UMIN-ICDS Clinical Trial

Public title

A study on changes in oral and facial growth in continuous treatment of cleft lip and palate

Acronym

Changes in oral and facial growth of patients with cleft lip and palate

Scientific Title

A study on changes in oral and facial growth in continuous treatment of cleft lip and palate

Scientific Title:Acronym

Changes in oral and facial growth of patients with cleft lip and palate

Region

Japan

Condition

Cleft lip and palates

Classification by specialty

Oral surgery

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Generally, surgical procedures are performed to close the cleft in the lip and palate. While surgery allows for recovery of aesthetics and function, the surgical invasion can sometimes inhibit maxillary growth. In addition, until the growth of the upper jaw is complete, there may be distortions in the lip and external nose appearance after lip reconstruction surgery. Therefore, a surgical method that can achieve good lip and external nose appearance and speech function, while avoiding maxillary growth restriction and minimizing distortions of the lip and external nose, is desired.
Treatments for CLP have established effective protocols at various domestic and international facilities. However, standard treatment based on domestic and global standards is not unified, and there is still debate on issues such as the effectiveness of pre-surgical treatments, the effectiveness of one-stage or two-stage lip and palate surgeries, and the optimal timing for bone grafting.
By conducting this research, it is expected that evaluating, analyzing, and examining oral and maxillofacial growth will lead to a reevaluation of current treatment methods and the development of new treatments.
In addition, for CLP treatment, it is necessary to constantly evaluate established protocols for things like pre-surgical orthodontic treatment, facial evaluation before and after lip reconstruction, facial evaluation before and after lip and nose revision surgery, and maxillofacial growth assessment. We believe it is important to evaluate treatment at our hospital based on the assessment criteria used in studies such as Americleft (2011, 2016) and the UK Cleft Study (2015).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Facial appearance and growth evaluations are conducted using digital photographs and three-dimensional images, plaster models, and standardized head X-rays taken during the diagnostic and treatment processes. Morphological and aesthetic evaluations of the face, as well as assessments of the surgical procedures, are performed using digital and three-dimensional photographs taken before surgery, one month after surgery, and one year after surgery. For aesthetic evaluation, a scale modified with reference to the method proposed by Asher-McDate in 1991 and by J.B. Kim in 2011, which evaluates post-cleft lip aesthetic facial appearance on a five-point scale, is used. Additionally, photographs are taken using the 3-dimensional surface high-speed imaging and analysis systems 3dMD (LLC, USA) and Vectra (Canfield, USA), and measurements and analyses are carried out using the shape analysis software 3D-Rugle (Medic Engineering, Japan) and Mirror PhotoFile.

For the fabrication of Hotz plates, maxillary models produced every 2 to 3 months from birth to one year of age, and for the creation of surgical splints, maxillary models made at 1 year, 1.5 years, and 3 years of age are utilized. Additionally, upper and lower jaw models and lateral cephalometric X-rays created or photographed at 5, 10, and 15 years of age are used as the subjects. The morphology of the jaw models is digitized using a non-contact three-dimensional digitizer Maestro 3D (AGE Solutions S.r.l., Italy), and measurements and analyses are performed using the shape analysis software 3D-Rugle (Medic Engineering, Japan). Lateral cephalometric X-rays are analyzed using the analysis software WinCeph ver. 9.0 (Rise, Japan).

Key secondary outcomes

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

1

months-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

From birth, cleft lip and palate (CLP) are observed, and it applies to all patients receiving comprehensive treatment for cleft lip and palate at our hospital.

Key exclusion criteria

People who wanted to give consent for the research (themselves or their guardians) or patients with the syndrome

Target sample size

100

Name of lead principal investigator

1st name	Susumu
Middle name
Last name	Tanaka

Organization

The University of Osaka, Graduate School of Dentistry

Division name

Department of Oral and Maxillofacial Surgery

Zip code

565-0871

Address

1-8 Yamadaoka, Suita City, Osaka, Japan

TEL

0668792936

Email

isomura.emiko.dent@osaka-u.ac.jp

Name of contact person

1st name	Emiko
Middle name	Tanaka
Last name	Isomura

Organization

The University of Osaka, Graduate School of Dentistry

Division name

Department of Oral and Maxillofacial Surgery

Zip code

565-0871

Address

1-8 Yamadaoka, Suita City, Osaka, Japan

TEL

0668792936

Homepage URL

Email

isomura.emiko.dent@osaka-u.ac.jp

Institute

The University of Osaka

Institute

Department

Personal name

Organization

the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The University of Osaka

Address

1-8 Yamadaoka, Suita City, Osaka, Japan

Tel

0668792936

Email

isomura.emiko.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

2026

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Enrolling by invitation

Date of protocol fixation

2022

Year

07

Month

20

Day

Date of IRB

2022

Year

11

Month

10

Day

Anticipated trial start date

2022

Year

11

Month

11

Day

Last follow-up date

2042

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The details of the observations are already described in the methods. As for handling personal information, any description that could identify a specific individual from the participants' data or samples, like names, is removed. Instead, new codes or numbers are assigned to anonymize the participants, and a correspondence table linking the participants to these codes (numbers) is created by our department (our hospital) and Osaka University. The person in charge of managing personal information keeps it strictly to prevent any leaks to the outside.

Registered date

2026

Year

11

Month

12

Day

Last modified on

2026

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072674