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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033623
Receipt No. R000038326
Official scientific title of the study Quantitative evaluation of dental manifestations of pediatric HPP patients using panoramic radiographs
Date of disclosure of the study information 2018/08/03
Last modified on 2018/08/03

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Basic information
Official scientific title of the study Quantitative evaluation of dental manifestations of pediatric HPP patients using panoramic radiographs
Title of the study (Brief title) Dental study in pediatric patients with HPP
Region
Japan

Condition
Condition Hypophosphatasia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The primary objective of this study is to conduct panoramic radiography using the indicator (reference object for quantifying bone density and the degree of alveolar crest resorption) and quantitatively visualize dental lesions in the pediatric patients with hypophosphatasia (HPP).
Basic objectives2 Others
Basic objectives -Others The secondary objectives of the study are:
To quantify the data obtained from the panoramic radiographs taken using the indicator in order to reveal the differences and similarities between pediatric HPP patients and healthy subjects.
To investigate the correlation between the data obtained using panoramic radiographs and dental manifestations in order to detect the risk factors leading to exfoliation.
Exploratory objectives of this study are:
To evaluate the differences and similarities in dental manifestations in pediatric HPP patients among clinical types, i.e., perinatal, infantile, childhood and odonto types, and among ALPL gene variants .
To investigate the applicability of the quantitative indices for measurement of dental lesions which possibly change by therapeutic intervention in HPP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The data on the following items from healthy subjects and HPP patients will be collected from the panoramic radiographic images obtained using the indicator.
Bone density of alveolar bone
The degree of alveolar crest resorption (CEJ-ABC distance)
Dental ages estimated by Haavikko's method
Key secondary outcomes Dental information of healthy subjects, and the data on dental manifestations in HPP patients irrespective of the presence or absence of therapeutic intervention (e.g., dosing of Asfotase alfa and/or dental care (tooth filling, dental pulp treatment, crown restoration, tooth extraction, denture, periodontal treatment etc.)) will be collected.
The data on the following items will be collected from the questionnaire survey and the panoramic radiographic images obtained using the indicator.
Items collected from a medical chart review used to complete a questionnaire;
Age
Gender
Age at the time of radiography
Dental formula
Dental complications (dentinogenesis imperfecta, amelogenesis imperfecta, gingivitis, periodontal disease, dental caries (including DMF index), morphological abnormality, etc.)
Dental treatment (treat or not, as well as treatment method and timing)
The following information will also be collected for HPP patients from a medical chart review used to complete a questionnaire.
Clinical types of HPP perinatal-, infantile-, childhood- or odontotypes)
Results of ALPL gene mutation analysis
Age at diagnosis of HPP
Exfoliation of premature teeth and permanent teeth at each position (number and age at exfoliation)
Depth of the periodontal pockets and the presence or absence of bleeding (premature teeth: 1 point method; permanent teeth: 6 points method)
Tooth mobility of premature teeth and permanent teeth (Grade 0,1, 2, 3)
Dental age

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects should meet the criteria 1 and 3, and HPP patients should meet the criteria 2 to 3.
1.Healthy children aged 2 years or older and 16 years or younger who can visit dentists and for whom panoramic photographs are applicable
2.Patients diagnosed as HPP aged 2 years or older and 16 years or younger who can visit dentists and for whom panoramic photographs need can to be taken
3.Informed consent can be obtained in writing from the study subjects/patients themselves or their legally authorized representatives
Key exclusion criteria Healthy subjects who fall under any of the following criteria 1 to 4, and pediatric HPP patients who fall under the criteria 3 or 4 will be excluded from enrollment in this study.
1.Those with severe dental caries, periodontal disease, etc.
2.Patients with skeletal dysplasia other than HPP
3.Those who have received dental treatment potentially affecting radiography
4.Those who are regarded as ineligible for enrollment in this study by the investigators
Target sample size 240

Research contact person
Name of lead principal investigator Kazuhiko Nakano
Organization Graduate School of Dentistry, Osaka University
Division name Dept. of Pediatric Dentistry
Address 1-8 Yamada-oka, Suita, Osaka, Japan
TEL +81-6-6879-2961
Email nakano@dent.osaka-u.ac.jp

Public contact
Name of contact person Rena Okawa
Organization Osaka University Dental Hospital
Division name Dept. of Pediatric Dentistry
Address 1-8 Yamada-oka, Suita, Osaka, Japan
TEL +81-6-6879-2370
Homepage URL
Email rokawa@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Alexion Pharma GK
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 03 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 11 Month 10 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results under collection of data
Other related information under construction of analysis plan

Management information
Registered date
2018 Year 08 Month 03 Day
Last modified on
2018 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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