On Probiotic, Dental Caries, and Orthodontic Patients

Not Applicable

• Conditions: Dental Caries
• Interventions: Dietary Supplement: Active Probiotic; Other: Placebo Probiotic

• Registration Number: NCT04593017
• Lead Sponsor: Göteborg University

Brief 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 ?

Detailed 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

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Study Start: 2020-11-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Probiotic	Active Probiotic	Probiotic contain active microorganism
Placebo Probiotic	Placebo Probiotic	Probiotic with no active microorganism

Primary Outcome Measures

Name	Time	Method
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Effect of Probiotics on Saliva	3 weeks	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?
Effect of Probiotics on Dental plaque	3 weeks	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.

Trial Locations

Locations (1)

Gothenburg university; 🇸🇪 Gothenburg, Sweden