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NCT Number: NCT06963788

The Comparative Effects of Using 0.12% Chlorhexidine and Silver Nanoparticles Mouthwashes in Medical Students

This double-blind, randomized intervention study aims to evaluate and compare the efficacy of 0.12% Chlorhexidine (CHX) mouthwash and Nano Silver (AgNPs) mouthwash. Specifically, it seeks to address the following research questions:

How effective are 0.12% CHX and AgNPs mouthwashes in controlling dental plaque accumulation, reducing gingival inflammation, and maintaining salivary pH balance?

How do these two mouthwashes compare in terms of relevant clinical parameters?

The study design includes three groups: Group I (control), which will receive 0.9% sodium chloride (saline solution); Group II, which will receive 0.12% CHX mouthwash; and Group III, which will receive AgNPs mouthwash. Participants will be selected based on defined inclusion and exclusion criteria.

Subjects will be randomly assigned to one of the three groups, ensuring an even distribution of male and female participants. Clinical parameters will be recorded at baseline and after 21 days of intervention. These parameters include the Gingival Index (GI), the Quigley-Hein Plaque Index (QHI), microbial colony counts, and salivary pH levels.

Blinding was maintained throughout the study: neither participants nor clinical evaluators were aware of group assignments. The individual responsible for coding the mouthwash formulations was not involved in any other part of the study and disclosed the codes only after data analysis was completed.

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Key information

Conditions

Dental Plaque and Gingivitis Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Can Tho University of Medicine and Pharmacy

Can Tho, Vietnam

About this study

Sample collection procedure Before the study, participants underwent a comprehensive oral health screening to evaluate dental caries, inflammation, and other dental conditions. Participants were instructed to fast for 2 hours prior to the examination to ensure accurate results. The selection was based on specific inclusion and exclusion criteria, and baseline clinical characteristics were accurately recorded. At baseline (day 0), a detailed assessment of microbial counts was conducted. Saliva samples were cultured on agar plates with standardized volumes of 10 µL, diluted to concentrations of 1/100 and 1/1000. After incubation at 37°C for 24 hours, colony-forming units (CFUs) were counted, and the microbial density was calculated per milliliter of saliva, then converted to a logarithm (CFU/mL) for statistical analysis. Additionally, saliva pH was measured using a calibrated digital pH meter, equipped with an electrode and a temperature sensor (Hanna HI2211-02 Benchtop pH Meter, Italy). The level of plaque was assessed using the QHI. After 21 days of use (day 21), a reassessment was conducted to reflect the processes from day 0, including the reevaluation clinical parameters such as GI, QHI, microbial counts, and saliva pH Statistical analysis The assembled data were imported into Microsoft Excel 2020 and Google Drive software, followed by SPSS Statistics 22.0 for analysis and accomplishment he ANOVA, paired T-tests, and Tukey post-hoc tests were employed to analyze the study parameters at baseline and after 21 days of using mouthwash.

Study error The total number of colonies formed was counted and analyzed by a microbiologist. For parameters such as GI, QHI, and salivary pH, assessments were performed by a dentist. Investigators were blinded to the group assignments of the samples. The microbiologist's consistency was evaluated as follows: after the initial sample measurements were taken, 30 randomly selected samples were re-evaluated using the same method by the same individual (reproducibility test), approximately 30 minutes later. Similarly, the consistency of the dentist was assessed. Data from the second measurement were compared with the first using Pearson's correlation coefficient.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants were eligible for inclusion if they met all of the following conditions:

  • Had not used systemic antibiotics, corticosteroids, or mouthwash for at least 28 days prior to the start of the study;
  • Maintained stable oral and general health throughout the study period.

Exclusion criteria

Participants were excluded from the study if they met any of the following conditions:

  • Had incomplete data or demonstrated non-compliance with study protocols;
  • Presented with active oral infections;
  • Were undergoing ongoing orthodontic or cosmetic dental treatments;
  • Had systemic conditions such as autoimmune disorders, diabetes mellitus, hypertension, hematological diseases, or psychiatric disorders.

Treatment and study plan

Chlorhexidine 0,12%

Drug

Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes

Other names: CHX mouthwash

0,9% Chloride Sodium

Drug

Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes

Other names: NaCl 0,9%

Silver nanoparticles mouthwash

Drug

Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes

Other names: AgNPs mouthwash

Primary outcomes

  1. Comparison of Plaque Control Effectiveness After 21 Days of Use Between Two Types of Mouthwash: Chlorhexidine 0.12% and Silver Nanoparticles

    Time frame: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21

    Measurement Tool: Quigley-Hein Plaque Index (QHI)

    Measurement Tool Description:

    The Quigley-Hein Plaque Index (QHI) is a smooth surface index that assesses dental plaque by staining the plaque with a disclosing agent and categorizing it into six grades based on severity:

    Grade 0: No plaque present.

    Grade 1: Isolated islands of plaque.

    Grade 2: A clearly defined continuous plaque line at the gingival margin, extending up to 1 mm.

    Grade 3: Plaque covering the cervical third of the tooth.

    Grade 4: Plaque covering up to the middle third of the tooth.

    Grade 5: Plaque extending beyond the middle third and reaching the incisal or occlusal edge.

    Index Calculation:

    QHI is calculated by summing the severity grades and dividing by the total number of teeth evaluated, as follows:

    QHI = the severity levels/ Number of teeth used for evaluation

  2. Comparison of the Effectiveness of Reducing Gingivitis After 21 Days of Use Between Two Mouthwashes: Chlorhexidine 0.12% and Silver Nanoparticles

    Time frame: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21

    Measurement Tool: Gingival Index (GI)

    Description of the Measurement Tool:

    The presence of gingivitis was assessed using a periodontal probe and evaluated according to the Gingival Index (GI). The severity of gingival inflammation was categorized into four grades:

    Grade 0: Normal gingiva, with no signs of inflammation.

    Grade 1: Mild gingivitis, characterized by slight color changes and mild swelling of the gingiva, without bleeding upon probing.

    Grade 2: Moderate gingivitis, with redness, swelling, a shiny surface appearance, and bleeding upon gentle probing.

    Grade 3: Severe gingivitis, presenting with marked redness, swelling, ulceration, and spontaneous bleeding.

    The GI score for an individual tooth is determined by averaging the scores from four designated sites (buccal, lingual, mesial, and distal surfaces).

    The overall GI for an individual is calculated as the mean GI score across all examined teeth.

  3. Comparison of the effectiveness of reducing the number of bacteria in saliva after 21 days of use between two mouthwashes: Chlorhexidine 0.12% and silver nanoparticles.

    Time frame: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21

    Method: The number of colonies growing on culture media was determined by counting colony-forming units (CFU).

    Unit of measurement: CFU/mL

  4. Comparison of the effectiveness of pH control in saliva after 21 days of use between two mouthwashes: Chlorhexidine 0.12% and silver nanoparticles

    Time frame: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21

    Saliva pH was measured using a calibrated digital pH meter, equipped with an electrode and a temperature sensor (Hanna HI2211-02 Benchtop pH Meter, Italy)

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

Double-blind Interventional Study in Southern Vietnam: the Comparative Effects of Using 0.12% Chlorhexidine and Silver Nanoparticles Mouthwashes in Medical Students

Acronym: mouthwash

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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