A Phase 3 interventional study of 0.12% Chlorhexidine Mouthwash ( Hexitol ) and Triphila mouthwash in Plaque Accumulation and Gingival Inflammation, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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.
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:
Benefits of the study to the community:
Benefits of the study for clinicians:
Study Setting and Location
The principal investigator will perform all clinical procedures as follows:
Preoperative diagnostic procedures:
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.
= 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.
=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
Sample size calculation:
In a previous study by Shetty et al in 2021, the plaque index within the chlorohexidine group was normally distributed with a standard deviation of 0.94 after 21 days. If the true difference between the two groups is 1, we will need to study 15 children per group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of the null hypothesis is 0.05. The sample size was increased by 20% to compensate for possible dropouts to reach 18 children per group. Sample size was calculated using PS Power and Sample for Windows version 3.1.6 using an independent t-test.
Recruitment and Recruitment Strategy:
Patients attending the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt, will be screened by the principal investigator until the target population is achieved. The patients will be subjected to a full examination and diagnosis using dental charts. Once the patients who are potentially eligible for this study are identified, they will be contacted by the principal investigator, who will explain the study and ascertain the patient's interest. If interested, more detailed evaluations and preparations will be made.
Assignment of interventions
Allocation:
Random sequence Generation:
The assistant supervisor will generate a random sequence using http://www.random.org/.
Allocation Concealment Mechanism:
The assistant supervisor will write the assigned group on a four-folded white paper and place it in a closed white envelope.
Implementation:
The participant will draw an envelope offered by the clinic nurse, and the patient's name will be written on it.
Blinding:
The trial participants, outcome assessors, and statisticians will be blinded.
Bias:
Baseline data collection:
Baseline data collection plans for assessment and collection of outcomes will be at 2 weeks and 3 weeks clinically by visual examination using a mirror and probe, and will be performed by two blinded assessors independently, and differences will be solved by consensus. To promote the quality of data, duplicate measurements by the same examiner (intra-examiner agreement) and training of assessors (inter-examiner agreement) will be done.
Data management:
The data will be entered into and stored on a personal computer. Another copy of the data will be saved on an external hard disc to prevent its loss.
Statistical analysis:
Data will be analyzed using Medcalc software, version 22 for Windows (MedCalc Software Ltd, Ostend, Belgium). Data will be explored for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Continuous data will be described using mean and standard deviation. Intergroup comparison will be performed using the independent t-test, and intragroup comparison will be performed using repeated measures ANOVA, followed by Bonferroni-corrected pairwise comparisons. A P-value less than or equal to 0.05 will be considered statistically significant, and all tests will be two-tailed.
Monitoring :
The supervisors will frequently monitor the study's results, having complete access to the interim results, and will make the ultimate decision about the termination of the trial.
Harms:
Auditing:
The trial procedure and documentation will be regularly assessed by study supervisors. They will be involved in participant enrolment, consent, eligibility, and allocation to study groups; adherence to trial interventions and policies to protect participants, including reporting of complications and their treatments. They will supervise the performance of clinical procedures.
Research ethics approval :
This protocol, the template, and specific informed consent forms (local language and English versions) will be reviewed, approved, and agreed upon by the Research Ethics Committee will review all the nature of the interventions and will have the right to modify the study methods.
Protocol amendments :
The Ethics Committee will be notified of any administrative changes or modifications to the protocol. Any required changes during the trial period for the patient's interest that might affect the conduct of the study, including changes in the study objectives, study design, patient population, sample sizes, and intervention procedures, will require a formal amendment to the protocol. Such an amendment will be agreed upon by the Council of the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University.
Informed consent:
The investigator will discuss the trial with the legal guardian of each participating child:
Confidentiality :
All data, information, participants' personal information, family history, and social and medical history will be stored in the files assigned to each patient with limited access to a minimum number of individuals necessary for quality control, audit, and analysis.
Declaration of interest :
This study is a part of a master's degree in Pediatric Dentistry, Faculty of Dentistry, Cairo University. No financial conflict of interest is confirmed. The study is self-funded by the principal investigator.
Access to data:
The investigator will be given access to data sets. All data sets will be password-protected. To ensure confidentiality, data dispersed to project team members will be blinded to any identifying participant information.
Post-trial care :
The investigator will offer full-mouth treatment, post-operative care, and preventive measures to all participants.
Dissemination policy:
The Thesis defense will be done as the study is a part of the requirements for a master's degree in Pediatric Dentistry.
Biological specimens:
There is no collection, laboratory evaluation, or storage of biological specimens in this study.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's planned enrollment of 36 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 0.12% Chlorhexidine Mouthwash ( Hexitol )
Drug: Triphila 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.
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
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
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
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Cairo University