Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 28Years
All Genders
Healthy Volunteers
ID06900881

Role of Kefir Mouth Wash in Oral Health Status Amelioration: An in Vivo Study

Led by Al-Mustansiriyah University · Updated on 2025-04-24

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of kefir mouthwash in improving oral health by studying its impact on gingival inflammation, plaque, oral hygiene, and bad breath in adults with moderate gingivitis. This trial compares kefir mouthwash to the standard chlorhexidine 0.12% mouthwash over a 28-day period, with assessments at the start, day 14, and day 28. The study uses a triple-blind, randomized design involving healthy adults aged 18 to 28 years. Participants will be randomly assigned to use either kefir mouthwash or chlorhexidine. Kefir mouthwash is prepared from probiotic cultures mixed with 3% fat milk and used twice daily, 30 minutes after brushing, for one minute each time. The chlorhexidine group uses 0.12% chlorhexidine mouthwash following the same schedule and instructions. Both mouthwashes are provided in identical bottles labeled only by codes to maintain blinding. During the trial, researchers will measure oral health using the Gingival Index, Plaque Index, Simplified Oral Hygiene Index, and halitosis levels with a Hali Meter. Saliva samples will be collected to analyze inflammatory markers IL-1b2 and IL-10 at baseline, day 14, and day 28. Participants' adherence will be monitored through daily logs, electronic reminders, and follow-up visits. Non-compliance may lead to exclusion from the study.

CONDITIONS

Brief Title

Role of Kefir Mouth Wash in Oral Health Status Amelioration

Who Can Participate

Age: 18Years - 28Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age range 18-28 years.
  • Systemically healthy people without a history of chronic illness.
  • Those suffering with moderate gingivitis.
  • Not using any antibiotics over three months
Not Eligible

You will not qualify if you...

  • History of systemic diseases.
  • Pregnant, lactating females.
  • History of antibiotic therapy in the past 3 months.
  • History of oral prophylaxis within the last 6 months prior to the study as this can confound the results, making it difficult to determine the real effect of the mouthwash.
  • Subjects with mouth breathing habits.
  • Subjects with orthodontic and prosthodontic appliances.
  • Subjects with deleterious habits such as smoking, because it may affect oral health status, causing periodontal disease, altered oral microbiota, and impaired healing. This can confound the study results, making it difficult to observe the mouthwash effect .
  • Failure to follow the prescription regimen.
  • Failure to follow the research protocol.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 28 days

Participants use either kefir mouthwash or chlorhexidine mouthwash twice daily for 1 minute, 30 minutes after brushing their teeth. They are advised not to eat or drink for one hour after use. This treatment lasts 28 days.

3 visits (Day 0, Day 14, and Day 28) for assessments including oral health indices, saliva collection, and halitosis measurement

Trial Site Locations

Total: 1 location

1

Al-Mustansiriyah University/College of Dentistry

Baghdad, Iraq

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Research Team

Z

Zahra H Al-Tamimi, MS student

Z

Zahra H Al-Tamimi, MS student

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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