UMIN-CTR Clinical Trial

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

Hypophosphatasia

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka University

Institute

Department

Personal name

Organization

Alexion Pharma GK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

under construction of analysis plan

Registered date

2018

Year

08

Month

03

Day

Last modified on

2020

Year

08

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038326