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

NCT ID: NCT05443035

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hypomineralization Molar Incisor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Antimicrobial PDT and Papacarie Deproteinization

Intervention Type 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 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%.

Group Type EXPERIMENTAL

Antimicrobial PDT and 5% NaOCl Deproteinization

Intervention Type 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.

Control group

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

Group Type EXPERIMENTAL

Conventional caries treatment

Intervention Type PROCEDURE

Selective removal of carious tissue with curette + restoration.

Interventions

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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.

Intervention Type PROCEDURE

Conventional caries treatment

Selective removal of carious tissue with curette + restoration.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Sandra Kalil Bussadori

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nove de Julho University

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Sandra K Bussadori, PhD

Role: primary

[email protected]
+55 11 2633-9000

References

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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.

Reference Type DERIVED
PMID: 38101830 (View on PubMed)

Other Identifiers

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AmandaHMI

Identifier Type: -

Identifier Source: org_study_id