Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641960
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Probiotics on Oral Health During Adult Orthodontic Treatment With Fixed Appliances A Two-arm Parallel-group Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group In each group they will brush their teeth regularly while receiving orthodontic treatment Only the probiotic group will take probiotic tablets for six months
Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment
Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment
Detailed Description:
Each subject will be examined completely to ensure eligibility before enrolling in the study The operator will then inform them about the studys aim and ask them to provide written informed consent Patients will receive professional scaling polishing and oral hygiene instruction before the research starts
Regarding the probiotic PRODENTIS is commercially available in Sweden and the USA Probiotics prepared by Bio-Gaia AB Stockholm Sweden Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin L reuteri DSM 17938 and L reuteri ATCC PTA 5289 each at a minimum of 1 108 CFU per lozenge The tablets should be stored at a temperature below 25 C Dosage instructions will be prescribed per the manufacturers recommendations at a preventive dosage of 1 lozengeday after dinner and teeth brushing
Regarding the clinical parameters the Plaque index Pl the gingival index GI the Papillary Bleeding Index PBI 1977 and probing depth PD will be evaluated
Regarding the probiotic PRODENTIS is commercially available in Sweden and the USA Probiotics prepared by Bio-Gaia AB Stockholm Sweden Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin L reuteri DSM 17938 and L reuteri ATCC PTA 5289 each at a minimum of 1 108 CFU per lozenge The tablets should be stored at a temperature below 25 C Dosage instructions will be prescribed per the manufacturers recommendations at a preventive dosage of 1 lozengeday after dinner and teeth brushing
Regarding the clinical parameters the Plaque index Pl the gingival index GI the Papillary Bleeding Index PBI 1977 and probing depth PD will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None