Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

NCT06641960 | Completed DMC

• 1 other identifier: UDDS-Ortho-6-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (4)

• The change in the plaque index

  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

  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

  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

  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

Study Arms (2)

Probiotics group

EXPERIMENTAL

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

Drug: Probiotics

The control group without Probiotics

ACTIVE COMPARATOR

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

Procedure: Traditional treatment

Interventions

Probiotics DRUG

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

Probiotics group

Traditional treatment PROCEDURE

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

The control group without Probiotics

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult healthy male and female patients aged 18-25 years.
• Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.
• Patients with malocclusion class I, II, or III without crowding on the anterior teeth.
• Permanent occlusion and existence of all the upper and lower teeth (except third molars).
• Good oral and periodontal health:
• Probing depth \< 4 mm
• No radiographic evidence of bone loss.
• Gingival index ≤ 1
• Plaque index ≤ 1

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

Location

Related Publications (5)

• Cerroni S, Pasquantonio G, Condo R, Cerroni L. Orthodontic Fixed Appliance and Periodontal Status: An Updated Systematic Review. Open Dent J. 2018 Sep 28;12:614-622. doi: 10.2174/1745017901814010614. eCollection 2018.

  PMID: 30369970 BACKGROUND

• Contaldo M, Lucchese A, Lajolo C, Rupe C, Di Stasio D, Romano A, Petruzzi M, Serpico R. The Oral Microbiota Changes in Orthodontic Patients and Effects on Oral Health: An Overview. J Clin Med. 2021 Feb 16;10(4):780. doi: 10.3390/jcm10040780.

  PMID: 33669186 BACKGROUND

• Agossa K, Dubar M, Lemaire G, Blaizot A, Catteau C, Bocquet E, Nawrocki L, Boyer E, Meuric V, Siepmann F. Effect of Lactobacillus reuteri on Gingival Inflammation and Composition of the Oral Microbiota in Patients Undergoing Treatment with Fixed Orthodontic Appliances: Study Protocol of a Randomized Control Trial. Pathogens. 2022 Jan 18;11(2):112. doi: 10.3390/pathogens11020112.

  PMID: 35215057 BACKGROUND

• Freitas AO, Marquezan M, Nojima Mda C, Alviano DS, Maia LC. The influence of orthodontic fixed appliances on the oral microbiota: a systematic review. Dental Press J Orthod. 2014 Mar-Apr;19(2):46-55. doi: 10.1590/2176-9451.19.2.046-055.oar.

  PMID: 24945514 BACKGROUND

• Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.

  PMID: 36137992 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Lana Hasan Albardwel, DDS

  Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: March 5, 2023
• Primary Completion: August 6, 2023
• Study Completion: June 17, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)