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Completed

NCT Number: NCT05211219

The Role of Probiotics in Periodontal Disease

In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Dentistry, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy
  • Individuals over 18
  • Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
  • Non-smoker
  • Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.

Exclusion criteria

  • Antibiotic use within 6 months.
  • Breastfeeding or pregnancy.
  • Acute oral lesions or necrotizing ulcerative periodontitis
  • Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
  • Patients who smoke or who did not stop until last year
  • Use of probiotics tablets or capsules
  • Probiotic food consumption not more than 3-4 times a week

Treatment and study plan

Probiotics

Dietary Supplement

According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; the probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements.

Other names: Probest Defense

AOÇ Kefir

Dietary Supplement

AOÇ Kefir

Food without additional food supplements

Other

Food without additional food supplements

Primary outcomes

  1. Periodontal probing depth

    Time frame: Baseline

    the distance from the gingival margin to pocket base.

  2. Periodontal probing depth

    Time frame: 1st month

    the distance from the gingival margin to pocket base.

  3. Periodontal probing depth

    Time frame: 3rd month

    the distance from the gingival margin to pocket base.

  4. Gingival index

    Time frame: Baseline

    It is an index that shows the severity and quantity of gingival inflammation.

  5. Gingival index

    Time frame: 1st month

    It is an index that shows the severity and quantity of gingival inflammation.

  6. Gingival index

    Time frame: 3rd month

    It is an index that shows the severity and quantity of gingival inflammation.

  7. Microbiological sample

    Time frame: Baseline

    Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.

  8. Microbiological sample

    Time frame: 1st month

    Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.

  9. Microbiological sample

    Time frame: 3rd month

    Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia, Porphyromonas gingivalis, and Treponema denticola.

  10. Plaque index

    Time frame: Baseline

    It is an index that shows the amount of microbial dental plaque on the teeth.

  11. Plaque index

    Time frame: 1st month

    It is an index that shows the amount of microbial dental plaque on the teeth.

  12. Plaque index

    Time frame: 3rd month

    It is an index that shows the amount of microbial dental plaque on the teeth.

  13. Bleeding on probing

    Time frame: Baseline

    Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

  14. Bleeding on probing

    Time frame: 1st month

    Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

  15. Bleeding on probing

    Time frame: 3rd month

    Bleeding that is induced by gentle manipulation of the tissue at the depth of the gingival sulcus.

Secondary outcomes

  1. Clinical attachment level

    Time frame: Baseline

    The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.

  2. Clinical attachment level

    Time frame: 1st month

    The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.

  3. Clinical attachment level

    Time frame: 3rd month

    The clinical attachment level is the distance between the enamel-cementum junction and the gingival sulcus.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Role of Probiotics in Preventing Dysbiosis in Periodontal Disease

Acronym: tropipd

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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