Clinical trial NCT06641960: Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment
Official title: The Effectiveness of Probiotics on Oral Health During Adult Orthodontic Treatment With Fixed Appliances: A Two-arm Parallel-group Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in the plaque index
timeFrame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
measure: The change in the gingival index
timeFrame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
measure: The change in papillary bleeding index
timeFrame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
measure: The change in the probing depth
timeFrame: Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, University of Damascus, Damascus , Syria
name: Lana Hasan Albardwel, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.