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CompletedNCT05738369Updated Apr 9, 2026

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

An interventional study of Biogaia L. reuteri Prodentis® lozenges and Hersheyland Ice Breakers Mints sugar free lozenges in White Spot Lesion, sponsored by Jordan University of Science and Technology. Completed at 1 site in Jordan. Open to participants aged 17 Years to 33 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
17 Years to 33 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • White Spot Lesion

Keywords

  • White spot lesions, Probiotic lozenges, QLF
03

In context

Lead sponsor

Jordan University of Science and Technology is the lead sponsor of 88 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 33 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Probiotic

    Participants received treatment with Biogaia L. reuteri Prodentis® lozenges

    Dietary Supplement: Biogaia L. reuteri Prodentis® lozenges

  • Placebo comparator
    Sugar free lozenges

    Participants received Hersheyland Ice Breakers Mints sugar free lozenges

    Dietary Supplement: Hersheyland Ice Breakers Mints sugar free lozenges

  • No intervention
    Negative control

    Participants received no lozenges or supplements

Interventions

  • Dietary supplementBiogaia L. reuteri Prodentis® lozenges

    Participants were instructed to use the lozenges twice daily after brushing their teeth; once in the morning and once in the evening

  • Dietary supplementHersheyland Ice Breakers Mints sugar free lozenges

    Hersheyland Ice Breakers Mints sugar free lozenges

06

What researchers measure

Primary outcomes

  1. Incidence of white spot lesions (WSL)

    Number of newly developed white spot lesions

    Time frame: 3 months

  2. Lesion area

    Surface area of the WSL (in pixels)

    Time frame: 3 months

  3. ΔF%

    Average lesion fluorescence loss (ΔF%) reflecting mineral loss in percent.

    Time frame: 3 months

Secondary outcomes

  1. ΔFMax (%)

    Deepest point in the lesion

    Time frame: 3 months

  2. ΔR30 (%)

    Amount of plaque present

    Time frame: 3 months

07

Study locations

1 site
  • Postgraduate Dental Teaching Clinics/JUST
    Irbid, 22110, Jordan
08

References and documents

Publications

  • 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. PubMed 6758594 ↗
  • 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. PubMed 15591733 ↗
  • 3. Øgaard, B. White spot lesions during orthodontic treatment: mechanisms and fluoride preventive aspects. Semin Orthod. 2008; 14: 183-193). WB Saunders.
  • 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. PubMed 14685020 ↗
  • 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. PubMed 14972061 ↗
  • 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. PubMed 25878972 ↗
  • 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.
  • 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. PubMed 20173706 ↗
  • 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. PubMed 16597207 ↗
  • 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. PubMed 23810047 ↗
  • 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. PubMed 29352461 ↗
  • 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. PubMed 23222326 ↗
  • 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. PubMed 9118184 ↗
  • 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. PubMed 9637561 ↗
  • 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. PubMed 12199119 ↗
  • 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. PubMed 11961326 ↗
  • 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. PubMed 14158464 ↗
  • 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. PubMed 5237684 ↗
  • 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. PubMed 32354432 ↗
  • 20. Dahlberg, G. Statistical methods for medical and biological students. Statistical Methods for Medical and Biological Students. 1940
  • 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. PubMed 6573846 ↗
  • 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. PubMed 16211161 ↗
  • 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. PubMed 22765388 ↗
  • 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. PubMed 25840585 ↗
  • 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. PubMed 23289733 ↗
  • 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. PubMed 11794561 ↗
  • 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. PubMed 18595200 ↗
  • 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. PubMed 24889893 ↗
  • 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.
  • 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. PubMed 25712760 ↗

Individual participant data

Plan to share: No — Data will be available upon request

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738369
Lead sponsor
Jordan University of Science and Technology
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
Feb 14, 2022
Primary completion
Jul 1, 2022
Completion
Dec 1, 2022
Last update
Apr 9, 2026

Study contacts

Susan Al-Khateeb
principal investigator · Faculty of Dentistry/Jordan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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