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

NCT05443035 | Unknown Phase 1

• 1 other identifier: AmandaHMI
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypomineralization Molar Incisor

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Change in microbiological evaluation

  Baseline and immediately after treatment.

• Change in Dental Sensitivity

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

Study Arms (3)

Antimicrobial PDT and Papacarie Deproteination Group

EXPERIMENTAL

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

Antimicrobial PDT group and deproteination with NaClO 5% group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

The participants will receive selective removal of carious dentinal tissue using a curette.

Procedure: Conventional caries treatment

Interventions

Antimicrobial PDT and Papacarie Deproteinization PROCEDURE

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.

Antimicrobial PDT and Papacarie Deproteination Group

Conventional caries treatment PROCEDURE

Selective removal of carious tissue with curette + restoration.

Control group

Antimicrobial PDT and 5% NaOCl Deproteinization PROCEDURE

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

Antimicrobial PDT group and deproteination with NaClO 5% group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 03155-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 38101830 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor blinded to the allocation to the different groups will perform evaluations after 48 hours and at three-month intervals for a follow-up period of 12 months.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: August 20, 2023
• Primary Completion: December 20, 2023
• Study Completion: March 20, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available as soon as the article with the findings will be published in a peer-reviewed journal.
• 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.

Locations

BR (1)