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Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH

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ClinicalTrials.gov Identifier: NCT03614819
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Luciana Pion Antonio, University of Sao Paulo

Brief Summary:
Background: Nowadays an increase in the incidence of teeth affected by molar incisor hypomineralisation (MIH) has been observed. There are several treatment modalities that depend on the degree of severity of the defect, such as preventive procedures, restorative and even dental extractions. However, these changes may affect the retention and longevity of restorative materials. Therefore, the aim of this study is to evaluate the use of diode laser irradiation for the treatment of occlusal surfaces of moderate lesions in permanent first molars affected with MIH as a preventive method for dental caries and occlusal wear, besides verifying the discomfort of the treatment by patients. Methods: For this, a controlled and randomized study, with parallel groups, will be conducted comparing the treatment with diode laser and sealing with high viscosity glass ionomer cement in the teeth affected by the MIH. Participants will be assessed at baseline and after 1 week, 1, 6, 12, 18 and 24 months. As the main outcome, the presence of dentin caries lesion and /or occlusal surface wear included in the study with dentin involvement will be evaluated. A visual examination for caries detection will be done using the ICDAS, using the index based on classification in the United States Public Health Service - Modified (USPH) for evaluation of sealed teeth and impression of impacted teeth for quantitative analysis of the lesions. Other outcomes such as patient satisfaction with treatment, patient discomfort, impact on quality of life and participant perception, as well as the duration and cost of treatment, as well as their cost-efficacy, will also be evaluated. Multilevel statistical analyzes will be performed to verify the efficacy of Diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.

Condition or disease Intervention/treatment Phase
Dental Enamel Hypoplasia Procedure: Diode laser group Procedure: Glass Ionomer Sealing Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Diode laser group Prophylaxis of the selected region for the study and application of diode laser (Sirolaser, Sirona Dental Systems GmbH, Bensheim, Germany) with wavelength of 970 nm +/- 10 nm, maximum power of 7 W CW, 1mW guide beam and 320μm optical fiber. Irradiation will be performed on the entire occlusal surface in contact mode, with power of 0.7 W and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2.

Glass Ionomer Sealing Group Prophylaxis of the selected region for the study, followed by relative insulation with cotton rollers of the tooth in question, application of acid polyacrylic for 15 seconds throughout the surface, light drying with cotton ball, insertion of the high viscosity glass ionomer (Equia Forte in capsule - GC) through a specific applicator, after loss of the gloss of the digital pressure material with Vaseline for due drainage and surface protection of the material.

Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Prevention
Official Title: Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Diode laser group
Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying, followed by application of diode laser (Sirolaser, Sirona Dental Systems GmbH, Bensheim, Germany) with wavelength of 970 nm +/- 10 nm, maximum power of 7 W CW, 1mW guide beam and 320μm optical fiber. Irradiation will be performed on the entire occlusal surface in contact mode, with power of 0.7 W (energy of 70 mJ) and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2. The FieldMaxII-TOP power meter (Coherent, Inc, USA) will be used prior to and after the applications. The laser will be applied in a sweeping motion throughout the affected surface, the fiber being maintained positioned perpendicular to the occlusal surface throughout the movement. The irradiation time will be standardized in 30 seconds.
Procedure: Diode laser group
Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying, followed by application of diode laser (Sirolaser, Sirona Dental Systems GmbH, Bensheim, Germany) with wavelength of 970 nm +/- 10 nm, maximum power of 7 W CW, 1mW guide beam and 320μm optical fiber. Irradiation will be performed on the entire occlusal surface in contact mode, with power of 0.7 W (energy of 70 mJ) and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2. The FieldMaxII-TOP power meter (Coherent, Inc, USA) will be used prior to and after the applications. The laser will be applied in a sweeping motion throughout the affected surface, the fiber being maintained positioned perpendicular to the occlusal surface throughout the movement. The irradiation time will be standardized in 30 seconds.

Active Comparator: Glass Ionomer Sealing Group
Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying with cotton balls, followed by relative insulation with cotton rollers of the tooth in question, application of acid polyacrylic for 15 seconds throughout the surface, light drying with cotton ball, insertion of the high viscosity glass ionomer (Equia Forte in capsule - GC) through a specific applicator, after loss of the gloss of the digital pressure material with Vaseline for due drainage and surface protection of the material, removal of the excess, checking the occlusion with carbon paper, occlusal adjustments if necessary, superficial protection with petroleum jelly.
Procedure: Glass Ionomer Sealing Group
Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying with cotton balls, followed by relative insulation with cotton rollers of the tooth in question, application of acid polyacrylic for 15 seconds throughout the surface, light drying with cotton ball, insertion of the high viscosity glass ionomer (Equia Forte in capsule - GC) through a specific applicator, after loss of the gloss of the digital pressure material with Vaseline for due drainage and surface protection of the material, removal of the excess, checking the occlusion with carbon paper, occlusal adjustments if necessary, superficial protection with petroleum jelly.




Primary Outcome Measures :
  1. Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up [ Time Frame: All surfaces will be examined after previous cleaning with prophylactic paste and water and a Robson brush, with lighting and after air drying and 1, 6, 12, 18 and 24 months after ]
    The main outcome will be the presence of changes in clinical signs in relation to the progression of carious lesions and / or occlusal surface wear included in the study with dentin involvement through ICDAS, photographs, radiographic examination and the index based on the classification in the United States Public Health Service - Modified (USPH).


Secondary Outcome Measures :
  1. Satisfaction in relation the treatment using VAS scale [ Time Frame: This evaluation will be applied after 1 week of treatment, 1, 12 and 24 months and will not be identified by name and will be done in the absence of the operators so as not to restrain the subject from expressing their actual opinion. ]
    The responsibles will be asked to respond about the satisfaction regarding the care (treatment and follow-up) received by their children. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst evaluation of treatment and 10 being the best.

  2. Self-reported discomfort using Wong Backer face scale after the treatment [ Time Frame: This evaluation will be performed before starting the treatment with laser or with high viscosity glass ionomer and 2 minutes after the treatment is performed] ]
    In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces that the first one is very smiling and the expressions are changing, until the last one is very sad. The face 1 mean "no hurts", face 2 "hurts little bit", face 3 "hurts little more", face 4 "hurts even more", face 5 "hurts whole lot", face 6 "hurts worst". The child chooses the face that judges more similar to his own after the treatment.

  3. Hypersensitivity to dentin [ Time Frame: This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion ]
    The patients will answer to a VAS scale with indexes from 0 to 10 (no pain - 0 and worst pain - 10) for each teeth.

  4. Evaluation of patient's perception of satisfaction regarding their oral health [ Time Frame: For this, an external examiner will apply the questionnaire prior to randomization and on 1, 12 and 24 month return visits. ]

    The evaluation of the patient's perception of satisfaction regarding his / her oral health will be performed through the questionnaire of quality of life, Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years old.

    The questionnaire consists of 10 questions. Each question is composed of 5 answers: a) Never, b) Once or twice, c) Sometimes, d) Often, e) Every day or almost every day. These issues include generic and specific aspects of oral diseases. For example: "In the last month, how many times have you had toothache or mouth pain?" or "In the last month, how many times have you felt sad because of your teeth or your mouth?"


  5. Costs of each consultation performed through study completion [ Time Frame: The time spent in each of the sessions will be timed by an external examiner not participating in the exams, who will also note the number of visits of each participant. The data will be collected at all return visits (1 week, 1, 6, 12, 18 and 24 months) ]
    To calculate the direct costs of the procedures, the time spent in each consultation (initials and reevaluations) will be taken into account. For the calculation of direct costs, the prices of consumer and permanent materials (specifications and quantity) used in each procedure, electricity and the professional fee will be considered.



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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children who present at the first permanent molar with occlusal surface affected with light or moderate severity of MIH
  • Children between 6 and 10 years old

Exclusion Criteria:

  • Teeth that present restorations
  • Teeth that presente sealants
  • Enamel malformations that are specific to some syndromes
  • Hypomineralized enamel affected by the ingestion of fluoride during enamel development

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614819


Contacts
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Contact: LUCIANA PION ANTONIO +5511999092090 lucianapion@hotmail.com
Contact: REGINA GUENKA PALMA-DIBB +5516981274976 rgpalma@gmail.com

Locations
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Brazil
Luciana Pion Antonio Recruiting
Ribeirão Preto, SP, Brazil, 14040-904
Contact: LUCIANA P ANTONIO    11999092090    lucianapion@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo
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Responsible Party: Luciana Pion Antonio, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03614819    
Other Study ID Numbers: MIHForp
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Luciana Pion Antonio, University of Sao Paulo:
Lasers
Dental enamel hypoplasia
Preventive dentistry
Dental caries
Additional relevant MeSH terms:
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Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities