Clinical trial NCT05940701: The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Orthodontic Treatment
Official title: The Effectiveness of Biomimetic Materials in Preventing Enamel Demineralization During Fixed Appliance Orthodontic Treatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enamel Hypomineralization, Dental
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: WSLs evaluation
timeFrame: 6 month
Secondary outcomes:
measure: amount of plaque and gingival bleeding
timeFrame: 6 month
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Samar Husam Assim Alkhdhairi
Study officials:
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