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

NCT06963788 | Completed Phase 3 DMC

• 2 other identifiers: 23.134.SV/PCTHĐĐĐ23.KR.005
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dental Plaque and Gingivitis

Keywords

preventative dentistry; dental plaque; mouthwash

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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)

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

Study Arms (3)

Group I (Control group)

PLACEBO COMPARATOR

This group uses 0.9% sodium chloride

Drug: 0,9% Chloride Sodium

Group II

ACTIVE COMPARATOR

This group uses 0.12% CHX mouthwash

Drug: Chlorhexidine 0,12%

Group III

ACTIVE COMPARATOR

This group uses AgNPs mouthwash

Drug: Silver nanoparticles mouthwash

Interventions

Chlorhexidine 0,12% DRUG

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

Also known as: CHX mouthwash

Group II

0,9% Chloride Sodium DRUG

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

Also known as: NaCl 0,9%

Group I (Control group)

Silver nanoparticles mouthwash DRUG

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

Also known as: AgNPs mouthwash

Group III

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Vietnam

Location

Related Publications (2)

• Maher 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

  BACKGROUND

• 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.

  PMID: 5237684 BACKGROUND

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Thao Do, Assoc. Prof.

  Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 9, 2025
• Study Start: February 6, 2024
• Primary Completion: April 15, 2024
• Study Completion: December 31, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

VN (1)