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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age9-13
SponsorCairo University

About this trial

The study aim to to assess the antiplaque and antigingivitis efficacy of Triphala mouthwash versus chlorhexidine mouthwash among children.

Oral health, acknowledged as equally significant to general health, has become an essential component of an individual's entire well-being. Dental caries and periodontal problems are the two predominant oral conditions that repeatedly affect nearly all individuals throughout their entire lives (Sharma et al., 2014).

Numerous bacterial communities can be found in the oral cavity. These bacteria are harmless if proper health is maintained and are a healthy part of the human microbiome; However, disturbances to the local or systemic environment can lead to opportunistic infections such as periodontitis, gingivitis, or cavities .

It has been known that dental plaque plays a critical role in the development and progression of periodontal disease, gingivitis, and dental caries. Plaque control is the first line of defense against periodontal disease and gingival inflammation, and chemical plaque control methods should always be used in conjunction with mechanical methods .

Plaque removal is constantly maintained by mechanical techniques like toothbrushing and flossing, which are essential for controlling and preventing gingivitis, periodontitis, and dental caries. For mechanical plaque control, children need chemotherapeutic agents like therapeutic mouthwash since they lack the motivation or hand-eye coordination to reach the interproximal locations on their own.

Herbal medicine takes a preventative and promotional strategy. It is an integrated approach that treats diseases and promotes health by using a variety of treatments made from plants and their extracts. The use of natural herbs such as Triphala, Tulsi Patra, Jyestiamadh, Neem, Clove Oil, Pudina, Ajwain, and many more, either alone or in combination, has been shown by research to be a safe and effective treatment for a variety of oral health issues, including mouth ulcers, bleeding gums, halitosis, and tooth decay prevention .

Triphala, which exhibits antibacterial, antiseptic, and anti-inflammatory effects, is one of the most popular formulas in traditional Ayurvedic medicine. It is extensively used in dentistry and includes equal amounts of Terminalia Chebula, Terminalia Belerica, and Emblica Officinalis .

Triphala comprises tannins that facilitate the physical removal of microorganisms by aggregating them. This reduces the quantity of bacteria adhering to teeth during the initial phases of plaque development. Triphala mouth rinse exhibits extensive antibacterial activity against both Gram-positive and Gram-negative pathogens. It also demonstrates antioxidant properties that aid in minimizing dental plaque and gingivitis. The tannic acid in Triphala may facilitate plaque reduction by binding to bacterial cell surfaces that denature proteins and eradicate bacterial cells.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 9 to 13 years.

Apparently in good general health.

Both sexes.

Informed consent from their parents.

Disqualifiers

Patients with known allergies to any ingredient used in the study.

History of immunosuppressive diseases.

History of antibiotic or anti-inflammatory therapy in the previous month till the start of the study.

Patients with orthodontic appliances.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.12% Chlorhexidine Mouthwash ( Hexitol )

    Drug

    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.

  • Triphila mouthwash

    Drug

    The participant 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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: use 0.12% Chlorhexidine mouthwash to asses its anti-plaque and anti-gingivitis effectPlacebo comparator 1 intervention
Group B: use Triphala mouthwash to asses its anti-plaque and anti-gingivitis effectExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The amount of plaque accumulation by using 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 tooth surfaces

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.

Time frame
From intervention till 3 weeks

Secondary outcomes

1

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.

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

Time frame
From intervention till 3 weeks

Other outcomes

Sponsors and contacts

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