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Role of Kefir Mouth Wash in Oral Health Status Amelioration

NCT06900881 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-24

No results posted yet for this study

Summary

The present research aims to evaluate the efficiency of kefir mouthwash in enhancing oral health status by employing an in vivo experimental approach. Specifically, the study will assess how kefir mouthwash influences key oral health indicators, including gingival inflammation, plaque development, oral hygiene status, and halitosis. The study will be conducted over a 28-day period, with follow-up assessments every 14 days. The study will include systemically healthy adults with moderate gingivitis. Clinical parameters such as the Gingival Index (GI), Plaque Index (PI), and Simplified Oral Hygiene Index (OHI-S) will be measured, along with inflammatory biomarkers, including Interleukin-1β (IL-1β) and Interleukin-10 (IL-10). Halitosis will be evaluated using a Hali meter device. All of these will be measured at base line and day 14 and day 28 end of the study. Chlorhexidine 0.12% will be used as a comparative control to evaluate the efficacy of kefir mouthwash in improving oral health. This research intends to provide scientific evidence supporting the use of kefir as a probiotic-based mouthwash, offering a natural alternative to chemical mouthwashes and potentially reducing the negative consequences commonly associated with their use.

Conditions

  • Plaque Induced Gingivitis
  • Halitosis
  • Oral Disease

Interventions

COMBINATION_PRODUCT

Kefir Mouth Wash

A kefir-based mouthwash was developed with active bacterial and yeast cultures, including Lactococcus lactis, Lactococcus cremoris, Lactococcus diacetylactis, Lactobacillus acidophilus, Saccharomyces cerevisiae, and Kluyveromyces lactis, along with maltodextrin and 3% fat milk. The recipe also calls for milk from Pegah, Iran. The milk is initially heated to boiling point and then allowed to cool to room temperature (25°C). After cooling, the kefir powder will be dissolved in the cooled milk and mixed well. For every 1 liter of milk, 3g of kefir starter yogurt (Yogourmet, France) will be added. The inoculated milk will then be transferred into a clean, airtight container, and the lid will be sealed. The container will be left at room temperature for approximately 24 hours until the kefir curd forms. After 24 hours, the kefir will be refrigerated for about 8 hours to halt the fermentation process.

DRUG

Chlorhexidine 0,12%Biofresh Mouthwash

Chlorhexidine mouthwash is used as a standard treatment (Scitra Co for Biofresh LIC, P.O. Box 87218, Dubai, U.A.E.). It contains 0.12% Chlorhexidine Digluconate, purified water, sodium saccharin, cremophor, flavor, and glycerin.

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Principal Investigators

  • Zahra H Al-Tamimi, MS student · Department of prevention, College of dentistry , University of Mustansiriyah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-06
Primary Completion
2025-09-10
Completion
2025-10-10

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900881 on ClinicalTrials.gov