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

NCT ID: NCT05644236

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Oral Hygiene; Gingival Index; Cetylpyridinium Chloride

Keywords

mouthwash, cetylpyridinium chloride, oral hygiene

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

experimental group

CPC-containing mouthwash solution

Group Type: EXPERIMENTAL

mouthwash

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Glister mouthwash

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyu Jae Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu-Jae Lee, Ph.D.

Role: STUDY_CHAIR

Wonju College of Medicine, Yonsei University, Republic of Korea

Locations

Wonju Severance Christian Hospital

Wŏnju, Ganwon-do, South Korea

Countries

South Korea

Other Identifiers

2020-51-0447

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EMB-2020-02

Identifier Type: -

Identifier Source: org_study_id