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CompletedNCT06871540Updated Mar 12, 2025

Evaluation of the Effect of Streptococcus Salivarius K12 Probiotic in the Treatment of Periodontitis

An interventional study of Probiotic Agent and Non-Surgical Intervention in Periodontitis Stage III and Probiotic, sponsored by AYŞENUR ŞAHİN. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by AYŞENUR ŞAHİN · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Oct 2023, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Aims: The use of oral probiotics as an adjunct to the treatment of periodontal diseases is known to be beneficial in antagonizing pathogenic microflora and regulating the host immune response. The aim of this clinical study was to evaluate the clinical, microbiologic and biochemical effect of Streptococcus salivarius (S. salivarius) K12 probiotic tablet as an adjunct to scaling and root planing (SRP) treatment in stage 3 periodontitis patients.

Methods: The study included 30 systemically healthy stage 3 periodontitis patients. After non-surgical periodontal treatment, participants were randomly assigned to the test (SRP+Probiotic, n=15) or control (SRP, n=15) group. Patients in the test group used probiotic tablets once daily for 30 days. Clinical (Plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)), microbiological (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, Aggregatibacter actinomycetemcomitans, Fusobacterium nucleatum) and biochemical (IL-6, IL-8, IL-10) measurements were performed at baseline (before SRP), 30. and 90th days. Data were analyzed statistically.

Keywords: Microbiology, Periodontitis, Probiotics, Cytokines

02

Conditions studied

  • Periodontitis Stage III
  • Probiotic

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Keywords

  • Microbiology, Periodontitis, Probiotics, Cytokines
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

This is the only study on the registry with AYŞENUR ŞAHİN as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female aged 18-60 years,
  • No systemic disease,
  • No periodontal treatment in the last 6 months,
  • No antibiotic therapy in the last 6 months,
  • Diagnosed with stage 3 periodontitis according to the 2017 periodontal disease classification

Exclusion criteria

Exclusion Criteria:

  • Periodontal treatment within sixteen months,
  • Smoking,
  • Patients with systemic health problems such as diabetes, rheumatoid arthritis, neurological diseases, lung and kidney diseases,
  • Pregnancy or lactation,
  • Acute oral lesions or necrotizing ulcerative periodontitis.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Test Grubu

    Other: Probiotic Agent · Other: Non-Surgical Intervention

  • Other
    Control

    Other: Non-Surgical Intervention

Interventions

  • OtherProbiotic Agent

    Patients in the test group were instructed to take one tablet immediately after tooth brushing (before bedtime) once daily for 30 consecutive days. Probiotic was administered in tablets containing 1x109 cfu/g S. salivarius K12.

  • OtherNon-Surgical Intervention

    Patients in the control group received non-surgical periodontal treatment only.

06

What researchers measure

Primary outcomes

  1. Reduction in Porphyromonas gingivalis at 3 months

    Time frame: From enrollment to the end of treatment at 12 weeks

07

Study locations

1 site
  • İnönü Üniversitesi Diş Hekimliği Fakültesi
    Malatya, Battalgazi, Turkey
08

References and documents

Publications

  • Haffajee AD, Cugini MA, Dibart S, Smith C, Kent RL Jr, Socransky SS. Clinical and microbiological features of subjects with adult periodontitis who responded poorly to scaling and root planing. J Clin Periodontol. 1997 Oct;24(10):767-76. doi: 10.1111/j.1600-051x.1997.tb00195.x. PubMed 9350562 ↗
  • Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721. PubMed 29926951 ↗
  • Servin AL, Coconnier MH. Adhesion of probiotic strains to the intestinal mucosa and interaction with pathogens. Best Pract Res Clin Gastroenterol. 2003 Oct;17(5):741-54. doi: 10.1016/s1521-6918(03)00052-0. PubMed 14507585 ↗
  • Morales A, Carvajal P, Silva N, Hernandez M, Godoy C, Rodriguez G, Cabello R, Garcia-Sesnich J, Hoare A, Diaz PI, Gamonal J. Clinical Effects of Lactobacillus rhamnosus in Non-Surgical Treatment of Chronic Periodontitis: A Randomized Placebo-Controlled Trial With 1-Year Follow-Up. J Periodontol. 2016 Aug;87(8):944-52. doi: 10.1902/jop.2016.150665. Epub 2016 Mar 4. PubMed 26944407 ↗
  • Darveau RP, Hajishengallis G, Curtis MA. Porphyromonas gingivalis as a potential community activist for disease. J Dent Res. 2012 Sep;91(9):816-20. doi: 10.1177/0022034512453589. Epub 2012 Jul 6. PubMed 22772362 ↗
  • Stamatova I, Meurman JH. Probiotics and periodontal disease. Periodontol 2000. 2009;51:141-51. doi: 10.1111/j.1600-0757.2009.00305.x. No abstract available. PubMed 19878473 ↗
  • Alanzi A, Honkala S, Honkala E, Varghese A, Tolvanen M, Soderling E. Effect of Lactobacillus rhamnosus and Bifidobacterium lactis on gingival health, dental plaque, and periodontopathogens in adolescents: a randomised placebo-controlled clinical trial. Benef Microbes. 2018 Jun 15;9(4):593-602. doi: 10.3920/BM2017.0139. Epub 2018 Apr 10. PubMed 29633646 ↗
  • Twetman S, Derawi B, Keller M, Ekstrand K, Yucel-Lindberg T, Stecksen-Blicks C. Short-term effect of chewing gums containing probiotic Lactobacillus reuteri on the levels of inflammatory mediators in gingival crevicular fluid. Acta Odontol Scand. 2009;67(1):19-24. doi: 10.1080/00016350802516170. PubMed 18985460 ↗
  • Rossi V, Romagna R, Angst PDM, Gomes SC. Gingival crevicular fluid response to protocols of non-surgical periodontal therapy: A longitudinal evaluation. Indian J Dent Res. 2019 Sep-Oct;30(5):736-741. doi: 10.4103/ijdr.IJDR_148_16. PubMed 31854365 ↗
  • Kowashi Y, Jaccard F, Cimasoni G. Sulcular polymorphonuclear leucocytes and gingival exudate during experimental gingivitis in man. J Periodontal Res. 1980 Mar;15(2):151-8. doi: 10.1111/j.1600-0765.1980.tb00269.x. No abstract available. PubMed 6445977 ↗
  • Ince G, Gursoy H, Ipci SD, Cakar G, Emekli-Alturfan E, Yilmaz S. Clinical and Biochemical Evaluation of Lozenges Containing Lactobacillus reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Chronic Periodontitis. J Periodontol. 2015 Jun;86(6):746-54. doi: 10.1902/jop.2015.140612. Epub 2015 Mar 5. PubMed 25741580 ↗
  • Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29. PubMed 26427036 ↗
  • Tekce M, Ince G, Gursoy H, Dirikan Ipci S, Cakar G, Kadir T, Yilmaz S. Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study. J Clin Periodontol. 2015 Apr;42(4):363-72. doi: 10.1111/jcpe.12387. Epub 2015 Apr 10. PubMed 25728888 ↗
  • Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15. PubMed 24164569 ↗
  • Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344. PubMed 21523225 ↗
  • Krasse P, Carlsson B, Dahl C, Paulsson A, Nilsson A, Sinkiewicz G. Decreased gum bleeding and reduced gingivitis by the probiotic Lactobacillus reuteri. Swed Dent J. 2006;30(2):55-60. PubMed 16878680 ↗
  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available. PubMed 5237684 ↗
  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available. PubMed 14158464 ↗
  • MacDonald KW, Chanyi RM, Macklaim JM, Cadieux PA, Reid G, Burton JP. Streptococcus salivarius inhibits immune activation by periodontal disease pathogens. BMC Oral Health. 2021 May 7;21(1):245. doi: 10.1186/s12903-021-01606-z. PubMed 33962608 ↗
  • Burton JP, Wescombe PA, Cadieux PA, Tagg JR. Beneficial microbes for the oral cavity: time to harness the oral streptococci? Benef Microbes. 2011 Jun;2(2):93-101. doi: 10.3920/BM2011.0002. PubMed 21840808 ↗
  • Meurman JH, Stamatova I. Probiotics: contributions to oral health. Oral Dis. 2007 Sep;13(5):443-51. doi: 10.1111/j.1601-0825.2007.01386.x. PubMed 17714346 ↗
  • Shah MP, Gujjari SK, Chandrasekhar VS. Evaluation of the effect of probiotic (inersan(R)) alone, combination of probiotic with doxycycline and doxycycline alone on aggressive periodontitis - a clinical and microbiological study. J Clin Diagn Res. 2013 Mar;7(3):595-600. doi: 10.7860/JCDR/2013/5225.2834. Epub 2013 Mar 1. PubMed 23634432 ↗
  • Iniesta M, Herrera D, Montero E, Zurbriggen M, Matos AR, Marin MJ, Sanchez-Beltran MC, Llama-Palacio A, Sanz M. Probiotic effects of orally administered Lactobacillus reuteri-containing tablets on the subgingival and salivary microbiota in patients with gingivitis. A randomized clinical trial. J Clin Periodontol. 2012 Aug;39(8):736-44. doi: 10.1111/j.1600-051X.2012.01914.x. Epub 2012 Jun 13. PubMed 22694350 ↗
  • Staab B, Eick S, Knofler G, Jentsch H. The influence of a probiotic milk drink on the development of gingivitis: a pilot study. J Clin Periodontol. 2009 Oct;36(10):850-6. doi: 10.1111/j.1600-051X.2009.01459.x. Epub 2009 Aug 12. PubMed 19682173 ↗
  • Maassen CB, van Holten-Neelen C, Balk F, den Bak-Glashouwer MJ, Leer RJ, Laman JD, Boersma WJ, Claassen E. Strain-dependent induction of cytokine profiles in the gut by orally administered Lactobacillus strains. Vaccine. 2000 May 22;18(23):2613-23. doi: 10.1016/s0264-410x(99)00378-3. PubMed 10775795 ↗
  • Salminen S, Benno Y, de Vos W. Intestinal colonisation, microbiota and future probiotics? Asia Pac J Clin Nutr. 2006;15(4):558-62. PubMed 17077076 ↗
  • Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10. PubMed 24912386 ↗
  • Teughels W, Van Essche M, Sliepen I, Quirynen M. Probiotics and oral healthcare. Periodontol 2000. 2008;48:111-47. doi: 10.1111/j.1600-0757.2008.00254.x. No abstract available. PubMed 18715361 ↗
  • Kapoor A, Malhotra R, Grover V, Grover D. Systemic antibiotic therapy in periodontics. Dent Res J (Isfahan). 2012 Sep;9(5):505-15. doi: 10.4103/1735-3327.104866. PubMed 23559912 ↗
  • Hanes PJ, Purvis JP. Local anti-infective therapy: pharmacological agents. A systematic review. Ann Periodontol. 2003 Dec;8(1):79-98. doi: 10.1902/annals.2003.8.1.79. PubMed 14971250 ↗
  • Quirynen M, Teughels W, De Soete M, van Steenberghe D. Topical antiseptics and antibiotics in the initial therapy of chronic adult periodontitis: microbiological aspects. Periodontol 2000. 2002;28:72-90. doi: 10.1034/j.1600-0757.2002.280104.x. No abstract available. PubMed 12013349 ↗
  • Yen CA, Damoulis PD, Stark PC, Hibberd PL, Singh M, Papas AS. The effect of a selective cyclooxygenase-2 inhibitor (celecoxib) on chronic periodontitis. J Periodontol. 2008 Jan;79(1):104-13. doi: 10.1902/jop.2008.070271. PubMed 18166099 ↗
  • Okada H, Murakami S. Cytokine expression in periodontal health and disease. Crit Rev Oral Biol Med. 1998;9(3):248-66. doi: 10.1177/10454411980090030101. PubMed 9715365 ↗
  • Haffajee AD, Socransky SS. Microbial etiological agents of destructive periodontal diseases. Periodontol 2000. 1994 Jun;5:78-111. doi: 10.1111/j.1600-0757.1994.tb00020.x. No abstract available. PubMed 9673164 ↗
  • Berezow AB, Darveau RP. Microbial shift and periodontitis. Periodontol 2000. 2011 Feb;55(1):36-47. doi: 10.1111/j.1600-0757.2010.00350.x. No abstract available. PubMed 21134227 ↗
  • Slots J. Periodontitis: facts, fallacies and the future. Periodontol 2000. 2017 Oct;75(1):7-23. doi: 10.1111/prd.12221. PubMed 28758294 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06871540
Lead sponsor
AYŞENUR ŞAHİN
Responsible party
AYŞENUR ŞAHİN (Research assistant, Inonu University) — Sponsor-investigator
First posted
Mar 12, 2025
Start date
Oct 1, 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Mar 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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