UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000041079
Receipt number	R000046909
Scientific Title	Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.
Date of disclosure of the study information	2020/08/01
Last modified on	2025/07/16 09:54:04

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Basic information

Public title

Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.

Acronym

Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.

Scientific Title

Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.

Scientific Title:Acronym

Retrospective Study for factors impacting on the final outcomes of alveolar bone grafting evaluated in adulthood.

Region

Japan

Condition

cleft lip and or palate

Classification by specialty

Plastic surgery Dental medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The purpose of this study is to examine the factors impacting on the X-ray evaluation of alveolar bone in the permanent dentition with CT evaluation just after the bone graft, orthodontic works and the other factors associated with the patient.

Basic objectives2

Others

Basic objectives -Others

To investigate the factors that influence the alveolar height of the bone graft in the permanent dentition of patients with alveolar bone grafting.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

"Bergrand evaluation of alveolus by dental Xp before the final orthodontic treatment" and "Bergrand evaluation by dental Xp after the final orthodontic treatment"

Key secondary outcomes

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The objects of this study are patients aged 20 years or older at the date of March 31, 2019, who underwent alveolar bone grafting during the primary or mixed dentition stage at Plastic and Reconstructive Surgery in Tohoku University Hospital. In addition, the objects are underwent continuous oral care at the Clinics for Maxillo-Oral Disorders in the dental center of Tohoku University Hospital.

Key exclusion criteria

Cases where medical records such as CT and X-ray are not available. Cases that include conditions other than CT findings in the decision of CT evaluation and cases that have complications due to factors that are not related to surgery or tooth status, such as failure to observe postoperative dietary restrictions, will also be excluded from the target.

Target sample size

150

Research contact person

Name of lead principal investigator

1st name Yoshimichi

Middle name

Last name imai

Organization

Tohoku University, School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

9808575

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7332

Email

yo-imai@med.tohoku.ac.jp

Public contact

Name of contact person

1st name Yoshimichi

Middle name

Last name Imai

Organization

Tohoku University, School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

980-8575

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7332

Homepage URL

Email

yo-imai@med.tohoku.ac.jp

Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name

Funding Source

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Tohoku University Graduate school of Dentistry, Clinics for Orthodontics and Speech Therapy for Craniofacial Anomalies

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Tohoku University School of Medicine

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-728-4105

Email

rinri-2@proj.med.tohoku.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学病院

Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 01 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

https://doi.org/10.1016/j.heliyon.2025.e43116

Number of participants that the trial has enrolled

153

Results

The modified Bergland index worsened in 23 (30.7 %) of the 75 treated cases, while no worsening was observed in the control group (P <0.001). The proportion of modified Bergland index worsening was significantly associated with the presence or absence of a lateral incisor, the order of tooth alignment in the cleft area, and the timing of alveolar bone grafting. No cases demonstrated modified Bergland index worsening during the retention phase.

Results date posted

2025 Year 07 Month 16 Day

Results Delayed

Delay expected

Results Delay Reason

The reviewers instructed us to make a major change in the analysis method.

Date of the first journal publication of results

2025 Year 04 Month 26 Day

Baseline Characteristics

We included 153 consecutive patients with unilateral CLP (UCLP) who underwent ABG between 1998 and 2014 at the Department of Plastic and Reconstructive Surgery, who had adequate medical and X-ray records, and who were receiving continuous treatment and follow-up by our team. None of the included patients had chromosomal or other major abnormalities. The timeframe for long-term evaluation was from 1998 until 2023. All patients were invited to follow-up radiographic examination; six patients did not respond. We excluded 35 patients because 11 required repeat ABG, three received a dental implant into the grafted alveolus, one had a missing lateral incisor replaced with a bridge prosthesis, and 20 were transferred to another hospital due to relocating. All patients underwent ABG using particulate cancellous bone and marrow graft harvested from the iliac crest, and the same surgeon performed all operations.

Participant flow

Included patients were allocated to three groups, as follows. The control group received only phase-1 treatment (2x4 and/or lingual arch) and did not receive phase-2 treatment (because they had difficulty attending the hospital regularly, were satisfied with the first-phase treatment result, and refused to fix the edgewise appliance). The treatment group received both phase-1 and phase-2 treatments with an edgewise appliance. The retention group were patients in the treatment group with a retention phase lasting more than 12 months in the treatment group. The lingual arch (0.036 inch) with 0.020-inch stainless steel spring wire used in phase-1 treatment corrected anterior crossbite and moved teeth into the grafted bone area. Both phase-1 treatment (2x4) and phase-2 treatment were provided with preadjusted edgewise fixed appliances of Roth prescription, 0.018- x0.025-inch brackets. The phase-1 treatment was mostly nickel-titanium wires of 0.014, 0.016, 0.016- x0.022, and stainless-steel wires of 0.016- x0.022-inch dimensions, the phase-2 treatment was mostly nickel-titanium wires of 0.014, 0.016, 0.018, 0.016- x0.022, 0.017- x0.025, and stainless-steel wires of 0.016- x0.022, 0.017- x0.025-inch dimensions were placed for leveling and alignment. Specifically, comprehensive records were traced for 75 patients (male: 42, female: 33) who underwent phase-2 treatment. Furthermore, 53 patients (male: 31, female: 22) in the treatment group were selected as the retention group. Additionally, 37 patients (male: 25, female: 12) who did not undergo phase-2 treatment were selected as controls from the Department of Orthodontics and Speech Therapy for Craniofacial Anomalies, in Tohoku University Hospital. The flow of patient selection is summarized in Fig. 1. The mean ages of the phase-2-treated patients at ABG (T0-1), beginning of phase-1 (T0-2), and beginning (T1) and end (T2) of phase-2 were 8.2 (SD 1.6) years, 9.5 (SD 1.8) years, 15.3 (SD 2.3) years, and 18.8 (SD 2.6) years. The mean age of those undergoing retention (T3) was 20.5 years (SD 3.9), respectively. The mean ages of the control group at T0-1, T0-2, T1, and T2 were 7.9 (SD 1.1) years, 9.7 (SD 1.2) years, 14.9 (SD 1.2) years, and 18.1 (SD 1.3) years, respectively. There were no significant differences in age between the control group and phase-2 treatment group at T0-1, T0-2, T1, and T2, respectively. T1 and T2 periapical radiographs of the control group were taken in approximately the same period as those of the treatment group. At the start of phase-1 treatment, 29 clefts were aligned with the central incisor-lateral incisor-canine alignment. In 11 of these cases, lateral incisors were extracted during phase-2 treatment, whereas it was not extracted in 18 cases. Additionally, at the start of phase-1 treatment, 46 clefts were aligned with the central incisor-canine alignment. In five of these cases, a lateral incisor on the cleft side was extracted during phase-1 treatment, while 41 cases had a congenitally missing lateral incisor. In all included cases with a missing lateral incisor on the cleft side (both congenitally missing and extracted teeth), the space was closed during phase-2 treatment. Hence, at the end of phase-2 treatment, in 18 cases, the cleft was aligned with the central incisor-lateral incisor-canine alignment, while that in 57 cases was aligned with the central incisor-canine alignment. The orthodontic treatment and ABG of all patients were performed according to the protocol. The acceptance-success criteria for grafted bone, i.e., a bone height exceeding 8 mm on CT images obtained 6 months after the bone graft, were confirmed by more than two orthodontists and plastic surgeons. Re-bone graft was performed in principle when it was 8 mm or less and was excluded from the study samples.

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 07 Month 13 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry

2023 Year 09 Month 30 Day

Date trial data considered complete

2023 Year 09 Month 30 Day

Date analysis concluded

2025 Year 03 Month 01 Day

Other

Other related information

The medical informations were acquired in a retrospective review of medical and dental records.

Management information

Registered date

2020 Year 07 Month 12 Day

Last modified on

2025 Year 07 Month 16 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046909