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

NCT05644236 | Completed

• 2 other identifiers: EMB-2020-022020-51-0447
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Hygiene; Gingival Index; Cetylpyridinium Chloride

Keywords

mouthwash, cetylpyridinium chloride, oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quigley-Hein plaque index

  4 weeks

Other Outcomes (1)

• Gingival index

  4 weeks

Study Arms (1)

experimental group

EXPERIMENTAL

CPC-containing mouthwash solution

Other: mouthwash

Interventions

mouthwash OTHER

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.

Also known as: Glister mouthwash

experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Ganwon-do, 26426, South Korea

Location

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kyu-Jae Lee, Ph.D.

  Wonju College of Medicine, Yonsei University, Republic of Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Mouthwah solution was provided by sponsor who packed experimental and control solution in the bottle. Investigator and participants did not know the contents during treatment period.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 9, 2022
• Study Start: September 27, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)