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The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients

Primary Purpose

White Spot Lesion

Status
Active
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Biogaia L. reuteri Prodentis® lozenges
Hersheyland Ice Breakers Mints sugar free lozenges
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for White Spot Lesion focused on measuring White spot lesions, Probiotic lozenges, QLF

Eligibility Criteria

17 Years - 33 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy patients from both sexes Having full fixed orthodontic appliances with expected remaining treatment duration of at least 6 months Optimum oral hygiene Maximum of 3 restored teeth Absence of defective enamel formation in the form of hypocalcification or hypoplasia Exclusion Criteria: Patients with poor oral hygiene Defective enamel Extensive restorations Gingival hyperplasia Salivary glands diseases Smoking, alcohol consumption, mouth wash use, antibiotic or probiotic intake in the last 3 months.

Sites / Locations

  • Postgraduate Dental Teaching Clinics/JUST

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Probiotic

Sugar free lozenges

Negative control

Arm Description

Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

Participants received Hersheyland Ice Breakers Mints sugar free lozenges

Participants received no lozenges or supplements

Outcomes

Primary Outcome Measures

Incidence of white spot lesions (WSL)
Number of newly developed white spot lesions
Lesion area
Surface area of the WSL (in pixels)
ΔF%
Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.

Secondary Outcome Measures

ΔFMax (%)
Deepest point in the lesion
ΔR30 (%)
Amount of plaque present

Full Information

First Posted
February 4, 2023
Last Updated
February 21, 2023
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05738369
Brief Title
The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients
Official Title
The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients: Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment.
Detailed Description
Background: Recently, the use of probiotics has emerged as a treatment for prevention of oral cavity diseases including periodontal problems, and initial caries. The objectives of this prospective randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment. Methods: Quantitative light induced fluorescence (QLF) images were taken for three randomly allocated groups (intervention group, n=23; positive control, n=23; negative control, n=24) of patients undergoing orthodontic treatment in three separate occasions (T0: before the start of study; T1: at 6 weeks later; T2: at 3 months after the commencement of the study). Subjects in the intervention group were instructed to take one probiotic lozenge containing two strains of Lactobacillus reuteri twice daily. Sugar-free lozenges were used in the positive control group and no lozenges for the negative control group. The QLF images were analyzed using a dedicated software in order to quantitatively analyze each tooth. The primary outcomes measured were the number of newly developed lesions in each group, lesion area and amount of mineral loss (ΔF). Means and standard deviations were calculated using the Statistical Package for the Social Science (SPSS version 28, Chicago, IL, USA). Split plot ANOVA (SPANOVA) test for repeated measures was used to check differences within and between the three groups regarding lesion area and ΔF. To check which group is different from the others, Tukey's test was used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion
Keywords
White spot lesions, Probiotic lozenges, QLF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three arm parallel design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The investigated supplements were provided to the participants by a research assistant. The participants in the negative control group, however, were not blinded because they did not receive any supplements
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Participants received treatment with Biogaia L. reuteri Prodentis® lozenges
Arm Title
Sugar free lozenges
Arm Type
Placebo Comparator
Arm Description
Participants received Hersheyland Ice Breakers Mints sugar free lozenges
Arm Title
Negative control
Arm Type
No Intervention
Arm Description
Participants received no lozenges or supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Biogaia L. reuteri Prodentis® lozenges
Intervention Description
Participants were instructed to use the lozenges twice daily after brushing their teeth; once in the morning and once in the evening
Intervention Type
Dietary Supplement
Intervention Name(s)
Hersheyland Ice Breakers Mints sugar free lozenges
Intervention Description
Hersheyland Ice Breakers Mints sugar free lozenges
Primary Outcome Measure Information:
Title
Incidence of white spot lesions (WSL)
Description
Number of newly developed white spot lesions
Time Frame
3 months
Title
Lesion area
Description
Surface area of the WSL (in pixels)
Time Frame
3 months
Title
ΔF%
Description
Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ΔFMax (%)
Description
Deepest point in the lesion
Time Frame
3 months
Title
ΔR30 (%)
Description
Amount of plaque present
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy patients from both sexes Having full fixed orthodontic appliances with expected remaining treatment duration of at least 6 months Optimum oral hygiene Maximum of 3 restored teeth Absence of defective enamel formation in the form of hypocalcification or hypoplasia Exclusion Criteria: Patients with poor oral hygiene Defective enamel Extensive restorations Gingival hyperplasia Salivary glands diseases Smoking, alcohol consumption, mouth wash use, antibiotic or probiotic intake in the last 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Al-Khateeb
Organizational Affiliation
Faculty of Dentistry/Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Dental Teaching Clinics/JUST
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon request
Citations:
PubMed Identifier
6758594
Citation
Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.
Results Reference
background
PubMed Identifier
15591733
Citation
Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
Results Reference
background
Citation
3. Øgaard, B. White spot lesions during orthodontic treatment: mechanisms and fluoride preventive aspects. Semin Orthod. 2008; 14: 183-193). WB Saunders.
Results Reference
background
PubMed Identifier
14685020
Citation
van Loveren C, Duggal MS. Experts' opinions on the role of diet in caries prevention. Caries Res. 2004;38 Suppl 1:16-23. doi: 10.1159/000074358.
Results Reference
background
PubMed Identifier
14972061
Citation
Moynihan P, Petersen PE. Diet, nutrition and the prevention of dental diseases. Public Health Nutr. 2004 Feb;7(1A):201-26. doi: 10.1079/phn2003589.
Results Reference
background
PubMed Identifier
25878972
Citation
Anusha RL, Umar D, Basheer B, Baroudi K. The magic of magic bugs in oral cavity: Probiotics. J Adv Pharm Technol Res. 2015 Apr-Jun;6(2):43-7. doi: 10.4103/2231-4040.154526.
Results Reference
background
Citation
7. FAO/WHO. Evaluation of health and nutritional properties of powder milk and live lactic acid bacteria. Food and Agriculture Organization of the United Nations and World Health Organization Expert Consultation Report. 2001; 1-34.
Results Reference
background
PubMed Identifier
20173706
Citation
Flichy-Fernandez AJ, Alegre-Domingo T, Penarrocha-Oltra D, Penarrocha-Diago M. Probiotic treatment in the oral cavity: an update. Med Oral Patol Oral Cir Bucal. 2010 Sep 1;15(5):e677-80. doi: 10.4317/medoral.15.e677.
Results Reference
background
PubMed Identifier
16597207
Citation
Doron S, Gorbach SL. Probiotics: their role in the treatment and prevention of disease. Expert Rev Anti Infect Ther. 2006 Apr;4(2):261-75. doi: 10.1586/14787210.4.2.261.
Results Reference
background
PubMed Identifier
23810047
Citation
Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.
Results Reference
background
PubMed Identifier
29352461
Citation
Galofre M, Palao D, Vicario M, Nart J, Violant D. Clinical and microbiological evaluation of the effect of Lactobacillus reuteri in the treatment of mucositis and peri-implantitis: A triple-blind randomized clinical trial. J Periodontal Res. 2018 Jun;53(3):378-390. doi: 10.1111/jre.12523. Epub 2018 Jan 19.
Results Reference
background
PubMed Identifier
23222326
Citation
Guerrieri A, Gaucher C, Bonte E, Lasfargues JJ. Minimal intervention dentistry: part 4. Detection and diagnosis of initial caries lesions. Br Dent J. 2012 Dec;213(11):551-7. doi: 10.1038/sj.bdj.2012.1087.
Results Reference
background
PubMed Identifier
9118184
Citation
Ando M, Hall AF, Eckert GJ, Schemehorn BR, Analoui M, Stookey GK. Relative ability of laser fluorescence techniques to quantitate early mineral loss in vitro. Caries Res. 1997;31(2):125-31. doi: 10.1159/000262387.
Results Reference
background
PubMed Identifier
9637561
Citation
Al-Khateeb S, Forsberg CM, de Josselin de Jong E, Angmar-Mansson B. A longitudinal laser fluorescence study of white spot lesions in orthodontic patients. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):595-602. doi: 10.1016/s0889-5406(98)70218-5.
Results Reference
background
PubMed Identifier
12199119
Citation
Pretty IA, Hall AF, Smith PW, Edgar WM, Higham SM. The intra- and inter-examiner reliability of quantitative light-induced fluorescence (QLF) analyses. Br Dent J. 2002 Jul 27;193(2):105-9. doi: 10.1038/sj.bdj.4801496.
Results Reference
background
PubMed Identifier
11961326
Citation
Al-Khateeb S, Exterkate RA, de Josselin de Jong E, Angmar-Mansson B, ten Cate JM. Light-induced fluorescence studies on dehydration of incipient enamel lesions. Caries Res. 2002 Jan-Feb;36(1):25-30. doi: 10.1159/000057586.
Results Reference
background
PubMed Identifier
14158464
Citation
SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
Results Reference
background
PubMed Identifier
5237684
Citation
Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
Results Reference
background
PubMed Identifier
32354432
Citation
Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.
Results Reference
background
Citation
20. Dahlberg, G. Statistical methods for medical and biological students. Statistical Methods for Medical and Biological Students. 1940
Results Reference
background
PubMed Identifier
6573846
Citation
Houston WJ. The analysis of errors in orthodontic measurements. Am J Orthod. 1983 May;83(5):382-90. doi: 10.1016/0002-9416(83)90322-6.
Results Reference
background
PubMed Identifier
16211161
Citation
Moynihan PJ. The role of diet and nutrition in the etiology and prevention of oral diseases. Bull World Health Organ. 2005 Sep;83(9):694-9. Epub 2005 Sep 30.
Results Reference
background
PubMed Identifier
22765388
Citation
Manfred L, Covell DA, Crowe JJ, Tufekci E, Mitchell JC. A novel biomimetic orthodontic bonding agent helps prevent white spot lesions adjacent to brackets. Angle Orthod. 2013 Jan;83(1):97-103. doi: 10.2319/110811-689.1. Epub 2012 Jun 27.
Results Reference
background
PubMed Identifier
25840585
Citation
Gizani S, Petsi G, Twetman S, Caroni C, Makou M, Papagianoulis L. Effect of the probiotic bacterium Lactobacillus reuteri on white spot lesion development in orthodontic patients. Eur J Orthod. 2016 Feb;38(1):85-89. doi: 10.1093/ejo/cjv015. Epub 2015 Apr 3.
Results Reference
background
PubMed Identifier
23289733
Citation
Julien KC, Buschang PH, Campbell PM. Prevalence of white spot lesion formation during orthodontic treatment. Angle Orthod. 2013 Jul;83(4):641-7. doi: 10.2319/071712-584.1. Epub 2013 Jan 4.
Results Reference
background
PubMed Identifier
11794561
Citation
van Loveren C, Duggal MS. The role of diet in caries prevention. Int Dent J. 2001;51(6 Suppl 1):399-406. doi: 10.1111/j.1875-595x.2001.tb00586.x.
Results Reference
background
PubMed Identifier
18595200
Citation
Stookey GK. The effect of saliva on dental caries. J Am Dent Assoc. 2008 May;139 Suppl:11S-17S. doi: 10.14219/jada.archive.2008.0347.
Results Reference
background
PubMed Identifier
24889893
Citation
Keller MK, Nohr Larsen I, Karlsson I, Twetman S. Effect of tablets containing probiotic bacteria (Lactobacillus reuteri) on early caries lesions in adolescents: a pilot study. Benef Microbes. 2014 Dec;5(4):403-7. doi: 10.3920/BM2013.0089.
Results Reference
background
Citation
Talaat, D. Effect of Probiotic Chewable Tablets on Oral Health and White Spot Lesions in Pre-school Children: A Randomized Clinical Trial. Egypt Dent J. 2021; 67: 1797-1807.
Results Reference
background
PubMed Identifier
25712760
Citation
Flichy-Fernandez AJ, Ata-Ali J, Alegre-Domingo T, Candel-Marti E, Ata-Ali F, Palacio JR, Penarrocha-Diago M. The effect of orally administered probiotic Lactobacillus reuteri-containing tablets in peri-implant mucositis: a double-blind randomized controlled trial. J Periodontal Res. 2015 Dec;50(6):775-85. doi: 10.1111/jre.12264. Epub 2015 Feb 25.
Results Reference
background

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The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients

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