-plaque and Anti-gingivitis in Children

The oral cavity possesses many kinds of bacterial communities. In a healthy condition, these bacteria are benign and represent a component of the human microbiome; however, changes in local or systemic environments can lead to opportunistic infections such as caries, gingivitis, or periodontitis (Vlam, 2019).

Gingivitis develops after 2 to 3 weeks of uninterrupted plaque accumulation, accompanied by a transition in subgingival bacteria from gram-positive to gram-negative species. Plaque-induced gingivitis, the most common form of periodontal disease, has been demonstrated by epidemiological studies to be frequent among dentate populations of all ages (Murakami et al., 2018; Deus and Ouanounou, 2022). In children aged 6 to 11, gingivitis was present in almost 73% of cases in developed nations. Besides, 50 - 99% of people develop gingivitis throughout adolescence (Pari et al., 2014).

Chlorhexidine (CHX) has established a reputation as the gold standard in chemical plaque reduction; however, long-term usage of CHX may result in a variety of problems, including dry mouth, changed taste perception, metallic taste, and tooth discoloration. Despite its anti-plaque capabilities, 0.12% CHX mouthwash has been associated with increased calculus deposition (Zanatta et al., 2010; Dandekar and Winnier, 2020). Thus, the quest for an ideal mouthwash with the beneficial properties of CHX without its side effects continues.

Triphala is one of the most popular formulations in ancient Ayurvedic medicine because it possesses antibacterial, antiseptic, and anti-inflammatory properties. It contains equal quantities of Terminalia Chebula, Terminalia Belerica, and Emblica Officinalis; it is commonly used in dentistry. Triphala was chemically examined and was discovered to have tannic acid, chebulic acid, and flavonoids as major ingredients (Minervini et al., 2024; Singaraju et al., 2024).

Triphala includes tannins, which assist in physically eliminating microorganisms by aggregating them together. This reduces the quantity of germs that attach to teeth during the initial stages of plaque development. Triphala mouth rinse has wide antibacterial properties against both Gram-positive and Gram-negative pathogens. It also has antioxidant properties that aid in reducing dental plaque and gingivitis (Minervini et al., 2024; Singaraju et al., 2024).

Numerous research studies have been done on the beneficial effects of Triphala mouthwashes on the management of plaque and gingivitis in adults. A knowledge gap persists regarding the effectiveness of Triphala mouthwash as an anti-plaque and anti-gingivitis among children and adolescents (Minervini et al., 2024).

Benefits of the study to participants:

* Provide a natural, effective herbal Mouthwash that provides antiplaque and anti-gingivitis properties. * Minimal side effects. * It will be cost-effective for the patient.

Benefits of the study to the community:

* Introducing a new mouthwash with minimal side effects. * Improving the standards of pediatric dental care. * Enhance the overall health of participants.

Benefits of the study for clinicians:

* Providing a new and alternative treatment option. * Providing treatment with minimal side effects. * Can be prescribed for a longer duration without fear of side effects. Explanation regarding the choice of comparators Chlorhexidine has been recommended as the gold standard for the treatment of gingivitis owing to its high success rate in the management of plaque accumulation and gingivitis when compared to other mouthwashes due to its antimicrobial and anti-inflammatory properties (Sharma et al., 2014).

Study Setting and Location

* Source of patients: This study will be conducted in the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt. * Operator: The Principal Investigator. * Dental units: Knight Midmark Biltmore dental unit (Midmark Corporation 1700 S. Patterson Blvd., Suite 400, Dayton, Ohio 45409, USA). * Instruments: Dental light, Mouth mirror \& Periodontal probe.

The principal investigator will perform all clinical procedures as follows:

* Preoperative diagnostic procedures:

1. Diagnostic charts with personal, medical, and dental history will be taken and recorded in the patient's diagnostic chart 2. A clinical examination will be performed using a sterile mirror and probe to assess the eligibility criteria. 3. if the patient fulfills the inclusion criteria, written informed consent will be obtained from the parents or the legal guardians, and verbal assent from the participant 4. Preoperative and postoperative photographs will be taken. 5. Baseline data, including both the gingival and plaque index, will be recorded in the patient diagnostic chart . 6. Participants will be given meticulous oral hygiene instructions and appropriate brushing techniques. 7. Patients will be allocated to the interventional or control groups with an allocation ratio 1: 1. Group I (Interventional group): Triphala mouthwash. Group II (Control group): Chlorhexidine mouthwash.

For the interventional group (Triphala mouthwash):

Participants will be supplied with 100 ml of prepared 6% Triphala mouthwash. They will be instructed to administer 15 ml of the mouthwash and swish it for 30 seconds two times daily under the supervision of their parents, 30 to 45 minutes after toothbrushing for 2 weeks. They will be instructed not to rinse or eat anything for 30 minutes after mouthwash use.

Method of preparation of Triphala mouthwash:

Triphala is available in a finely sieved powder form where a 6% Triphala mouthwash will be prepared according to (Bhattacharjee et al., 2015; Pradeep et al., 2016). Sixty grams (60 g) of pure Triphala powder will be dissolved in one liter of distilled water to obtain 6% of the extract. To improve patient compliance, two ml of glycerin will be added as a sweetening agent, and one ml of Pudin Hara will be added as a flavoring agent. The solution will be brought to boil for 10 minutes, then cooled and filtered. This mouthwash will be placed in opaque, sterile, sealed bottles.

For the Control group (Chlorhexidine mouthwash):

Participants will be supplied with 100 ml of commercially available 0.12% chlorhexidine mouthwash. About 10 ml will be administered, and participants will be asked to swish mouthwash for 30 seconds two times daily under the supervision of their parents, 30 to 45 minutes after toothbrushing for 2 weeks. They will be instructed not to rinse or eat anything for 30 minutes after mouthwash use.

The strategies used to improve adherence to the intervention:

The participants will be given a brushing calendar to mark every time they use mouthwash and bring this time at follow-up visits.

Follow-up visits:

The participants will be recalled after one week, two weeks, and three weeks.

For outcome assessment:

Training the examiners to conduct the clinical trial by the supervisors before the study initiation. The sessions will be conducted over two days. The first day will be an alignment session where the research team will review the clinical parameters in detail. The second day will be the assessment session when the principal investigator asses the patients with the characteristics of the study and the supervisors will evaluate the reliability of the examiner assessment.

Primary outcome Plaque index :

The Plaque index will be recorded using the mirror, periodontal probe, and disclosing agent to detect areas of plaque accumulation that will be stained by the disclosing agent at four areas for each tooth, including buccal, lingual, mesial, and distal.

Criteria of plaque index:

0 = No plaque. 1. = Film of plaque adhering to the free gingival margin and adjacent area of the tooth. 2. = Moderate accumulation of plaque within the gingival pocket. 3. = An Abundance amount of plaque within the gingival pocket.

To obtain the plaque index score for each tooth:

The sum of the four tooth surface scores will be divided by four.

Secondary outcome Gingival index:

The gingival index will be recorded using a mirror and periodontal probe to assess the gingival status in four areas for each tooth, including buccal, lingual, mesial, and distal.

Criteria of the gingival index:

0 = Normal gingiva, no bleeding on probing \& no inflammation. 1. = Slight change in color \& slight edema of the gingiva, mild inflammation, and no bleeding on probing. 2. = Redness, edema, and glazing of the gingiva, moderate inflammation, and bleeding on probing. 3. =Marked redness, edema, ulceration of the gingiva, severe inflammation, and spontaneous bleeding.

To obtain the gingival index score for each tooth:

• Gingival health by using Gingival Index The gingival index will be recorded using a mirror and periodontal probe to assess the gingival status in four areas for each tooth including buccal, lingual, mesial, and distal. [Time frame: From intervention till 3 weeks]