Laser Therapy and Flouride Therapy in Desensibilization Hypomineralized Teeth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-12-23

Brief Summary

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To investigate the efficacy of laser therapy associated with fluorotherapy in the desensibitization of hypomineralized teeth in children 8 to 12 years of age. A randomized blinded clinical trial will be conducted. The instruments used will be a questionnaire general, clinical examination, dental air syringe (evaluation of dental sensitivity) and visual analogue scale (evaluation of the magnitude of dental sensitivity). Teeth with hypomineralization molar-incisor (HMI) and the results of sensitivity and magnitude of dental pain before and after the treatments will be recorded in a clinical record. The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).

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Detailed Description

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A blinded randomized clinical trial will be conducted. The study will be conducted with children attending the Pediatric Dentistry Clinic of the Florence Institute's undergraduate course, in São Luís, Maranhão, Brazil. As inclusion criteria, children from 8 to 12 years of age will be adopted, with at least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity and presenting sensitive hypomineralization lesions. Exclusion criteria will be children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis, teeth with loss of structure dental and carious lesions, children in orthodontic treatment, children with cognition problems, children who used any type of analgesic / anti-inflammatory medication before treatment, children undergoing desensitizing treatment in the last 3 months, children with behavioral problems and children with occlusal problems such as tightening and bruxism.

The instruments of data collection will be a general questionnaire (demographic, socioeconomic and etiological factors for HMI), clinical examination for diagnosis of HMI, dental sensitivity test with air syringe and visual analogue scale (to assess the magnitude of pain). In a clinical file will be recorded the teeth with HMI, the result of the sensitivity test and magnitude of dental pain before and after treatments. The general questionnaire will be answered by the parents / guardians. In cases of incomplete questionnaires, parents / guardians will be contacted by telephone.

The diagnosis of HMI will be performed according to the criteria proposed by the European Academy of Child Dentistry (WEERHEIJM et al., 2003). The researcher will be calibrated for the application of the questionnaire and for the diagnosis of HMI lesions.

The study groups will be: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3). For the treatment of group 1, the low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site. The treatment of Group 2 will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions. Group 3 will be treated first with the laser (same specifications as Group 1), followed by application of fluoride varnish (same specifications as Group 2).

Conditions

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Hypomineralization Molar Incisor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Groups: treatment with laser therapy (Group 1); treatment with fluorotherapy (Group 2) and treatment with laser therapy and fluorotherapy (Group 3).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The researcher who will evaluate the treatments through the syringe test will be masked as to the type of treatment performed in each patient. The investigator responsible for the treatment and the patient will not be masked.

Study Groups

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Laser therapy

The low-power, infrared (808nm wavelength) diode laser with a power of 100mW (Therapy EC, DMC) will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site.

Group Type EXPERIMENTAL

Laser therapy

Intervention Type RADIATION

The low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site.

Fluorotherapy

The treatment will be carried out with the application of fluoride varnish (Duraphat), with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions.

Group Type ACTIVE_COMPARATOR

Fluorotherapy

Intervention Type PROCEDURE

The treatment will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions.

Laser therapy and fluorotherapy

The teeth will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).

Group Type EXPERIMENTAL

Laser therapy and Fluorotherapy

Intervention Type COMBINATION_PRODUCT

This group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).

Interventions

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Laser therapy

The low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site.

Intervention Type RADIATION

Fluorotherapy

The treatment will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions.

Intervention Type PROCEDURE

Laser therapy and Fluorotherapy

This group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Children from 8 to 12 years of age;
* At least one first permanent or incisive erupted incisor (with occlusal / incisal surface free of gingiva) present in the oral cavity;
* Teeth presenting hypomineralization lesions sensitive.

Exclusion Criteria

* Children with enamel malformations linked to syndromes, with dental fluorosis, enamel hypoplasia or with imperfect amelogenesis;
* Teeth with loss of dental structure and carious lesion;
* Children in orthodontic treatment;
* Children with cognition problems;
* Children who used any type of analgesic / anti-inflammatory medication before treatment;
* Children undergoing desensitizing treatment in the last 3 months
* Children with behavioral problems;
* Children with occlusal problems such as tightening and bruxism.

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes