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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics group | Experimental | 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 | Active Comparator | In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Drug | In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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.
| 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.
| 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lana Hasan Albardwel, DDS | Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthodontics, Faculty of Dentistry, University of Damsacus | Damascus | DM20 HAJ72 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30369970 | Background | 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. | |
| 33669186 | 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. |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Traditional treatment | Procedure | In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges. |
|
| Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months |
| 35215057 | 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. |
| 24945514 | 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. |
| 36137992 | 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. |
| D019602 |
| Food and Beverages |