Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-05

Study Completion Date

2024-06-17

Brief Summary

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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.

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Detailed Description

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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

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Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Probiotics group

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.

Group Type EXPERIMENTAL

Probiotics

Intervention Type DRUG

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.

The control group without Probiotics

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

Group Type ACTIVE_COMPARATOR

Traditional treatment

Intervention Type PROCEDURE

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

Interventions

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Probiotics

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.

Intervention Type DRUG

Traditional treatment

In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult healthy male and female patients aged 18-25 years.
2. Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
3. Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
4. Permanent occlusion and existence of all the upper and lower teeth (except third molars).
5. Good oral and periodontal health:

* Probing depth \< 4 mm
* No radiographic evidence of bone loss.
* Gingival index ≤ 1
* Plaque index ≤ 1

Exclusion Criteria

1. Previous orthodontic treatment history.
2. Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
3. Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
4. Patients who were allergic to ingredients of the probiotics lozenges.
5. Those undergoing periodontal treatment within three months before the baseline examination.
6. Smokers, pregnant or lactating women.
7. Regular use of antibacterial mouthwash.

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No