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

Oral Hygiene Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644236
• Other study ID #: EMB-2020-02
• Secondary ID: 2020-51-0447
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cetylpyridinium Chloride
• Oral Hygiene

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Ganwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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