Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

Study Overview
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Brief Summary
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The present study is a double-blinded randomized clinical trial with a duration of 28 days.

Detailed Description
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The present study is a double-blinded randomized clinical trial with a duration of 28 days. 80 orally and systemically healthy participant will be allocated in the test (probiotic) and the control (placebo) group at baseline. The intervention is oral hygiene discontinuation, which will be applied at baseline and continue through day 14, followed by 14 days with regular oral care. Clinical measurements and sampling will be performed at baseline, day 14 and day 28 Primary endpoint: Changes in microbial composition. Secondary endpoints: Changes in clinical and immunological parameters

Official Title
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Effect of Probiotics on Oral Homeostasis During Oral Hygiene Discontinuation

Conditions
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Gingivitis

Intervention / Treatment
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* Behavioral: Oral hygiene discontinuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - age > 18 yrs. Exclusion Criteria: Presence of oral diseases i.e. gingivitis, periodontitis and dental caries Current smokers Any systemic diseases and current use of any medication with known effect on oral health Use of systemic antibiotics within the latest three months Age < 18 yrs., and age > 30 yrs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomized clinical trial with a test and placebo group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>In this group participants will receive probiotic supplements twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). | Behavioral: Oral hygiene discontinuation<br>* Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care<br>|
| Placebo Comparator: Placebo<br>In this group participants will receiveplacebo twice a day (morning and evening) for at period of 28 days (14 days with oral hygiene discontinuation followed by 14 days with regular oral care). | Behavioral: Oral hygiene discontinuation<br>* Oral hygiene discontinuation for 14 days followed by 14 days of regular oral care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbial composition in dental | Changes in alpha and beta diversity of microbial composition | Baseline vs. Day 14 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in clinical parameters | Changes in levels of dental plaque and gingival inflammation | Baseline vs. Day 14 and Day 28 |