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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04593017
Other study ID # 260-20
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2020
Est. completion date December 21, 2020

Study information

Verified date October 2020
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 ?


Description:

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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 28
Est. completion date December 21, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Active Probiotic
Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659
Other:
Placebo Probiotic
Placebo

Locations

Country Name City State
Sweden Gothenburg university Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients. Changes in the plaque pH (acidic or alkaline) is an important factor among others in the cares process, in which an acidic environment will help the bacteria to accumulate along the tooth surface and starting the caries lesions.
So, considering the plaque pH as a clinical variable to show the probiotic effect is considered to be of great value.
3 weeks
Secondary Effect of Probiotics on Dental plaque Plaque is an important aspect in caries detection, so the change in the plaque sample will show if the probiotic will help in the caries prevention during orthodontic treatment. 3 weeks
Secondary Effect of Probiotics on Saliva The saliva composition which includes cariogenic bacteria (caries initiating bacteria) such as Streptococcus mutans and lactobacilli, is an important factor in caries detection, so saliva sample will show if the probiotic is helpful in caries prevention? 3 weeks
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