Clinical and Microbiological Aspects of Probiotics in Non-surgical Periodontal Therapy.

NCT06063226 | Unknown

• 1 other identifier: PARO
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to test the effect orally administration of Probiotics based on Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14 as adjuvant in people suffering from periodontitis stage II-III. The main questions it aims to answer are:

• QUESTION 1: orally administered probiotics based on the previous strains could represent a useful tool in support of non-surgical periodontal therapy in reducing clinical periodontal indexes?
• QUESTION 2: orally administered probiotics based on the previous strains could represent a useful tool in support of non-surgical periodontal therapy in reduce the amount of periodontal pathogens in periodontal pockets? Partecipants in the test group will take the test probiotic for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the positive controlled group will take the placebo for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the negative control group will perform only the routinary oral hygiene procedures. Researchers will compare 3 groups to see if orally administered probiotics based on L. rhamnosus and L. plantarum may hel in the reduction of periodontal indexes and of the periodontal pathogen bacteria.

Conditions

Periodontitis; Probiotics; Non Surgical Periodontal Therapy

Keywords

lactobacillus rhamnosus; lactobacillus plantarum; supportive periodontal therapy; non surgical periodontal therapy

Outcome Measures

Primary Outcomes (1)

• Reduction of clinical periodontal indexes

  Evaluation of clinical periodontal indexes, such as: bleeding on probing (BOP), periodontal pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), total number of pathological sites in %.

  From enrollement to the end of treatment at 3 months.

Secondary Outcomes (1)

• Reduction of periodontal pathogen bacteria amount.

  From enrollement to the end of treatment at 3 months.

Study Arms (3)

Probiotics

EXPERIMENTAL

Patients who will be assigned to oral consumption of one stick of probiotics with L. plantarum and L. rhamnosus for 30 days, in adjucntion to routinary oral hygiene procedures.

Other: Experimental

Positive Control

PLACEBO COMPARATOR

Patients who will be assigned to oral consumption of one stick of placebo for 30 days, in adjucntion to routinary oral hygiene procedures.

Other: Positive control

Negative control

OTHER

Patients who will be assigned to routinary oral hygiene procedures esclusively.

Other: Negative control

Interventions

Experimental OTHER

Orally administred probiotics with L. plantarum and L. rhamnosus

Also known as: Orally administration of probiotics with L. plantarum and L. rhamnosus

Probiotics

Negative control OTHER

Only routinary oral hygiene procedures

Also known as: Only routinary oral hygiene procedures

Negative control

Positive control OTHER

Orally administred placebo without probiotics

Also known as: Orally administred placebo without probiotics

Positive Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the absence of other systemic pathologies reported in the medical history
• smokers and non-smokers, non-drinkers,
• subjects in the absence of previous or current administration of other sources of probiotics,
• subjects capable of providing informed consent.

You may not qualify if:

• Subjects with a history of systemic diseases (diabetes, autoimmune diseases, inflammatory bowel diseases, neurodegenerative diseases),
• drinkers,
• subjects who take or have taken probiotics in the last 3 months,
• subjects unable to provide informed consent.

Sponsors & Collaborators

• G. d'Annunzio University: lead
• Probiotical S.p.A.: collaborator

Study Sites (1)

University G. d'Annunzio

Chieti, 66100, Italy

Location

Related Publications (17)

• Iwasaki K, Maeda K, Hidaka K, Nemoto K, Hirose Y, Deguchi S. Daily Intake of Heat-killed Lactobacillus plantarum L-137 Decreases the Probing Depth in Patients Undergoing Supportive Periodontal Therapy. Oral Health Prev Dent. 2016;14(3):207-14. doi: 10.3290/j.ohpd.a36099.

  PMID: 27175447 BACKGROUND

• Sulijaya B, Takahashi N, Yamazaki K. Lactobacillus-Derived Bioactive Metabolites for the Regulation of Periodontal Health: Evidences to Clinical Setting. Molecules. 2020 Apr 29;25(9):2088. doi: 10.3390/molecules25092088.

  PMID: 32365716 BACKGROUND

• Etebarian A, Sheshpari T, Kabir K, Sadeghi H, Moradi A, Hafedi A. Oral Lactobacillus species and their probiotic capabilities in patients with periodontitis and periodontally healthy individuals. Clin Exp Dent Res. 2023 Oct;9(5):746-756. doi: 10.1002/cre2.740. Epub 2023 Apr 20.

  PMID: 37078410 BACKGROUND

• Pudgar P, Povsic K, Cuk K, Seme K, Petelin M, Gaspersic R. Probiotic strains of Lactobacillus brevis and Lactobacillus plantarum as adjunct to non-surgical periodontal therapy: 3-month results of a randomized controlled clinical trial. Clin Oral Investig. 2021 Mar;25(3):1411-1422. doi: 10.1007/s00784-020-03449-4. Epub 2020 Jul 14.

  PMID: 32666349 BACKGROUND

• Mendi A, Kose S, Uckan D, Akca G, Yilmaz D, Aral L, Gultekin SE, Eroglu T, Kilic E, Uckan S. Lactobacillus rhamnosus could inhibit Porphyromonas gingivalis derived CXCL8 attenuation. J Appl Oral Sci. 2016 Jan-Feb;24(1):67-75. doi: 10.1590/1678-775720150145.

  PMID: 27008259 BACKGROUND

• Gatej SM, Marino V, Bright R, Fitzsimmons TR, Gully N, Zilm P, Gibson RJ, Edwards S, Bartold PM. Probiotic Lactobacillus rhamnosus GG prevents alveolar bone loss in a mouse model of experimental periodontitis. J Clin Periodontol. 2018 Feb;45(2):204-212. doi: 10.1111/jcpe.12838. Epub 2017 Dec 11.

  PMID: 29121411 BACKGROUND

• 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.

  PMID: 26944407 BACKGROUND

• Fu J, Jia L, Wu L, Jiang Y, Zhao R, Du J, Guo L, Zhang C, Xu J, Liu Y. Lactobacillus rhamnosus inhibits osteoclast differentiation by suppressing the TLR2/NF-kappaB pathway. Oral Dis. 2024 May;30(4):2373-2386. doi: 10.1111/odi.14712. Epub 2023 Aug 21.

  PMID: 37602540 BACKGROUND

• Routier A, Blaizot A, Agossa K, Dubar M. What do we know about the mechanisms of action of probiotics on factors involved in the pathogenesis of periodontitis? A scoping review of in vitro studies. Arch Oral Biol. 2021 Sep;129:105196. doi: 10.1016/j.archoralbio.2021.105196. Epub 2021 Jun 10.

  PMID: 34153538 BACKGROUND

• Nguyen T, Brody H, Radaic A, Kapila Y. Probiotics for periodontal health-Current molecular findings. Periodontol 2000. 2021 Oct;87(1):254-267. doi: 10.1111/prd.12382.

  PMID: 34463979 BACKGROUND

• Morales A, Gandolfo A, Bravo J, Carvajal P, Silva N, Godoy C, Garcia-Sesnich J, Hoare A, Diaz P, Gamonal J. Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170075. doi: 10.1590/1678-7757-2017-0075.

  PMID: 29364340 BACKGROUND

• 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.

  PMID: 24164569 BACKGROUND

• Furlaneto F, Ishikawa KH, Messora MR, Mayer MPA. Probiotics During the Therapeutic Management of Periodontitis. Adv Exp Med Biol. 2022;1373:353-375. doi: 10.1007/978-3-030-96881-6_19.

  PMID: 35612808 BACKGROUND

• Gruner D, Paris S, Schwendicke F. Probiotics for managing caries and periodontitis: Systematic review and meta-analysis. J Dent. 2016 May;48:16-25. doi: 10.1016/j.jdent.2016.03.002. Epub 2016 Mar 8.

  PMID: 26965080 BACKGROUND

• Lee Y, Yoon Y, Choi KH. Probiotics-Mediated Bioconversion and Periodontitis. Food Sci Anim Resour. 2021 Nov;41(6):905-922. doi: 10.5851/kosfa.2021.e57. Epub 2021 Nov 1.

  PMID: 34796320 BACKGROUND

• Bustamante M, Oomah BD, Mosi-Roa Y, Rubilar M, Burgos-Diaz C. Probiotics as an Adjunct Therapy for the Treatment of Halitosis, Dental Caries and Periodontitis. Probiotics Antimicrob Proteins. 2020 Jun;12(2):325-334. doi: 10.1007/s12602-019-9521-4.

  PMID: 30729452 BACKGROUND

• Sanz M, Ceriello A, Buysschaert M, Chapple I, Demmer RT, Graziani F, Herrera D, Jepsen S, Lione L, Madianos P, Mathur M, Montanya E, Shapira L, Tonetti M, Vegh D. Scientific evidence on the links between periodontal diseases and diabetes: Consensus report and guidelines of the joint workshop on periodontal diseases and diabetes by the International diabetes Federation and the European Federation of Periodontology. Diabetes Res Clin Pract. 2018 Mar;137:231-241. doi: 10.1016/j.diabres.2017.12.001. Epub 2017 Dec 5.

  PMID: 29208508 BACKGROUND

Related Links

• New Classification of periodontal and peri-implant diseases

MeSH Terms

Conditions

Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marco Dolci, MD DDS PHD

  University G. d'Annunzio of Chieti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Dolci, MD DDS PHD

CONTACT

+393281665925; marco.dolci@unich.it

Silvia D'Agostino, DDS PHD

CONTACT

+393930246351; silvia.dagostino@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)