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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05738369
Other study ID # JUST20220097
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 14, 2022
Est. completion date May 2023

Study information

Verified date February 2023
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 75
Est. completion date May 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 33 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Biogaia 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
Hersheyland Ice Breakers Mints sugar free lozenges
Hersheyland Ice Breakers Mints sugar free lozenges

Locations

Country Name City State
Jordan Postgraduate Dental Teaching Clinics/JUST Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (30)

20. Dahlberg, G. Statistical methods for medical and biological students. Statistical Methods for Medical and Biological Students. 1940

3. Øgaard, B. White spot lesions during orthodontic treatment: mechanisms and fluoride preventive aspects. Semin Orthod. 2008; 14: 183-193). WB Saunders.

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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of white spot lesions (WSL) Number of newly developed white spot lesions 3 months
Primary Lesion area Surface area of the WSL (in pixels) 3 months
Primary ?F% Average lesion fluorescence loss (?F%) reflecting mineral loss in percent. 3 months
Secondary ?FMax (%) Deepest point in the lesion 3 months
Secondary ?R30 (%) Amount of plaque present 3 months
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