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Hypomineralization Molar IncisorPhase 1/2NCT05443035

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

A Phase 1/2 study testing Antimicrobial PDT and Papacarie Deproteinization, Conventional caries treatment and Antimicrobial PDT and 5% NaOCl Deproteinization in people with Hypomineralization Molar Incisor, run by University of Nove de Julho at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Hypomineralization Molar Incisor
What is being tested?
Antimicrobial PDT and Papacarie Deproteinization, Conventional caries treatment and Antimicrobial PDT and 5% NaOCl Deproteinization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteBrazil
Study dates
20 Aug 2023to 20 Mar 2024
Phase
Phase 1/2
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 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • Nove de Julho University

    São Paulo, São Paulo, 03155-000

    Sandra K Bussadori, PhD, +55 11 2633-9000, sandra.skb@gmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Being tested
Antimicrobial PDT and Papacarie Deproteinization, Conventional caries treatment, Antimicrobial PDT and 5% NaOCl Deproteinization
Medical subject headings
Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antimicrobial PDT and Papacarie DeproteinizationProcedure or surgery

    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.

  • Conventional caries treatmentProcedure or surgery

    Selective removal of carious tissue with curette + restoration.

  • Antimicrobial PDT and 5% NaOCl DeproteinizationProcedure or surgery

    Selective removal of carious tissue with curette + application of methylene blue and low-level laser (aPDT) + deproteinization of adjacent enamel with 5% NaOCl + restoration.

Study groups in NCT05443035
Study groupRoleWhat they receive
Antimicrobial PDT and Papacarie Deproteination GroupExperimentalThe 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.
Receives: Procedure: Antimicrobial PDT and Papacarie Deproteinization
Antimicrobial PDT group and deproteination with NaClO 5% groupExperimentalThe participants will receive selective removal of carious dentinal tissue using a curette, followed by application of antimicrobial PDT and deproteination with NaClO 5%.
Receives: Procedure: Antimicrobial PDT and 5% NaOCl Deproteinization
Control groupExperimentalThe participants will receive selective removal of carious dentinal tissue using a curette.
Receives: Procedure: Conventional caries treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and immediately after treatment.

  2. 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.

    Measured: Baseline, 48 hours after the restorative treatment and at three-months intervals for a period of 12 months of follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start20 Aug 2023
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Mar 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443035
Sponsor's protocol ID
AmandaHMI
Status last verified
Nov 2023
First submitted
29 Jun 2022
Last updated
28 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Mandetta ARH, Bortoletto CC, Sobral APT, Goncalves MLL, Motta LJ, Horliana ACRT, Ferrari RAM, Prates RA, Deana AM, Cordeiro RCL, Pinto LAMDS, Fernandes KPS, Bussadori SK. Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial. BMJ Open. 2023 Dec 14;13(12):e076226. doi: 10.1136/bmjopen-2023-076226.

    PubMed 38101830

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Antimicrobial PDT and Papacarie Deproteinization, Conventional caries treatment and Antimicrobial PDT and 5% NaOCl Deproteinization in people with Hypomineralization Molar Incisor, 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 4 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: status not confirmed, as of the sponsor's last update on 28 Nov 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.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443035, which also lists 1 linked publication.

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 28 Nov 2023.

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