NCT06641960

Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each subject will be examined completely to ensure eligibility before enrolling in the study. The operator will then inform them about the study's 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 manufacturer's recommendations at a preventive dosage of 1 lozenge/day (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.

Conditions

• Orthodontic Appliance Complication

Interventions

Type	Name	Description
DRUG	Probiotics	In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.
PROCEDURE	Traditional treatment	In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

Timeline

• Start date: 2023-03-05
• Primary completion: 2023-08-06
• Completion: 2024-06-17
• First posted: 2024-10-15
• Last updated: 2024-10-16

Locations

1 site across 1 country: Syria