Probiotic Yoghurt Effect on Experimental Gingivitis
Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
1 other identifier
interventional
51
1 country
1
Brief Summary
The aim of this study was to evaluate the effects of probiotic yoghurt on the development of gingival inflammation. Fifty-one periodontally healthy individuals were given standard oral hygiene instructions and randomly divided into two groups. The test group subjects (n=26) consumed probiotic yoghurt containing Bifidobacterium animalis subsp. lactis and the control subjects (n=25) natural yoghurt for 28 days. Following yoghurt consumption, mechanical plaque control was interrupted for the next 5 days in both groups. Gingival crevicular fluid (GCF) samples and clinical data (consisted of plaque and gingival indices, probing depth, bleeding on probing) were collected at baseline, after 28 and 33 days. Interleukin-1β levels were determined in GCF by ELISA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Nov 2011
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 30, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedSeptember 10, 2015
August 1, 2015
6 months
August 30, 2015
September 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding on probing
Bleeding on probing is defined as presence of bleeding from gingival sulcus during the probing of this area via periodontal probe.
33 days after yoghurt consumption
Secondary Outcomes (2)
Gingival Index
33 days after yoghurt consumption
Plaque Index
33 days after yoghurt consumption
Other Outcomes (2)
Probing Depth
33 days after yoghurt consumption
Gingival crevicular fluid Interleukin-1beta levels
33 days after yoghurt consumption
Study Arms (2)
Probiotic Yoghurt
EXPERIMENTALProbiotic yoghurt consumption
Natural Yoghurt
PLACEBO COMPARATORNatural yoghurt consumption
Interventions
Eligibility Criteria
You may qualify if:
- No or minimal clinical signs of gingival inflammation
- Gingival Index ≤ 1
- No probing depth (Probing depth \> 3 mm)
- No approximal attachment loss \> 2 mm
- Non smokers
You may not qualify if:
- Systemic diseases
- Antibiotics and anti-inflammatory drugs within 3 months before the study
- Untreated caries lesions or local retention factors
- Mouth-breathing
- Allergies
- Previous probiotic supplements in diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University, Faculty of Dentistry, Department of Periodontology
Istanbul, Sisli/Nisantasi, 34365, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuğçe Yalnızoğlu, PhD
Marmara University, Faculty of Dentistry, Department of Periodontology
- STUDY DIRECTOR
Bahar Kuru, Prof Dr
Marmara University, Faculty of Dentistry, Department of Periodontology
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2015
First Posted
September 10, 2015
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 10, 2015
Record last verified: 2015-08