On Probiotic, Dental Caries, and Orthodontic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2020-12-21

Brief Summary

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To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?

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Detailed Description

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To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.

The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.

This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups matched in age and gender

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

3rd party will be involved in labeling the test and placebo samples

Study Groups

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Active Probiotic

Probiotic contain active microorganism

Group Type EXPERIMENTAL

Active Probiotic

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659

Placebo Probiotic

Probiotic with no active microorganism

Group Type PLACEBO_COMPARATOR

Placebo Probiotic

Intervention Type OTHER

Placebo

Interventions

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Active Probiotic

Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659

Intervention Type DIETARY_SUPPLEMENT

Placebo Probiotic

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing bimaxillary fixed orthodontic treatment
* Number of S. mutans counts (\>10.000 CFU/ml)
* Permanent dentition
* 3-12 months into the treatment (study from Sweden by Andrea)
* Medically healthy
* Not taking any medication
* Ability to understand the nature of the study and sign the consent form

Exclusion Criteria

* Cleft lip and palate patients as well as handicapped and patients with mental impairments
* Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
* History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
* Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
* Habitual consumers of xylitol chewing gums
* No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste

Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes