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Efficacy of Oral Probiotic Administration in Patients With Chronic Periodontitis (probiotic)

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ClinicalTrials.gov Identifier: NCT02283736
Recruitment Status : Unknown
Verified June 2016 by Jorge Gamonal, University of Chile.
Recruitment status was:  Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Gamonal, University of Chile

Brief Summary:

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Thirty six chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3 and 6 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The tablets will be used once per day during 3 months.


Condition or disease Intervention/treatment Phase
-Chronic Periodontitis Other: Lactobacillus rhamnosus SP1 Other: Talc powder Procedure: Periodontal treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Probiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment.
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one tablet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Other: Lactobacillus rhamnosus SP1
Tablet containing Lactobacillus rhamnosus SP1

Procedure: Periodontal treatment
Scaling and root planning

Placebo Comparator: Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Other: Talc powder
Tablet containing talc powder

Procedure: Periodontal treatment
Scaling and root planning




Primary Outcome Measures :
  1. Differences of at least 1mm between groups for clinical attachment level changes [ Time Frame: baseline, 3, 6 months ]

Secondary Outcome Measures :
  1. Differences between groups for probing depth changes [ Time Frame: baseline, 3, 6 month ]
  2. Differences between groups for bleeding on probing changes [ Time Frame: baseline, 3, 6 months ]
  3. Differences between groups for plaque index changes [ Time Frame: baseline, 3, 6 months ]
  4. Differences between groups for levels of Interleukin (IL)-17, IL-21, Transforming Growth Factor (TGF)- beta, IL-10, RANKL changes in gingival crevicular fluid [ Time Frame: baseline, 3, 6 months ]
  5. Differences between groups for levels of periodontal pathogens changes [ Time Frame: baseline, 3, 6 months ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥14 natural teeth, excluding third molars
  • ≥10 posterior teeth
  • ≥35 years old
  • ≥ 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm
  • Bleeding on probing ≥20% of sites
  • Extensive bone loss determined radiographically

Exclusion Criteria:

  • Periodontal treatment before the time of examination
  • Systemic illness
  • Pregnancy
  • Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283736


Locations
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Chile
Faculty of Dentistry of University of Chile
Santiago, Chile
Sponsors and Collaborators
Jorge Gamonal
Investigators
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Principal Investigator: Jorge Gamonal, Professor Faculty of Dentistry of University of Chile

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Responsible Party: Jorge Gamonal, Professor, University of Chile
ClinicalTrials.gov Identifier: NCT02283736     History of Changes
Other Study ID Numbers: FONDECYT 1130570
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Keywords provided by Jorge Gamonal, University of Chile:
Chronic periodontitis
Probiotics
Non- surgical treatment
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases