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This study will be done to evaluate the impact of Biosmalto Impact Action Mousseâ„¢ on the development and healing of WSLs in individuals receiving orthodontic treatment.
The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day.
This study is a multicenter randomized clinical trial with blinded parallel groups, simple randomization, an equal allocation ratio (1:1), and no stratification.The patients will be initially assessed for eligibility to be included in the study by the investigator.The study was verbally explained to those who fulfilled the inclusion criteria in order to get their first consent for participation. After that, they received the patient information sheet (Appendix), which explained the purpose of the research. The patients were instructed to thoroughly read the informational material at home and tell the researcher of their intention to participate at the next visit. Participants had to either sign the consent form (which was attached to the patient information sheet) or get their parents' permission (if the participant was under the age of 18 years). The investigator provided the patients with further information or reassurance about the trial if needed.
All the participants received a standardized treatment protocol. The patients were treated with straight wire appliance using metal brackets (3BOrtho, China). Initially, teeth polishing was performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique was performed using 37% phosphoric acid for 30 seconds (Heinig and Hartmann, 2008b), then washed with water for 15-20 seconds, and dried for 10 seconds. A thin coat of primer was applied to the etched surfaces by an applicator and cured for 15 seconds by the LED light-curing unit. The brackets were bonded using similar adhesive (3B Ortho, white glue, China) and checked so that no obvious extra adhesive is remained on the tooth surface around the brackets. The control group received a fluoridated toothpaste (Colgate toothpaste). The intervention group received Curasept toothpaste and additionally at each visit a Curasept Biosmalto Mousse was applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.
For each patient recruited, identical toothbrushes and oral care instructions were given. The patients received instructions to brush their teeth for at least two minutes using an up-down motion on their anterior teeth and a circular motion on their posterior teeth at least three times/day. Additionally, the patients were instructed not to use any additional antimicrobial-containing products (mouthwash, toothpaste, gel).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | The intervention group will receive Curasept toothpaste with instructions and additionally at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. |
|
| control group | Placebo Comparator | The control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curasept Biosmalto Mousse and toothpaste | Combination Product | at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray. |
| Measure | Description | Time Frame |
|---|---|---|
| WSLs evaluation | To evaluate the number of WSLs on the labial surfaces of maxillary and mandibular anterior teeth using enamel white spot lesion index (WSLI), ICDAS (International caries detection and assessment system) and DIAGNOdent pen scores at each visit and after six months during orthodontic treatment. Gorelick Index : 0: no WSLs
DIAGNOdent pen reading: 0 - 10 Healthy Tooth Structure 11-20 Outer Half Enamel Caries 21-30 Inner Half Enamel Caries 30+ Dentin Caries | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| amount of plaque and gingival bleeding | To evaluate the amount of plaque and gingival bleeding by using visible plaque index (VPI) gingival bleeding index (GBI) at each visit (4-6 weeks) Visible plaque index (VPI) 0: non-visible plaque 1: visible plaque Gingival bleeding index (GBI) 0: no gingival bleeding 1: gingival bleeding | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samar Husam Assim Alkhdhairi | Baghdad | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17977295 | Background | Andersson A, Skold-Larsson K, Hallgren A, Petersson LG, Twetman S. Effect of a dental cream containing amorphous cream phosphate complexes on white spot lesion regression assessed by laser fluorescence. Oral Health Prev Dent. 2007;5(3):229-33. | |
| 17823680 | Background | Ardu S, Castioni NV, Benbachir N, Krejci I. Minimally invasive treatment of white spot enamel lesions. Quintessence Int. 2007 Sep;38(8):633-6. |
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| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| ID | Term |
|---|---|
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Colgate toothpaste | Other | The control group will receive a fluoridated toothpaste (Colgate toothpaste) |
|
| 15591733 | Background | 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. |
| 30957083 | Background | Cosma LL, Suhani RD, Mesaros A, Badea ME. Current treatment modalities of orthodontically induced white spot lesions and their outcome - a literature review. Med Pharm Rep. 2019 Jan;92(1):25-30. doi: 10.15386/cjmed-1090. Epub 2019 Jan 15. |
| 22718979 | Background | Du J, Yuan Y, Si T, Lian J, Zhao H. Customized optimization of metabolic pathways by combinatorial transcriptional engineering. Nucleic Acids Res. 2012 Oct;40(18):e142. doi: 10.1093/nar/gks549. Epub 2012 Jun 19. |
| 19897823 | Background | Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. |
| 32051965 | Background | Gizani S, Kloukos D, Papadimitriou A, Roumani T, Twetman S. Is Bleaching Effective in Managing Post-orthodontic White-spot Lesions? A Systematic Review. Oral Health Prev Dent. 2020 Feb 14;18(1):2-10. doi: 10.3290/j.ohpd.a44113. |
| 6758594 | Background | 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. |
| 30451901 | Background | Iafisco M, Degli Esposti L, Ramirez-Rodriguez GB, Carella F, Gomez-Morales J, Ionescu AC, Brambilla E, Tampieri A, Delgado-Lopez JM. Fluoride-doped amorphous calcium phosphate nanoparticles as a promising biomimetic material for dental remineralization. Sci Rep. 2018 Nov 19;8(1):17016. doi: 10.1038/s41598-018-35258-x. |
| 27030284 | Background | Sonesson M, Bergstrand F, Gizani S, Twetman S. Management of post-orthodontic white spot lesions: an updated systematic review. Eur J Orthod. 2017 Apr 1;39(2):116-121. doi: 10.1093/ejo/cjw023. |
| 21208070 | Background | Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1. |
| 40657473 | Derived | Assim SH, Yassir YA. Effect of biomimetic tooth mousse and toothpaste on the incidence of white spot lesions during fixed appliance orthodontic treatment: A randomized clinical trial. J Taibah Univ Med Sci. 2025 Jun 25;20(3):405-416. doi: 10.1016/j.jtumed.2025.06.004. eCollection 2025 Jun. |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |