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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial

Conditions
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Enamel Hypomineralization, Dental

Intervention / Treatment
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* Combination Product: Curasept Biosmalto Mousse and toothpaste
* Other: Colgate toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>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<br>* at each visit a Curasept Biosmalto Mousse will be applied on the facial surface of the maxillary and mandibular anterior teeth using a tray.<br>|
| Placebo Comparator: control group<br>The control group will receive a fluoridated toothpaste (Colgate toothpaste) and instructed to brush at least three times/day. | Other: Colgate toothpaste<br>* The control group will receive a fluoridated toothpaste (Colgate toothpaste)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Slight WSLs extended or excessive WSLs 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 Outcome Measures

| Outcome Measure | 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 |