A Phase 1/2 interventional study of Antimicrobial PDT and Papacarie Deproteinization and Conventional caries treatment in Hypomineralization Molar Incisor, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
Introduction: Molar Incisor Hypomineralization (MIH) is a qualitative defect of enamel development that occurs in the mineralization phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control. The longevity of the restorations will also be evaluated after the deproteinization procedure. Methods and analysis: Patients 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinization with Papacárie Duo; Group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinization with a 5% sodium hypochlorite solution; Group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and post-eruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the chi-squared test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using ANOVA and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.
121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.
This study's planned enrollment of 69 is above the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.
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Exclusion Criteria:
The participants will receive selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity using a curette, followed by the application of antimicrobial PDT and deproteination with Papacárie DuoTM.
Procedure: Antimicrobial PDT and Papacarie Deproteinization
The participants will receive selective removal of carious dentinal tissue using a curette, followed by application of antimicrobial PDT and deproteination with NaClO 5%.
Procedure: Antimicrobial PDT and 5% NaOCl Deproteinization
The participants will receive selective removal of carious dentinal tissue using a curette.
Procedure: Conventional caries treatment
Selective removal of carious tissue with curette + antimicrobial PDT (methylene blue 5 Evilux, Color index 52015, Fórmula \& Ação + red laser at 660 nm) + deproteinization of enamel with Papacárie DuoTM + restoration.
Selective removal of carious tissue with curette + restoration.
Selective removal of carious tissue with curette + application of methylene blue and low-level laser (aPDT) + deproteinization of adjacent enamel with 5% NaOCl + restoration.
Change in retention of the restorative material in the cavity
The effects of deproteination on the longevity of the restoration will be evaluated using the modified USPHS index, in which retention, marginal integrity, marginaldiscoloration, anatomic form and secondary caries are evaluated.
Time frame: 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.
Change in microbiological evaluation
Prior to the removal of the carious tissue, a sample infected dentin will be collected from each selected tooth. Immediately after the removal of the carious tissue and the application of aPDT, a sample of the remaining dentin will be collected. The results will be expressed as colony-forming units of SM and LB as well as proportion of streptococci (% S/TM), streptococci of the mutans group (% SM/TM) and lactobacilli (% LB/TM) in relation to the total of viable microorganisms. For SM, the proportion in relation to the total of streptococci (% SM/S) will also be calculated.
Time frame: Baseline and immediately after treatment.
Change in Dental Sensitivity
Prior to the removal of the carious tissue, the volunteers in the different groups will indicate the degree of pain or discomfort on the visual analog scale (VAS) following isolation of the neighboring teeth and the application of compressed air to the tooth with MIH for 3 seconds.
Time frame: Baseline, 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.
Plan to share: Yes — The information collected from the participants will be transcribed into a database replacing the individuals' names with the registration number of the evaluation form. The datasets (Excel spreadsheets) generated from this protocol will be available from the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) upon any reasonable request. However, reuse of this data will not be permitted for anyone who is not an author of this paper.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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