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Efficacy of a profissional use paste with PRG technology in reducing Dental Plaque in children with Molar-Incisor Hypomineralization (MIH)

Efficacy of a prophylactic paste with PRG technology in reducing Dental Plaque index in children with Molar-Incisor Hypomineralization (MIH): an in situ and in vivo study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6p76t5x
Enrollment
Unknown
Registered
2024-11-06
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental Defects of Enamel

Interventions

This is a randomized controlled crossover clinical trial, blinded for outcome assessment. The intervention will be performed using three types of prophylactic agents: i) prophylactic paste with PRG te
ii) fluoride prophylactic paste (Herjos, Vigodent)
iii) pumice and water. All participants will undergo the three prophylactic agents in a crossover manner, after a 15-day washout period between interventions. Participants will be randomized and alloc

Sponsors

Faculdade de Odontologia da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia da Universidade de São Paulo
Collaborator

Eligibility

Age
7 Years to 17 Years

Inclusion criteria

Inclusion criteria: Minimum age of 7 and maximum age of 17 years; both sexes; diagnosis of Molar-Incisor Hypomineralization (MIH); signature of the Informed Consent Form (ICF) by the legal guardian and the Informed Assent Form (IAF) by the participant; high biofilm accumulation and poor oral hygiene

Exclusion criteria

Exclusion criteria: Presence of syndromes or general health conditions that prevent a complete clinical examination; children who do not allow the procedure; use of fixed appliances or metal bands that may interfere with the clinical examination of all tooth surfaces; children who are illiterate or semi-literate; patients requiring emergency treatment

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of a prophylactic paste with Pre-reacted Glass Ionomer (PRG) technology in reducing dental plaque index in permanent teeth of children with Molar-Incisor Hypomineralization (MIH)

Secondary

MeasureTime frame
To evaluate gingival health, dental caries, dentin hypersensitivity, oral health-related quality of life, and acceptability of the prophylaxis procedure in children with Molar-Incisor Hypomineralization (MIH)

Countries

Brazil

Contacts

Public ContactAna Carolina Gentile

Universidade de São Paulo

gentileeana@alumni.usp.br+55 (11) 97165-8991

Outcome results

None listed

Source: REBEC (via WHO ICTRP)