Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment

NCT04598633 | Unknown

• 1 other identifier: ER-Ortho-Pro-RCT-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus. Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment. Therefore, the aim of the study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation and prevent a dysbiosis of the oral microbiome.

Conditions

Gingivitis; Orthodontic Appliance Complication

Keywords

Orthodontics; Inflammation; Microbiome; Probiotics

Outcome Measures

Primary Outcomes (1)

• Gingival Index (GI)

  Primary endpoint is the change of the Gingival Index (GI) from baseline to week 4. The measurement of GI is described by Löe et al, which scores the gingival condition according to the defined criteria. The scores will be measured at four sites per tooth, added and divided by four to obtain the "GI for the tooth"-Index. We will use the 'GI for the tooth' described there, but only for those teeth with fixed ortodontic brackets. The 'GI for the patient' is then the mean of the GIs for the teeth. CRITERIA FOR THE GINGIVAL INDEX SYSTEM 0 = Absence of inflammation. 1. = Mild inflammation - slight cliange in color and little change in texture. 2. = Moderate inflammation - modcrate glazing, redness,oedema, hypertrophy, bleeding on pressure. 3. = Severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration.

  Baseline to week 4 of intake

Secondary Outcomes (4)

• Probing pocket depth (PPD) (4-point-measurement)

  Baseline till 12 months after insertion of appliance

• Modified Plaque Index (MPI)

  Baseline till 12 months after insertion of appliance

• Local cytokine expression

  Baseline till 12 months after insertion of appliance

• Oral microbiome

  Baseline till 12 months after insertion of appliance

Other Outcomes (1)

• Adverse events

  Baseline till 12 months after insertion of appliance.

Study Arms (2)

Lactobacillus reuteri Prodentis®-lozenges

ACTIVE COMPARATOR

Dietary Supplement: Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)

Placebo-lozenges (BioGaia)

PLACEBO COMPARATOR

Dietary Supplement: Placebo-lozenges (BioGaia)

Interventions

Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) DIETARY_SUPPLEMENT

Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks

Lactobacillus reuteri Prodentis®-lozenges

Placebo-lozenges (BioGaia) DIETARY_SUPPLEMENT

Placebo-lozenges (BioGaia) 2 times per day for 12 weeks

Placebo-lozenges (BioGaia)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents from age 12 to 17 with fixed appliances undergoing orthodontic treatment
• Signed declaration of consent by the patient and the parent or legal guardian for adolescent patients

You may not qualify if:

• Systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome
• obesity:
• adolescents: body mass index \> + 2 standard deviations (SD) over the average value given by the World Health Organisation (weight and height will be measured)
• Eating disorder or underweight
• adolescents: BMI \> -2 SD under the average value given by the WHO (weight and height will be measured)
• Above-average consumption of milk products: \> 3 portions/day = \>1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products)
• allergy to ingredients of the lozenges
• intake of antibiotics or dietary supplementation (probiotics, vitamin C/D) in the last 6 months or during the study
• regular use of antibacterial mouth wash
• pregnancy
• smoking
• retraction of the declaration of consent by the patient and the parent or legal guardian for adolescent patients

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• BioGaia AB: collaborator

Study Sites (1)

UniversityHospitalErlangen-Nurenberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (1)

• Seidel CL, Gerlach RG, Weider M, Wolfel T, Schwarz V, Strobel A, Schmetzer H, Bogdan C, Golz L. Influence of probiotics on the periodontium, the oral microbiota and the immune response during orthodontic treatment in adolescent and adult patients (ProMB Trial): study protocol for a prospective, double-blind, controlled, randomized clinical trial. BMC Oral Health. 2022 Apr 27;22(1):148. doi: 10.1186/s12903-022-02180-8.

  PMID: 35477563 DERIVED

MeSH Terms

Conditions

Gingivitis; Inflammation

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Corinna Lesley Seidel, Dr.

  Department of Orthodontics and Orofacial Orthopedics

  STUDY DIRECTOR

• Lina Gölz, Prof.Dr.

  Department of Orthodontics and Orofacial Orthopedics

  STUDY DIRECTOR

Central Study Contacts

Corinna Lesley Seidel, Dr.

CONTACT

++49-09131-85-45667; corinna.boeck@uk-erlangen.de

Lina Gölz, Prof.Dr.

CONTACT

++ 49 (0)9131 85-33643; lina.goelz@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study participants, meeting the inclusion criteria and not fulfilling the exclusion criteria, will be assigned to the study group or to the control group using a randomization plan. Randomization plan will be generated by the Center for Clincal Studies of the University Hospital of Erlangen. The lab manager will prepare storage boxes, in which exactly 168 lozenges will be stored. Half of the boxes will contain test-lozenges (study group), half or them will contain placebo-lozenges (control group). The storage boxes for the test and the placebo group will be identical and blinded. The storage boxes will be labelled with pseudonyms in accordance to the randomization plan generated by the Center for Clinical Studies. Therefore, study participants will not have knowledge of the group affiliation. The collection of the samples and the measuring of the clinical parameters will be performed by one orthodontist, who will be blinded to the randomization of the study participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontist

Model Details: Monocentric, randomized, double-blind, placebo-controlled, clinical study

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 22, 2020
• Study Start: November 24, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)