Effects of Two Daily CHX Mouthrinses on Plaque, Gingivitis and Staining

NCT07351370 | Completed Phase 3

• 1 other identifier: DentalSchool
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Τhe aim of this randomized clinical trial was to investigate the efficacy of two daily mouth rinses containing CHX and different combinations of H2O2 and CPC, when used adjunctive to mechanical oral hygiene, and compare them with a placebo mouth rinse. The primary outcomes evaluated were changes in i) bacterial biofilm accumulation, ii) gingival inflammation, and iii) tooth staining. Secondarily, patient's satisfaction and perspective after the use of these formulations was assessed.

Conditions

Chlorhexidine; Dental Plaque; Gingival and Periodontal Disease; Randomized Controlled Trial; Mouthwashes

Outcome Measures

Primary Outcomes (1)

• change in plaque index (PI)

  change in dental plaque accumulation assessed using the plaque index (PI)

  baseline, 1 month, 2 months and 3 months

Study Arms (3)

chlorhexidine 0.05% + cetylpyridinium chloride 0.05% and hydrogen peroxide 0.8%

EXPERIMENTAL

Participants rinsed twice daily for 3 months with a mouthwash containing chlorhexidine 0.05% + cetylpyridinium chloride 0.05% and hydrogen peroxide 0.8% , as adjunct to conventional mechanical oral hygiene. All participants received supragingival prophylaxis and oral hygiene reinforcement prior to the intervention.

Drug: chlorhexidine/ cetylpyridinium chloride/ hydrogen peroxide mouthwash

CHX 0.05% + CPC 0.05%

EXPERIMENTAL

Participants rinsed twice daily for 3 months with a mouthwash containing chlorhexidine 0.05% and cetylpyridinium chloride 0.05% , as adjunct to conventional mechanical oral hygiene. All participants received supragingival prophylaxis and oral hygiene reinforcement prior to the intervention.

Drug: Chlorhexidine/ cetylpyridinium chloride

placebo mouthwash

PLACEBO COMPARATOR

Participants rinsed twice daily for 3 months with placebo mouthwash, as adjunct to conventional mechanical oral hygiene. All participants received supragingival prophylaxis and oral hygiene reinforcement prior to the intervention.

Other: Placebo

Interventions

Placebo OTHER

All participants were instructed to rinse for 3 months for 1 minute twice a day with 15 ml of the provided solution

placebo mouthwash

Chlorhexidine/ cetylpyridinium chloride DRUG

All participants were instructed to rinse for 3 months for 1 minute twice a day with 15 ml of the provided solution

CHX 0.05% + CPC 0.05%

chlorhexidine/ cetylpyridinium chloride/ hydrogen peroxide mouthwash DRUG

All participants were instructed to rinse for 3 months for 1 minute twice a day with 15 ml of the provided solution.

chlorhexidine 0.05% + cetylpyridinium chloride 0.05% and hydrogen peroxide 0.8%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old)
• Presence of at least 24 teeth
• Presence of teeth #23-13 and #43-33
• Gingival Index (GI) ≤30% (Lindhe, 1981)
• No interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth or buccal/oral CAL ≥3 mm with probing pocket depth (PPD) \>3 mm at ≥2 teeth (Tonetti et al., 2019)
• No known allergy to chlorhexidine (CHX), hydrogen peroxide (H₂O₂), or cetylpyridinium chloride (CPC)
• No fixed or removable orthodontic appliances or removable prostheses
• No use of systemic antibiotics within the 3 months prior to the study
• Non-smokers or light smokers (\<5 cigarettes/day)
• Non-pregnant and non-lactating women
• Absence of crowns, fixed partial dentures, or class III/IV/V composite restorations covering more than one-third of the crown, and no deep dental caries extending into dentine

You may not qualify if:

• Presented with signs of hypersensitivity, severe irritation, or discomfort during the experimental period
• Were not compliant with the experimental protocol

Sponsors & Collaborators

• Dental School: lead

Study Sites (1)

NKUA School of Dentistry

Athens, Attica, Greece

Location

MeSH Terms

Conditions

Dental Plaque; Periodontal Diseases

Interventions

Chlorhexidine; Cetylpyridinium

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinding study. This means that neither the participants, their caregivers, nor the researchers processing the data or evaluating the results know which participant is receiving which of the three different mouth rinses. Additionally, it seems that the rinses were placed in plastic containers of the same color and labeling, so neither the participants nor the researchers know which container contains which rinse, achieving complete blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The interventional study model is a single-center, randomized, controlled, double-blind, parallel-design clinical trial spanning over 3 months. It compares the efficacy of two mouth rinses: 1) CHX 0.05% + CPC 0.05% + H2O2 0.8%, and 2) CHX 0.05% + CPC 0.05%, with a placebo. Participants undergo screening, sign consent forms, and receive oral hygiene instructions before being randomly allocated to one of the three groups. They rinse twice daily for 3 months, and oral health parameters are assessed at baseline and monthly intervals. Compliance is monitored, and potential side effects are evaluated. Participants provide feedback via a questionnaire at the trial's end.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 20, 2026
• Study Start: January 15, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

GR (1)