Using light therapy to treat tooth enamel defects in children
Evaluation of Antimicrobial Photodynamic Therapy and Minimal Intervention Associated With Deproteinization in Permanent Teeth With Molar Incisor Hypomineralization: Study Protocol for a Clinical, Controlled, Blinded Trial.
PHASE1; PHASE2 · University of Nove de Julho · NCT05443035
This study is testing a new light therapy treatment for kids aged 8 to 12 with tooth enamel defects to see if it helps their teeth stay healthy longer.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 69 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | University of Nove de Julho (other) |
| Locations | 1 site (São Paulo, SP) |
| Trial ID | NCT05443035 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of antimicrobial photodynamic therapy (aPDT) combined with minimal intervention techniques for treating permanent teeth affected by Molar Incisor Hypomineralization (MIH) in children aged 8 to 12. Participants will be randomly assigned to different treatment groups, which include selective removal of carious tissue followed by aPDT and deproteinization. The study aims to assess both the clinical outcomes of the treatments and the longevity of the restorations after the deproteinization procedure. The goal is to improve dental health in children suffering from MIH.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 8 to 12 with at least one permanent first molar affected by MIH and active caries.
Not a fit: Patients with only enamel lesions, severe MIH without restorative treatment indications, or those with pulpal involvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less invasive treatments for children with enamel defects, improving their dental health and quality of life.
How similar studies have performed: While the specific combination of aPDT and minimal intervention for MIH is novel, similar approaches using aPDT in dental treatments have shown promising results in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy children with no adverse systemic conditions; * At least one permanent first molar with MIH and active caries on the dentin with post-eruptive fracture on a single surface or multiple surfaces with an indication for restorative treatment; direct view and access; no clinical or radiographic signs or symptoms of pulpal involvement; * Hypomineralized enamel with opacities near the margins of the cavities; * Occurrence or non-occurrence of dentinal sensitivity. Exclusion Criteria: * Clinically: carious lesion only involving the enamel, deficient restorations, small carious lesions in dentin (without access to manual excavator), hidden caries, clinical sign or symptom of pulpal involvement, clinical impossibility of restoration; * Radiographically: evidence of pulpal involvement; * Teeth severely affected by MIH without indication for restorative treatment; * Partially erupted teeth with MIH.
Where this trial is running
São Paulo, SP
- Nove de Julho University — São Paulo, SP, Brazil (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypomineralization Molar Incisor