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Clinical Trials in Egypt / NCT07016659
Starting soon Phase 3

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

NCT07016659 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2025-09-01
Last updated
2025-06-12

Condition(s) studied

Plaque AccumulationGingival Inflammation

Investigational drug(s) / intervention(s)

0.12% Chlorhexidine Mouthwash ( Hexitol ) →Triphila mouthwash

0.12% Chlorhexidine Mouthwash ( Hexitol ): 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: 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

Study summary

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

Sex
ALL
Min age
9 Years
Max age
13 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients aged 9 to 13 years. * Apparently in good general health. * Both sexes. * Informed consent from their parents. * Patients with fair oral hygiene and gingival inflammation. * Participants should not have used mouthwashes for the follow-up period. Exclusion Criteria: * 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. * Parents refused to participate or were unable to attend follow-up visits.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry Cairo Universty Cairo Egypt

More Cairo University trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07016659 on ClinicalTrials.gov ↗ ← All trials in Egypt