On Probiotic, Dental Caries, and Orthodontic Patients

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04593017
• Other study ID #: 260-20
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Caries

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