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

NCT07016659 | Not Yet Recruiting Phase 3

• 1 other identifier: Triphila as antiplaque
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Accumulation; Gingival Inflammation

Keywords

triphila mouthwash; anti-plaque; anti-gingivitis; children

Outcome Measures

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.

  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.

  From intervention till 3 weeks

Study Arms (2)

use 0.12% Chlorhexidine mouthwash to asses its anti-plaque and anti-gingivitis effect

PLACEBO COMPARATOR

Drug: 0.12% Chlorhexidine Mouthwash ( Hexitol )

use Triphala mouthwash to asses its anti-plaque and anti-gingivitis effect

EXPERIMENTAL

Drug: Triphila mouthwash

Interventions

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.

use 0.12% Chlorhexidine mouthwash to asses its anti-plaque and anti-gingivitis effect

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

use Triphala mouthwash to asses its anti-plaque and anti-gingivitis effect

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo Universty

Cairo, Egypt

Location

Related Publications (17)

• Zanatta FB, Antoniazzi RP, Rosing CK. Staining and calculus formation after 0.12% chlorhexidine rinses in plaque-free and plaque covered surfaces: a randomized trial. J Appl Oral Sci. 2010 Sep-Oct;18(5):515-21. doi: 10.1590/s1678-77572010000500015.

  PMID: 21085810 BACKGROUND

• Van der Weijden FA, Van der Sluijs E, Ciancio SG, Slot DE. Can Chemical Mouthwash Agents Achieve Plaque/Gingivitis Control? Dent Clin North Am. 2015 Oct;59(4):799-829. doi: 10.1016/j.cden.2015.06.002.

  PMID: 26427569 BACKGROUND

• Singaraju A, Nuvvula S, Rudravaram VR, Anchala K, Venkata Saikiran K, Mallineni SK. Efficacy of Triphala and Chlorhexidine Mouthwashes on Gingival Inflammation and Dental Plaque in Children: A Systematic Review. Oral. 2024 Nov 18;4(4):567-77.

  BACKGROUND

• Shetty, Vabitha, Srikala Bhandary, and Roleen Pereira. "Evaluation of antiplaque and antimicrobial activity of Cocoa Bean Extract: An in vivo study." World 12.2 (2021): 151.

  BACKGROUND

• Sharma A, Bansal P, Grover A, Sharma S, Sharma A. Oral health status and treatment needs among primary school going children in Nagrota Bagwan block of Kangra, Himachal Pradesh. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):762-6. doi: 10.4103/0972-124X.147421.

  PMID: 25624634 BACKGROUND

• Bhattacharjee R, Nekkanti S, Kumar NG, Kapuria K, Acharya S, Pentapati KC. Efficacy of triphala mouth rinse (aqueous extracts) on dental plaque and gingivitis in children. J Investig Clin Dent. 2015 Aug;6(3):206-10. doi: 10.1111/jicd.12094. Epub 2014 May 22.

  PMID: 24850703 BACKGROUND

• Minervini G, Marrapodi MM, Tirupathi S, Afnan L, Di Blasio M, Cervino G, Isola G, Cicciu M. Comparative anti-plaque and anti-gingivitis efficiency of Triphala versus chlorhexidine mouthwashes in children: a systematic review and meta-analysis. J Clin Pediatr Dent. 2024 Sep;48(5):51-59. doi: 10.22514/jocpd.2024.103. Epub 2024 Sep 3.

  PMID: 39275820 BACKGROUND

• Fan W, Liu C, Zhang Y, Yang Z, Li J, Huang S. Epidemiology and associated factors of gingivitis in adolescents in Guangdong Province, Southern China: a cross-sectional study. BMC Oral Health. 2021 Jun 16;21(1):311. doi: 10.1186/s12903-021-01666-1.

  PMID: 34134691 BACKGROUND

• Fahim MFM, Zarnigar P. Effect of prepared herbal mouthwash in maintaining the oral health of school children: A single-blind randomised control trial. Explore (NY). 2024 Jul-Aug;20(4):535-543. doi: 10.1016/j.explore.2023.12.003. Epub 2023 Dec 15.

  PMID: 38594113 BACKGROUND

• Poppolo Deus F, Ouanounou A. Chlorhexidine in Dentistry: Pharmacology, Uses, and Adverse Effects. Int Dent J. 2022 Jun;72(3):269-277. doi: 10.1016/j.identj.2022.01.005. Epub 2022 Mar 12.

  PMID: 35287956 BACKGROUND

• Chrysanthakopoulos, N. A. (2016). Prevalence of gingivitis and associated factors in 13-16-year-old adolescents in Greece. European Journal of General Dentistry, 5(02), 58-64

  BACKGROUND

• Bhat N, Mitra R, Oza S, Mantu VK, Bishnoi S, Gohil M, Gupta R. The antiplaque effect of herbal mouthwash in comparison to chlorhexidine in human gingival disease: a randomized placebo controlled clinical trial. J Complement Integr Med. 2014 Jun;11(2):129-37. doi: 10.1515/jcim-2014-0002.

  PMID: 24698829 BACKGROUND

• 3. Bhat, N., Ruchi Mitra, R. M., Reddy, J. J., Swapnil Oza, S. O., & Vinayak, K. M. (2013). Evaluation of efficacy of chlorhexidine and a herbal mouthwash on dental plaque: an in vitro comparative study

  BACKGROUND

• Barnett ML. The role of therapeutic antimicrobial mouthrinses in clinical practice: control of supragingival plaque and gingivitis. J Am Dent Assoc. 2003 Jun;134(6):699-704. doi: 10.14219/jada.archive.2003.0255.

  PMID: 12839405 BACKGROUND

• Pari A, Ilango P, Subbareddy V, Katamreddy V, Parthasarthy H. Gingival diseases in childhood - a review. J Clin Diagn Res. 2014 Oct;8(10):ZE01-4. doi: 10.7860/JCDR/2014/9004.4957. Epub 2014 Oct 20.

  PMID: 25478471 BACKGROUND

• Dandekar NV, Winnier JJ. Assessment of Antiplaque and Anti-Gingivitis Efficacy of Mouthwashes Prepared from Neem and Mango Extracts. Front Dent. 2020 Jun 20;17:11. doi: 10.18502/fid.v17i11.4128. eCollection 2020.

  PMID: 35968157 BACKGROUND

• Bajaj N, Tandon S. The effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation, and microbial growth. Int J Ayurveda Res. 2011 Jan;2(1):29-36. doi: 10.4103/0974-7788.83188.

  PMID: 21897640 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

hexitol

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mariam Mohsen Aly

  Finalizing the study design, revising the protocol, helping with the methodology, solving the existing problems, and revising the final version of the thesis.

  STUDY CHAIR

Central Study Contacts

Nourhan Emad El shenawy

CONTACT

+20 1118453355; nourhan.emad@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

EG (1)