Evaluation of Dental and Periodontal Health After IPR in Patients in Orthodontic Treatment With Clear Aligners

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-100
SponsorUniversity of Campania Luigi Vanvitelli

About this trial

This study aimed to evaluate dental and periodontal health after interproximal enamel reduction and to compare Laser diode (a device used in the Orthodontic Program) and sodium fluoride (often used in the Orthodontic Program and in the Material Dental Program). The hypothesis was that the intervention groups would show a lower dentin hypersensitivity incidence than the control group during orthodontic treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

to be in orthodontic treatment with clear aligners and this treatment requires interproximal enamel reduction;

permanent dentition;

good oral and periodontal health.

Disqualifiers

enamel defects;

cervical caries;

periodontal disease;

history of trauma or craniofacial anomalies;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Evaluation of Dentin hypersensitivity with VAS scale

    Diagnostic test

    Dentin hypersensitivity and periodontal indices evaluation are performed after and before IPR, at 1 week, 1 month and 3 months

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Control GroupExperimental treatment 1 intervention
Group B: Laser Diode GroupExperimental treatment 1 intervention
Group C: Sodium Fluoride GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assestment of DH after IPR

Dentin hypersensitivity will be assessed before and after interproximal enamel reduction and after the application of therapeutic protocols. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

Time frame
from 3 to 4 months
2

Reduction of the Dentin Hypersensitivity

. Dentin hypersensitivity will be performed with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli.

Time frame
from 3 to 4 months

Secondary outcomes

1

Evaluation of Dentin hypersensitivity after the application of therapeutic protocols.

Evaluate Dentin Hypersensitivity in the control group and the treated groups,with the evaporative method. After isolation of the adjacent teeth, the air syringe will be placed 2-3 mm from the tooth surface, at a perpendicular position of 90º, and a continuous air blast of 45 to 60 psi (3.10 to 4.13 Bar) should be applied for 2-3 seconds. The air temperature should be around 20°C (19-22°C). The discomfort will be expressed in a numerical 0-10 cm visual analog scale (VAS) where the value 0 is correlated with no discomfort and the value 10 for utmost discomfort or intolerable pain during application of the stimulus. Each patient will place a vertical mark on the VAS to indicate the intensity of his or her level of sensitivity after the applied stimuli. To assess in which group it reduces or is eliminated more quickly.

Time frame
from 3 to 4 months

Other outcomes

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