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On Probiotic, Dental Caries, and Orthodontic Patients

Primary Purpose

Dental Caries

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Active Probiotic

Placebo Probiotic

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

14 Years - 30 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

Gothenburg university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Probiotic

Placebo Probiotic

Arm Description

Probiotic contain active microorganism

Probiotic with no active microorganism

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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?

Full Information

NCT ID

NCT04593017

First Posted

October 5, 2020

Last Updated

October 13, 2020

Sponsor

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT04593017

Brief Title

On Probiotic, Dental Caries, and Orthodontic Patients

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Anticipated)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

December 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two groups matched in age and gender

Masking

ParticipantInvestigator

Masking Description

3rd party will be involved in labeling the test and placebo samples

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Probiotic

Arm Type

Experimental

Arm Description

Probiotic contain active microorganism

Arm Title

Placebo Probiotic

Arm Type

Placebo Comparator

Arm Description

Probiotic with no active microorganism

Intervention Type

Dietary Supplement

Intervention Name(s)

Active Probiotic

Intervention Description

Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659

Intervention Type

Other

Intervention Name(s)

Placebo Probiotic

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.

Description

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Effect of Probiotics on Dental plaque

Description

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.

Time Frame

3 weeks

Title

Effect of Probiotics on Saliva

Description

Time Frame

3 weeks

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Both Male and Female matched in age and gender

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Gothenburg university

City

Gothenburg

ZIP/Postal Code

SE-405 30

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

34615458

Citation

Alforaidi S, Bresin A, Almosa N, Lehrkinder A, Lingstrom 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.

Results Reference

derived

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On Probiotic, Dental Caries, and Orthodontic Patients

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