Clinical trial NCT02546206: Probiotic Yoghurt Effect on Experimental Gingivitis
Official title: Influence of Probiotics on Clinical Parameters and GCF Levels of Interleukin-1β in Experimental Gingivitis: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gingivitis
Keywords: Bifidobacterium
Gingivitis
Gingival crevicular fluid
Interleukin-1beta
Probiotics
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Probiotics are viable bacteria with scientifically confirmed health benefits for gastrointestinal system. However, there is paucity of information on its impact in periodontal disease. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bleeding on probing
timeFrame: 33 days after yoghurt consumption
Secondary outcomes:
measure: Gingival Index
timeFrame: 33 days after yoghurt consumption
measure: Plaque Index
timeFrame: 33 days after yoghurt consumption
Other outcomes:
measure: Probing Depth
timeFrame: 33 days after yoghurt consumption
measure: Gingival crevicular fluid Interleukin-1beta levels
timeFrame: 33 days after yoghurt consumption
Locations:
city: Istanbul
country: Turkey
facility: Marmara University, Faculty of Dentistry, Department of Periodontology
state: Sisli/Nisantasi
Study officials:
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Tuğçe Yalnızoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Bahar Kuru, Prof Dr
role: STUDY_DIRECTOR
References: