Dental Enamel HypoplasiaNCT03614819
Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH
A study testing Diode laser group and Glass Ionomer Sealing Group in people with Dental Enamel Hypoplasia, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Enamel Hypoplasia
- What is being tested?
- Diode laser group and Glass Ionomer Sealing Group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2018to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study
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.
- Conditions
- Dental Enamel Hypoplasia
- Being tested
- Diode laser group, Glass Ionomer Sealing Group
- Keywords
- Lasers, Dental enamel hypoplasia, Preventive dentistry, Dental caries
- Medical subject headings
- Dental Enamel Hypoplasia, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laser groupProcedure or surgery
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.
Glass Ionomer Sealing GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diode laser group | Experimental | 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. Receives: Procedure: Diode laser group |
| Glass Ionomer Sealing Group | Active comparator | 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. Receives: Procedure: Glass Ionomer Sealing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical signs change in the progression of caries lesion and / or occlusal surface wear during the follow-up
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).
Measured: 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
Secondary outcomes (5)
Satisfaction in relation the treatment using VAS scale
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.
Measured: 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.
Self-reported discomfort using Wong Backer face scale after the treatment
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.
Measured: 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]
Hypersensitivity to dentin
The patients will answer to a VAS scale with indexes from 0 to 10 (no pain - 0 and worst pain - 10) for each teeth.
Measured: This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion
Evaluation of patient's perception of satisfaction regarding their oral health
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?"
Measured: For this, an external examiner will apply the questionnaire prior to randomization and on 1, 12 and 24 month return visits.
Costs of each consultation performed through study completion
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start30 Aug 2018
- Primary completion30 Jun 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Enamel HypoplasiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana Pion Antonio, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614819
- Sponsor's protocol ID
- MIHForp
- Status last verified
- May 2023
- First submitted
- 14 Jun 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Used in the Treatment of Hypomineralized Occlusal Lesions in Teeth Enamel Affected by MIH: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03614819
- Acronym / sponsor ID
- MIHForp
- Conditions
- Dental Enamel Hypoplasia
- Keywords
- Lasers, Dental enamel hypoplasia, Preventive dentistry, Dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diode laser group | Experimental | Procedure: Diode laser groupProphylaxis 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. |
| Glass Ionomer Sealing Group | Active comparator | Procedure: Glass Ionomer Sealing GroupProphylaxis 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diode laser groupProphylaxis 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 or surgery | Diode laser group |
| Glass Ionomer Sealing GroupProphylaxis 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 or surgery | Glass Ionomer Sealing Group |
Primary outcome
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).
5 secondary outcomes
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.
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]
Hypersensitivity to dentin
Time frame: This evaluation will be performed before treatment, 1 week, 1, 6, 12, 18 and 24 months after inclusion
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Related trials for Dental Enamel Hypoplasia
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser group and Glass Ionomer Sealing Group in people with Dental Enamel Hypoplasia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.