Probiotic Use in Chronic Periodontitis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02403960
• Date of registration: 16/03/2015
• Prospective Registration: No
• Primary sponsor: Cukurova University
• Public title: Probiotic Use in Chronic Periodontitis Patients
• Scientific title: The Effect of a Streptococcus Probiotic in Periodontal Therapy: a Randomized Controlled Trial
• Date of first enrolment: June 2010
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02403960
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Onur Ozcelik
• Affiliation: CU

Key inclusion & exclusion 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



Age minimum: 35 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontitis

Intervention(s)

Dietary Supplement: probiotic

Dietary Supplement: placebo

Primary Outcome(s)

probing pocket depth [Time Frame: 24 weeks]

Secondary Outcome(s)

microbial counts of bacteria [Time Frame: 24 weeks]

Recession [Time Frame: 24 weeks]

clinical attachment level [Time Frame: 24 weeks]

Plaque Index [Time Frame: 24 weeks]

Bleeding on probing [Time Frame: 24 weeks]

Gingival Index [Time Frame: 24 weeks]

Secondary ID(s)

CukurovaU3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors