Efficacy of a Toothpaste Based on Microcrystalline Hydroxyapatite on Children with Hypersensitivity Caused by MIH: A Randomised Controlled Trial.
Oral Health Prev Dent
; 19(1): 647-658, 2021 Jan 07.
Article
in English
| MEDLINE | ID: covidwho-1555361
ABSTRACT
PURPOSE:
Hypersensitivity is a frequent complaint in children with molar incisor hypomineralisation (MIH). This double-blind randomised controlled trial aimed to evaluate non-inferiority in hypersensitivity relief of a toothpaste containing microcrystalline hydroxyapatite compared to amine fluoride in children with MIH. MATERIALS ANDMETHODS:
Children were randomised into 2 groups either hydroxyapatite (intervention) or amine fluoride toothpaste (control). The primary endpoint was pain sensation in response to tactile stimulus (Wong-Baker FACES Pain Rating Scale) 56 days after randomisation and analysed by mixed effects linear regression analysis. Non-inferiority was inferred if the upper limit of the one-sided 95% confidence interval (CI) of the difference between intervention and control group was below the non-inferiority margin of 1 in the ITT (intention-to-treat) and PP (per protocol) population.RESULTS:
Twenty-one children were randomised and 14 children finished the study per protocol. In the ITT population, hydroxyapatite was non-inferior to amine fluoride (mean difference -0.75 95%CI [-∞;0.49]). In the PP population, non-inferiority could not be shown (-0.62 [-∞;1.08]).CONCLUSIONS:
Overall non-inferiority in hypersensitivity relief of a toothpaste containing hydroxyapatite compared to amine fluoride could not be shown. However, the hydroxyapatite group tended to be less hypersensitive in both populations. Attrition of the PP population due to the COVID-19 pandemic led to loss of statistical power.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Dental Enamel Hypoplasia
/
Dentin Sensitivity
/
Dentin Desensitizing Agents
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Child
/
Humans
Language:
English
Journal:
Oral Health Prev Dent
Journal subject:
Dentistry
Year:
2021
Document Type:
Article
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