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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05779332
Other study ID # 140
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date June 15, 2020

Study information

Verified date March 2023
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).


Description:

Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL. Six hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p<0.05 was statistical significant. .


Recruitment information / eligibility

Status Completed
Enrollment 655
Est. completion date June 15, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 9 Years
Eligibility Inclusion Criteria: - Being 9-year-old, - Mentally and physically capable of completing the questionnaire, - Presence of fully erupted 4 permanent molars and 8 permanent incisors. Exclusion Criteria: - Children were receiving orthodontic treatment during the examination, - Children had enamel hypoplasia or developmental defects, - Children had amelogenesis imperfecta or dental fluorosis.

Study Design


Intervention

Other:
survey application
Children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status.

Locations

Country Name City State
Turkey Sema Aydinoglu Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the prevalence and etiology of MIH. A questionnaire was applied to the parents about the etiological factors and the prevalence of MIH was determined by oral examination. up to four months
Primary To evaluate the impacts of MIH on oral health status. Oral health was evaluated by recording dmft (decayed, missing and filled teeth) and plaque index values. up to six months
Primary To evaluate the impacts of MIH on OHRQoL. The impact of MIH on quality of life (OHRQoL) was measured with the Child Perception Questionnaire (CPQ8-10). up to six months
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