구강 프로바이오틱스 Weissella cibaria CMU의 구취 및 치주염에 대한 효과: 무작위 이중맹검 위약대조 임상연구 = Effects of the oral probiotic Weissella cibaria CMU on halitosis and periodontitis: a randomized, double-blind, placebo-controlled trial

다국어 초록 (Multilingual Abstract)

Effects of the oral probiotic Weissella cibaria CMU on halitosis and periodontitis : a randomized, double-blind, placebo-controlled trial

Seung-Kyu Lee

Advisor: Prof. Won-Pyo Lee, Ph.D. Department of Dentistry Graduate School of Chosun University

I. Background
Halitosis is frequently accompanied by periodontal inflammation and can impair oral health-related quality of life. Oral probiotics have been proposed as a noninvasive adjunctive strategy for halitosis management; however, their effects are strain-specific, and evidence on whether improvement in halitosis is accompanied by a reduction in periodontal pathogen load remains limited. This study aimed to evaluate the effects of the oral probiotic Weissella cibaria CMU （OraCMU） on halitosis and on changes in periodontal pathogens in adults with gingivitis or early （Stage I–II） periodontitis.

II. Materials and Methods
This study was conducted as a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Eighty adults with halitosis were randomly assigned to either the OraCMU group （n = 40） or the placebo group （n = 40）, and participants slowly dissolved one tablet in the mouth twice daily for 8 weeks. Halitosis-related assessments, including volatile sulfur compounds （VSC） and the organoleptic test （OLT）, were performed at baseline, week 4, and week 8, and participant-reported bad breath improvement （BBI） was assessed at weeks 4 and 8. At baseline and week 8, nine periodontal pathogens were quantified using multiplex real-time quantitative polymerase chain reaction, and the periodontal pathogen index （PPI） and PPI level were calculated. Oral health-related quality of life was assessed using the Oral Health Impact Profile-14 （OHIP-14）. The primary endpoint of this thesis was the change in total VSCs concentration from baseline to week 8.

III. Results
Of the 80 randomized participants, 77 completed the study and were included in the final efficacy analysis, comprising 40 participants in the OraCMU group and 37 in the placebo group. At week 8, the baseline-adjusted reduction in total VSCs concentration was significantly greater in the OraCMU group than in the placebo group （−9.96 ± 1.60 vs. −1.96 ± 1.67 ng/10 mL; P = 0.001）. Hydrogen sulfide （H₂S） （−4.32 ± 0.73 vs. −0.99 ± 0.76 ng/10 mL; P = 0.003） and methyl mercaptan （CH₃ SH） （−5.60 ± 0.93 vs. −1.02 ± 0.97 ng/10 mL; P = 0.001） also decreased significantly more in the OraCMU group than in the placebo group. In addition, the OraCMU group showed significant improvements in OLT and BBI scores compared with the placebo group. In the microbiological analysis, the PPI and PPI level decreased significantly in the OraCMU group, and at week 8 the levels of P. gingivalis, P. intermedia, and T. denticola were significantly lower than in the placebo group. The total OHIP-14 score improved significantly within the OraCMU group, but the between-group difference was not significant.

IV. Conclusion
Eight weeks of OraCMU intake improved major objective and subjective halitosis parameters and reduced the periodontal pathogen load in adults with halitosis and gingivitis or early （Stage I–II） periodontitis. These findings suggest that OraCMU may serve as a useful adjunctive oral probiotic for halitosis management by modulating the oral microbial environment. However, further studies including long-term follow-up are needed to confirm the durability of the effect and its clinical applicability.

목차 (Table of Contents)

• I. 서론 1
• II. 실험 재료 및 방법 5
• 1. 연구 설계 및 윤리적 고려 5
• 2. 연구 참가자 5
• 3. 표본수 산정 6
• 4. 무작위 배정, 배정 은폐 및 눈가림 6
• 5. 중재 및 위약 대조 6
• 6. 연구 결과변수 및 평가 일정 7
• 7. 구취 관련 평가 7
• 7.1 휘발성 황화합물 측정 7
• 7.2 관능검사 8
• 7.3 구취 개선도 8
• 8. 임상 치주지수 8
• 9. 미생물학적 평가 및 치주병원균 지수 9
• 10. 구강건강 관련 삶의 질 평가 9
• 11. 안전성 평가 9
• 12. 통계 분석 10
• III. 결과 11
• 1. 참가자 흐름 및 기저 특성 11
• 2. 구취 관련 변수의 변화 13
• 2.1 휘발성 황화합물 16
• 2.2 관능검사 17
• 2.3 구취 개선도 17
• 3. 치주병원균 및 치주병원균 지수 18
• 4. 구강건강 관련 삶의 질 21
• IV. 고찰 23
• V. 결론 29
• 참고문헌 31