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Efficacy of desensitizing toothpastes containing hydroxylapatite vs fluoride for hypersensitivity relief in MIH (Molar-Incisor-Hypomineralisation)-affected molars in children and adolescents

Efficacy of desensitizing toothpastes containing hydroxylapatite vs fluoride for hypersensitivity relief in MIH (Molar-Incisor-Hypomineralisation)-affected molars in children and adolescents - Evaluation of hypersensitivity relief in children and adolescents with MIH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020359
Enrollment
40
Registered
2019-12-19
Start date
2020-01-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

MIH (Molar Incisor Hypomineralisation).

Interventions

Group 1: Kinder Karex toothpaste
Manufacturer: Dr. WOLFF GmbH & Co. KG, Bielefeld, Germany
contains 10% hydroxylapatite. Application: twice per day for 8 weeks. Group 2: Elmex Junior toothpaste
Manufacturer: CP GABA GmbH, Hamburg, Germany
contains 1400 ppm Fluoride. Application: twice per day for 8 weeks.

Sponsors

Dr. Kurt Wolff GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: Age: 6 - 16 years, gender: female and male, at least one MIH-affected molar with hypersensitivity. Air stimulus: hypersensitivity SCASS > 1. Tactile stimulus: pain 0,5 < VAS < 9,5 (0 = no pain, 10 = strongest pain).

Exclusion criteria

Exclusion criteria: No MIH. MIH-affected molar with no hypersensitivity. Air stimulus: hypersensitivity SCASS = 0 or SCASS = 1. Tactile stimulus: pain VAS = 0 (0 = no pain).

Design outcomes

Primary

MeasureTime frame
Hypersensitivity VAS after 56 +/-3 days.

Secondary

MeasureTime frame
Hypersensitivity VAS after 28 +/-3 days, hypersensitivity SCASS after 28 +/-3 days and after 56 +/-3 days, API after 28 +/-3 days and after 56 +/-3 days, taste of the toothpaste, evaluation and acceptance of the toothpaste.

Countries

Germany

Contacts

Public ContactNelly Kary

Universitätsmedizin Mainz Poliklinik für Parodontologie und Zahnerhaltung

nelly.kary@unimedizin-mainz.de06131177247

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026