On Probiotic, Dental Caries, and Orthodontic Patients

Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients

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 ?

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Dietary supplement: Active Probiotic; Other: Placebo Probiotic

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-405 30
    • Gothenburg university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Probiotic; Probiotic contain active microorganism	Dietary supplement: Active Probiotic; Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659
Placebo Comparator: Placebo Probiotic; Probiotic with no active microorganism	Other: Placebo Probiotic; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Göteborg University

Publications and helpful links

General Publications

• Alforaidi S, Bresin A, Almosa N, Lehrkinder A, Lingström P. Effect of drops containing Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) on plaque acidogenicity and other caries-related variables in orthodontic patients. BMC Microbiol. 2021 Oct 6;21(1):271. doi: 10.1186/s12866-021-02310-2.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 21, 2020

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 260-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This research planned for publication
• IPD Sharing Time Frame: As soon as we finish with the data collection and the manuscript writing, the data will be published online.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No