Molar Incisor HypomineralizationPhase 1NCT03826810
Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH
A Phase 1 study testing aPDT and ART in people with Molar Incisor Hypomineralization, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization (MIH). The study was composed of Groups (1 and 2). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- aPDT and ART
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2018to 30 Dec 2018
- Phase
- Phase 1
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children, without systemic alterations;
- Collaborative children;
- Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement.
Who cannot join
- Child with systemic impairment;
- Non-cooperative behavior;
- Carious lesion of Class II, III, IV or V type of Black;
- Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration;
- Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdades Integradas Da União Educacional Do Planalto Central
Gama, Federal District, 72445-020
About this study
Official title: Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH - Controlled Clinical Trial
The objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity, indicated for clinical restorative treatment. Photodynamic therapy was applied with the use of low-intensity laser in permanent teeth selected for the treatment of infected dentin in G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis. For the evaluation of the association of categorical variables like age and gender, the Chi-square test and Fisher's exact test were used. To analyze the correlation between the continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were applied for the analysis of dentin density in the radiographic images scanned and the microbiological results for colony forming units.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- aPDT, ART
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aPDTRadiation
For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.
ARTProcedure or surgery
Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
| Study group | Role | What they receive |
|---|---|---|
| aPDT + ART group | Experimental | In this group, both aPDT and ART were performed. Receives: Radiation: aPDT; Procedure: ART |
| ART group | Experimental | In this group, only ART was performed. Receives: Procedure: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dentin sensitivity
Prior to removal of carious tissue, the volunteers responded to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS was repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).
Measured: Before and immediately after treatment.
Secondary outcomes (3)
Change in colony forming units
Microbiological specimens were collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.
Measured: Before and immediately after treatment.
Change in dentin density
The objective was to quantitatively determine the gray tones of the affected dentin region just below the glass ionomer restoration, whose radiographic control for visualization of the healthy dentin allows the clinical evaluator of the study to compare the treated groups with the density of the remaining dentin in discussion. The statistical analysis of the optical density were made according to the mixed effects model.
Measured: After 6 and 12 months.
Change in the presence of cavity filling
The evaluation scores will be evaluated based on the results of studies by other authors (Frencken, et al., 1996). Digital photos (Canon Sx500 IS Camera) will be taken of all the teeth and, from these photographs, the teeth will be classified as follows:
0 = present, without defect.
- = present, small defects in the margin less than 0.5 mm deep, no need for repair.
- = present, small defects in the margin of 0.5 to 1 mm depth, needs repair.
- = present, gross defects in the margin of 1 mm or more in depth, needs repair.
- = absent, restoration almost / completely lost, needs treatment.
- = absent, other treatment was performed for any other reason.
- = tooth missing due to any reason.
- = present, surface wear less than 0.5 mm, no need for replacement.
- = present, surface wear greater than 0.5 mm, need replacement.
- = impossible to diagnose.
Measured: After 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Jan 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826810
- Sponsor's protocol ID
- Leticia
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH - Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03826810
- Acronym / sponsor ID
- Leticia
- Conditions
- Molar Incisor Hypomineralization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 1 Feb 2019 (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.
The objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity, indicated for clinical restorative treatment. Photodynamic therapy was applied with the use of low-intensity laser in permanent teeth selected for the treatment of infected dentin in G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis. For the evaluation of the association of categorical variables like age and gender, the Chi-square test and Fisher's exact test were used. To analyze the correlation between the continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were applied for the analysis of dentin density in the radiographic images scanned and the microbiological results for colony forming units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aPDT + ART group | Experimental | Radiation: aPDT, Procedure: ARTIn this group, both aPDT and ART were performed. |
| ART group | Experimental | Procedure: ARTIn this group, only ART was performed. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children, without systemic alterations;
- Collaborative children;
- Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement.
Key exclusion criteria (5 listed)
- Child with systemic impairment;
- Non-cooperative behavior;
- Carious lesion of Class II, III, IV or V type of Black;
- Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration;
- Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
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 |
|---|---|---|
| aPDTFor the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity. | Radiation | aPDT + ART group |
| ARTRemoval of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement. | Procedure or surgery | ART group, aPDT + ART group |
Primary outcome
Change in dentin sensitivity
Time frame: Before and immediately after treatment.
Prior to removal of carious tissue, the volunteers responded to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS was repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).
3 secondary outcomes
Change in colony forming units
Time frame: Before and immediately after treatment.
Change in dentin density
Time frame: After 6 and 12 months.
Change in the presence of cavity filling
Time frame: After 6 and 12 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 22 Mar 2019.
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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 Phase 1 study testing aPDT and ART in people with Molar Incisor Hypomineralization, run by University of Nove de Julho 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 3 inclusion and 5 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 22 Mar 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in dentin sensitivity (time frame: Before and immediately after treatment.). 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 22 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.