Safety and Efficacy Evaluation of Mouth Wash(Glister Mouth Wash): Pilot Study

The goal of this clinical trial is to examine the efficacy of mouthwash containing 0.045% cetylpyridinium chloride (CPC) on oral health-related parameters] in [healthy conditions]. The main question[s] it aims to answer are:

• [ Trial 1: effect of immediate-use mouthwash containing CPC vs. non-CPC]
• [Trial 2: effect of concentrated-use mouthwash containing CPC vs. non-CPC] Participants will be treated by mouth wash 3 times a day for 4-weeks If there is a comparison group: Researchers will compare CPC containing mouthwash group and sham mouthwash groups treated with non CPC-containing mouthwash to see the effect of CPC on plaque index, mouth smell, gingival index and tongue coating index.

Study Overview

• Status: Completed
• Conditions: Oral Hygiene; Gingival Index; Cetylpyridinium Chloride
• Intervention / Treatment: Other: mouthwash

Detailed Description

2.1. Participants In all, 100 subjects were recruited to this clinical study according to the following inclusion criteria: i) Healthy male or female; ii) presence of >20 existing teeth (the number of remaining teeth); iii) no severe pathological soft tissue conditions, periodontitis, or extensive dental plaque; iv) Turesky modification of the Quigley-Hein Plaque Index (PI) of over 1.5 and Loe & Silness Gingival Index (GI) of over 1.5; vi) able to perform oral care/hygiene tasks on his/her own; vii) voluntary participation; and viii) willing to comply with the test protocol. Participants were excluded if they had any kind of visible or known disease requiring prophylactic antibiotic use.

2.2. Study design This was a randomized, controlled, double-blind clinical trial, and the intervention was gargling with the OR twice daily. The participants were randomly divided into four groups: control 1 (C1) (n=19), immediate-use CPC (IUC) (n=16), control 2 (C2) (n=19), and concentrated-use CPC (CUC) groups (n=19). Both C1 and C2 received ORs without CPC, whereas the experimental groups IUC and CUC received CPC ORs of different formulations (Amway Korea Ltd., Seoul, Republic of Korea). Randomized clinical trials (RCTs) are analyzed according to the intention-to-treat (ITT) principle and the per-protocol (PP) approach. ITT aims to assess the experimental design and PP analysis investigates the effect of receiving an assigned treatment. The participants underwent dental scaling before starting the intervention. Ethical approval was granted by the Institutional Research Ethics Review Board, Yonsei University, Wonju Severance Christian Hospital (IRBN CR321058) 2.3. Intervention After obtaining baseline information and randomizing the participants into two groups, dental scaling was performed, followed by clinical treatment. The participants were instructed to gargle twice daily for 7 days. All the participants were instructed not to eat or drink anything for at least 4 hours before the experiment. Oral hygiene, such as gargling and tooth brushing, was prohibited for 8 hours before the visit.

2.4. Measurment of H2S and methyl mercaptan, Quigley-Hein plaque index, Gingival Index,Tongue Coating Index.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ganwon-do
    • Wonju, Ganwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female;
• presence of >20 existing teeth (the number of remaining teeth);
• no severe pathological soft tissue conditions, periodontitis, or extensive dental plaque;
• Turesky modification of the Quigley-Hein Plaque Index (PI) of over 1.5 and Loe & Silness Gingival Index (GI) of over 1.5; • able to perform oral care/hygiene tasks on his/her own;
• voluntary participation; and viii) willing to comply with the test protocol.

Exclusion Criteria:

• They excluded if they had any kind of visible or known disease requiring prophylactic antibiotic use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: experimental group; CPC-containing mouthwash solution

Other: mouthwash; After obtaining baseline information and randomizing the participants into two groups, dental scaling was performed, followed by clinical treatment. The participants were instructed to gargle twice daily for 7 days. All the participants were instructed not to eat or drink anything for at least 4 hours before the experiment. Oral hygiene, such as gargling and tooth brushing, was prohibited for 8 hrs before the visit.; Other Names: Glister mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hydrogen sulfide(H2S) and methyl mercaptan(CH3SH)	in the pretreatment versus post-treatment comparisons of the groups, levels of H2S (p < 0.01) and CH3SH (p < 0.01) were reduced significantly in cpc-containing mouthwash group (immediate-use and concentrated-use mouthwash) comparing non-CPC containing sham mouthwash.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quigley-Hein plaque index	the PI had decreased in all groups (Figure 3A). However, the IUC group showed significant antiplaque effects compared with the C1 group (p < 0.05). Improvement in periodontal health was seen 14 days after treatment, which was not observed in the CUC group (Figure 3B). Since OR without CPC also improved periodontal health, we further examined the group on day 28 of the trial. In addition, after 28 days, the CUC group showed antiplaque effects (p < 0.05). Overall, the IUC showed superior antiplaque activity and faster periodontal health-promoting effects than the CUC and control formulations.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival index	the highest increase in gingival health was observed 28 days after IUC administration (p < 0.05) (Figure 4A). Similar to the results for the PI, we did not observe significant changes in the gingival health of the C1 and C2 groups. As expected, gingival health improved significantly in the CUC group compared to in the C2 group, which was observed on study days 14 and 28 (Figure 4B).	4 weeks

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Investigators: Study Chair: Kyu-Jae Lee, Ph.D., Wonju College of Medicine, Yonsei University, Republic of Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: mouthwash, cetylpyridinium chloride, oral hygiene
• Other Study ID Numbers: EMB-2020-02; 2020-51-0447 (Other Grant/Funding Number: Amway Korea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No