Dental Plaque and GingivitisPhase 3mouthwashNCT06963788
The Comparative Effects of Using 0.12% Chlorhexidine and Silver Nanoparticles Mouthwashes in Medical Students
A Phase 3 study testing Chlorhexidine 0,12%, 0,9% Chloride Sodium and Silver nanoparticles mouthwash in people with Dental Plaque and Gingivitis, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque and Gingivitis
- What is being tested?
- Chlorhexidine 0,12%, 0,9% Chloride Sodium and Silver nanoparticles mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteVietnam
- Study dates
- 6 Feb 2024to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Interventional Study in Southern Vietnam: 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Dental Plaque and Gingivitis
- Being tested
- Chlorhexidine 0,12%, 0,9% Chloride Sodium, Silver nanoparticles mouthwash
- Keywords
- preventative dentistry, dental plaque, mouthwash
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine 0,12%Drug
Also called CHX mouthwash
Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes
0,9% Chloride SodiumDrug
Also called NaCl 0,9%
Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes
Silver nanoparticles mouthwashDrug
Also called AgNPs mouthwash
Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group I (Control group) | Placebo comparator | This group uses 0.9% sodium chloride Receives: Drug: 0,9% Chloride Sodium |
| Group II | Active comparator | This group uses 0.12% CHX mouthwash Receives: Drug: Chlorhexidine 0,12% |
| Group III | Active comparator | This group uses AgNPs mouthwash Receives: Drug: Silver nanoparticles mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Plaque Control Effectiveness After 21 Days of Use Between Two Types of Mouthwash: Chlorhexidine 0.12% and Silver Nanoparticles
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
Measured: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21
Comparison of the Effectiveness of Reducing Gingivitis After 21 Days of Use Between Two Mouthwashes: Chlorhexidine 0.12% and Silver Nanoparticles
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.
Measured: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21
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.
Method: The number of colonies growing on culture media was determined by counting colony-forming units (CFU).
Unit of measurement: CFU/mL
Measured: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21
Comparison of the effectiveness of pH control in saliva after 21 days of use between two mouthwashes: Chlorhexidine 0.12% and silver nanoparticles
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)
Measured: From the initiation of mouthwash use on Day 1 until the completion of the intervention on Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start6 Feb 2024
- Primary completion15 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Plaque and GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thao Do, Assoc. Prof., Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963788
- Sponsor's protocol ID
- 23.134.SV/PCTHĐĐĐ
- Other IDs
- 23.KR.005
- Acronym
- mouthwash
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684Maher Y.A., Fathi A., Sembawa B.A., Elkhyat S.H., Hafiz H.F., et al. Effectiveness of Mouthwash-Containing Silver Nanoparticles on Cariogenic Microorganisms, Plaque Index, and Salivary pH in A Group of Saudi Children. The Open Dentistry Journal, (2022), 16, https://doi.org/10.2174/18742106-v16-e2209090
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Interventional Study in Southern Vietnam: the Comparative Effects of Using 0.12% Chlorhexidine and Silver Nanoparticles Mouthwashes in Medical Students
- ClinicalTrials.gov ID
- NCT06963788
- Acronym / sponsor ID
- mouthwash / 23.134.SV/PCTHĐĐĐ
- Conditions
- Dental Plaque and Gingivitis
- Keywords
- preventative dentistry, dental plaque, mouthwash
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Control group) | Placebo comparator | Drug: 0,9% Chloride SodiumThis group uses 0.9% sodium chloride |
| Group II | Active comparator | Drug: Chlorhexidine 0,12%This group uses 0.12% CHX mouthwash |
| Group III | Active comparator | Drug: Silver nanoparticles mouthwashThis group uses AgNPs mouthwash |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine 0,12%Also: CHX mouthwashRinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes | Drug | Group II |
| 0,9% Chloride SodiumAlso: NaCl 0,9%Rinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes | Drug | Group I (Control group) |
| Silver nanoparticles mouthwashAlso: AgNPs mouthwashRinse mouth with 10ml for 30 seconds after brushing teeth for 30 minutes | Drug | Group III |
Primary outcome
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
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.
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Results publicationMaher Y.A., Fathi A., Sembawa B.A., Elkhyat S.H., Hafiz H.F., et al. Effectiveness of Mouthwash-Containing Silver Nanoparticles on Cariogenic Microorganisms, Plaque Index, and Salivary pH in A Group of Saudi Children. The Open Dentistry Journal, (2022), 16, https://doi.org/10.2174/18742106-v16-e2209090
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thao Do, Assoc. Prof. principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine 0,12%, 0,9% Chloride Sodium and Silver nanoparticles mouthwash in people with Dental Plaque and Gingivitis, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.