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Probiotic Use in Chronic Periodontitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403960
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Onur Ozcelik, Cukurova University

Brief Summary:

Aim: to evaluate the additional effects of the 12 weeks usage of a Streptococcus containing probiotic tablet after scaling and rootplaning compared to a placebo tablet.

Materials and methods: 48 periodontitis patients were included in this double-blind, placebo-controlled trial. After scaling and rootplaning, they were given patients used either a placebo (SRP) or probiotic tablet (SRP + P), 2 times a day for 12 weeks. Clinical and microbiological parameters were studied recorded up to 24 weeks after scaling and rootplaning.


Condition or disease Intervention/treatment Phase
Periodontitis Dietary Supplement: probiotic Dietary Supplement: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of a Streptococcus Probiotic in Periodontal Therapy: a Randomized Controlled Trial
Study Start Date : June 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Active Comparator: probiotic
The participants of the probiotic group were asked to let a probiotic tablet dissolve on their tongue 2 times a day for 3 months.
Dietary Supplement: probiotic
the patients used probiotic tablets in addition to scaling and root planning

Placebo Comparator: placebo
The participants of the control group were asked to let a placebo tablet dissolve on their tongue 2 times a day for 3 months.
Dietary Supplement: placebo
the patients used placebo tablets in addition to scaling and root planning




Primary Outcome Measures :
  1. probing pocket depth [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Recession [ Time Frame: 24 weeks ]
    Recession as measured in millimeters.

  2. clinical attachment level [ Time Frame: 24 weeks ]
    clinical attachment level as measured in millimeters

  3. Bleeding on probing [ Time Frame: 24 weeks ]
    Bleeding as measured in presence or absence of bleeding on probing the sulcus

  4. Gingival Index [ Time Frame: 24 weeks ]
  5. Plaque Index [ Time Frame: 24 weeks ]
  6. microbial counts of bacteria [ Time Frame: 24 weeks ]
    microbial counts as measured in colony forming units



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria were:

  1. healthy, non-institutionalized male or female patients,
  2. at least 35 years of age,
  3. a minimum of 3 natural teeth in every quadrant and
  4. previously untreated moderate to severe periodontitis

Exclusion Criteria:

Exclusion criteria were:

  1. received antibiotics for any purpose within 6 months prior to entering the study or suffering from a disease condition that would typically require antibiotic prophylaxis before dental treatment,
  2. a history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue (for example: phenytoin, cyclosporin, chronic use of non-steroidal anti-inflammatory drugs),
  3. pregnancy,
  4. acute oral lesions or necrotizing ulcerative periodontitis and
  5. dental personnel

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): NCT02403960


Locations
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Turkey
Cukurova University
Adana, Turkey, 01330
Sponsors and Collaborators
Cukurova University
Investigators
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Study Chair: Onur Ozcelik CU
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Onur Ozcelik, Professor, Cukurova University
ClinicalTrials.gov Identifier: NCT02403960    
Other Study ID Numbers: CukurovaU3
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases