Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

October 14, 2024 updated by: Damascus University

The Effectiveness of Probiotics on Oral Health During Adult Orthodontic Treatment With Fixed Appliances: A Two-arm Parallel-group Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20 HAJ72
        • Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics group
In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.
Drug: Probiotics
In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.
Active Comparator: 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.
Procedure: Traditional treatment
In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the plaque index
Time Frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months

Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for plaque index are as follows:

0. No plaque

  1. A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after the application of the disclosing solution or by using a probe on the tooth surface.
  2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.
  3. An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.
Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in the gingival index
Time Frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months

Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for the gingival index are as follows:

0. Normal gingiva.

  1. Mild inflammation: a slight change in color, slight edema, no bleeding on probing.
  2. Moderate inflammation: moderate glazing, redness, edema, hypertrophy, bleeding on probing.
  3. Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding.
Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in papillary bleeding index
Time Frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months

Assessment will be achieved using a gingival probe, according to Muhlemann (1977).

0. No bleeding.

  1. A single discreet bleeding point appears.
  2. Several isolated bleeding points or a single fine line of blood appear.
  3. The interdental triangle fills with blood shortly after probing.
  4. Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
The change in the probing depth
Time Frame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Assessment will be achieved using a gingival probe, according to Bowers (1964). It will be measured clinically as the distance from the free gingival margin to the gingival sulcus. The reading of PD ≤3 mm was considered normal, while any reading >3 mm was considered a gingival pocket
Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Lana Hasan Albardwel, DDS, Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2023

Primary Completion (Actual)

August 6, 2023

Study Completion (Actual)

June 17, 2024

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UDDS-Ortho-6-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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