The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Orthodontic Treatment

NCT05940701 | Unknown

• 1 other identifier: 763423
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be done to evaluate the impact of Biosmalto Impact Action Mousse™ 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.

Conditions

Enamel Hypomineralization, Dental

Outcome Measures

Primary Outcomes (1)

• 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 1. Slight WSLs 2. extended or excessive WSLs 3. WSLs with cavitation 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

Secondary Outcomes (1)

• amount of plaque and gingival bleeding

  6 month

Study Arms (2)

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.

Combination Product: Curasept Biosmalto Mousse and toothpaste

control group

PLACEBO COMPARATOR

The control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day.

Other: Colgate toothpaste

Interventions

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.

intervention group

Colgate toothpaste OTHER

The control group will receive a fluoridated toothpaste (Colgate toothpaste)

control group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to participate.
• No underlying medical conditions requiring medications that may cause dryness of the mouth.
• Fully erupted permanent maxillary and mandibular canines and incisors that have not been restored.

You may not qualify if:

• Receiving professional fluoridation within the last three months.
• Untreated cavitated lesions or significant restorations on the facial surfaces of study teeth.
• Labial restoration of any of the study teeth.
• Missing any of the study teeth.
• Severely rotated any of the study teeth (limiting the appearance of buccal surfaces).
• Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation.
• Dental anomalies related to morphology, anatomy, or development.
• Pregnancy and xerostomia.
• Heavy smokers.
• Craniofacial syndromes such as clefts

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Samar Husam Assim Alkhdhairi

Baghdad, Iraq

Location

Related Publications (12)

• 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.

  PMID: 17977295 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.

  PMID: 17823680 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.

  PMID: 15591733 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.

  PMID: 30957083 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.

  PMID: 22718979 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.

  PMID: 19897823 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.

  PMID: 32051965 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.

  PMID: 6758594 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.

  PMID: 30451901 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.

  PMID: 27030284 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.

  PMID: 21208070 BACKGROUND

• 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.

  PMID: 40657473 DERIVED

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Interventions

Toothpastes

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontics master student

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 11, 2023
• Study Start: January 15, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)