On Probiotic, Dental Caries, and Orthodontic Patients

Göteborg University

Status: Unknown

Conditions: Dental Caries

Treatments: Other: Placebo Probiotic; Dietary Supplement: Active Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT04593017

260-20

Details and patient eligibility

About

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 ?

Full 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

Enrollment: 28 patients

Sex: All

Ages: 14 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Active Probiotic

Experimental group

Description:

Probiotic contain active microorganism

Treatment:

Dietary Supplement: Active Probiotic

Placebo Probiotic

Placebo Comparator group

Description:

Probiotic with no active microorganism

Treatment:

Other: Placebo Probiotic