UMIN-CTR Clinical Trial

Basic information
Public title	Quantitative evaluation of dental manifestations of pediatric HPP patients using panoramic radiographs
Acronym	Dental study in pediatric patients with HPP
Scientific Title	Quantitative evaluation of dental manifestations of pediatric HPP patients using panoramic radiographs
Scientific Title:Acronym	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	1st name Kazuhiko Middle name Last name Nakano
Organization	Graduate School of Dentistry, Osaka University
Division name	Dept. of Pediatric Dentistry
Zip code	5650871
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	1st name Rena Middle name Last name Okawa
Organization	Osaka University Dental Hospital
Division name	Dept. of Pediatric Dentistry
Zip code	5650871
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)

IRB Contact (For public release)
Organization	Graduate School of Dentistry, Osaka University
Address	1-8 Yamada-oka, Suita, Osaka, Japan
Tel	06-6879-2962
Email	nakano@dent.osaka-u.ac.jp

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

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	under collection of data
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 10 Day
Date of IRB
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

Other
Other related information	under construction of analysis plan

Management information
Registered date	2018 Year 08 Month 03 Day
Last modified on	2020 Year 08 Month 04 Day

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