Evaluation of Antimicrobial Photodynamic Therapy and Minimal Intervention Associated With Deproteinization in Permanent Teeth With Molar Incisor Hypomineralization

November 22, 2023 updated by: Sandra Kalil Bussadori, University of Nove de Julho

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 03155-000
        • Recruiting
        • Nove de Julho University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control group
The participants will receive selective removal of carious dentinal tissue using a curette.
Procedure: Conventional caries treatment
Selective removal of carious tissue with curette + restoration.
Experimental: Antimicrobial PDT and Papacarie Deproteination Group
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
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.
Experimental: Antimicrobial PDT group and deproteination with NaClO 5% group
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
Selective removal of carious tissue with curette + application of methylene blue and low-level laser (aPDT) + deproteinization of adjacent enamel with 5% NaOCl + restoration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in retention of the restorative material in the cavity
Time Frame: 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.
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.
48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in microbiological evaluation
Time Frame: Baseline and immediately after treatment.
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.
Baseline and immediately after treatment.
Change in Dental Sensitivity
Time Frame: Baseline, 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.
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.
Baseline, 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AmandaHMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available as soon as the article with the findings will be published in a peer-reviewed journal.

IPD Sharing Access Criteria

The datasets from this protocol will be available from the corresponding author (Sandra Kalil Bussadori -sandra.skb@gmail.com) upon any reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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