NCT04593017

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 ?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 5, 2020

Last Update Submit

October 13, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effect of Probiotics on Dental plaque

    3 weeks

  • Effect of Probiotics on Saliva

    3 weeks

Study Arms (2)

Active Probiotic

EXPERIMENTAL

Probiotic contain active microorganism

Dietary Supplement: Active Probiotic

Placebo Probiotic

PLACEBO COMPARATOR

Probiotic with no active microorganism

Other: Placebo Probiotic

Interventions

Active ProbioticDIETARY_SUPPLEMENT

Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659

Active Probiotic
Placebo ProbioticOTHER

Placebo

Placebo Probiotic

Eligibility Criteria

Age14 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth Male and Female matched in age and gender
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects undergoing bimaxillary fixed orthodontic treatment
  • Number of S. mutans counts (\>10.000 CFU/ml)
  • Permanent dentition
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gothenburg university

Gothenburg, SE-405 30, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34615458DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
3rd party will be involved in labeling the test and placebo samples
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two groups matched in age and gender
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 19, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 21, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

This research planned for publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
As soon as we finish with the data collection and the manuscript writing, the data will be published online.

Locations

SE(1)