UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016561
Receipt number R000019217
Scientific Title Assessment of the evaluating method for a spontaneous healing process at the extracted socket
Date of disclosure of the study information 2015/02/17
Last modified on 2015/02/17 14:34:36

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Basic information

Public title

Assessment of the evaluating method for a spontaneous healing process at the extracted socket

Acronym

Assessment of the evaluating method for a spontaneous healing process at the extracted socket

Scientific Title

Assessment of the evaluating method for a spontaneous healing process at the extracted socket

Scientific Title:Acronym

Assessment of the evaluating method for a spontaneous healing process at the extracted socket

Region

Japan


Condition

Condition

Patient whose dental extraction is planned

Classification by specialty

Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In patients whose dental extraction is planned, the post-operative changes will be evaluated during the spontaneous healing process at the extracted socket, in terms of the bone density ratio of newly generated bone and the radiological observations.

Basic objectives2

Others

Basic objectives -Others

Evaluation of post-operative changes in the bone density ratio of newly generated bone and the radiological observations

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1 The bone density ratio
2 Radiological evaluation

Key secondary outcomes

1 Height of alveolar bone
2 Width of alveolar bone


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

50 years-old >

Gender

Male and Female

Key inclusion criteria

Patient:
1)whose extraction site is either one of between incisor and second premolar or mandibular third molars
2)with remaining dental root more than half at the extraction site
3)whose extracted socket would be possibly fulfilled with the bone
4)who has sufficient keratinized gingiva to cover the extracted socket
5)with a prior written consent
6)who is 20 years and older, and younger than 50 years at the time of consent
7)who can maintain a good oral hygiene condition during the follow-up term

Key exclusion criteria

1)Issues affecting evaluation of safety
Patient:
1 with traumatic bone defect
2 whose surgical treatment (GBR, implant, etc) is planned in 24 weeks after the extraction, or has been done in 24 weeks before, in the same jaw where the extraction is planned
3 with untreated severe periodontal disease or caries (moderate or severe in adult periodontitis, or C4 grade in caries)
2)Issues affecting patient safety
Patient:
1 who was regularly smoking till 24 weeks before the extraction, or will possibly smoke during the follow-up term
2 of diabetes not under control
3 who has had an irradiation record at head and neck region
4 with severe metabolic bone disease (osteoporosis, osteomalacia, rachitis, etc)
5 who took drugs affecting bone metabolism (bis-phosphonate, calcitonine, etc)
3)Issues affecting evaluation of efficacy
Patient:
1 who has an implant adjacent to the extraction site
2 whose teeth adjacent to the extraction site has a metal nail (screw post)
3 whose teeth adjacent to the extraction site has a metal prosthesis fully covering the crown down to alveolar bone
4 having metal subjects that might cause artifact in CT image up to the same level as extracted alveolar bone
4)General consideration
Patient:
1 who has a history of infection disease, or is in danger of it
2 in pregnancy or of possible pregnancy, or seeking pregnant, or during breast-feeding
3 who has a history of autoimmune diseases
4 in unstable or fatal in clinical condition (that might require urgent treatment)
5 with clinically serious organ disorder (heart failure of NYHA Class IV, arrhythmia such as ventricle tachycardia, fibrillation and flutter, adult respiratory distress syndrome, and for kidney, blood, metabolic/electrolyte abnormality and circulatory, in grade 3 defined in the 80th notification by MHW issued on June 29, 1992.
6 who was using a investigational device or drugs within one year before participating this study
7 who was judged disqualified as the subject by a principal investigator or sub-investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Kakudo

Organization

Osaka Dental University

Division name

Second Department of Oral and Maxillofacial Surgery

Zip code


Address

1-5-17 Otemae, Chuo-Ku, Osaka

TEL

06-6910-1076

Email

kakudo@cc.osaka-dent.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Kakudo

Organization

Osaka Dental University

Division name

Second Department of Oral and Maxillofacial Surgery

Zip code


Address

1-5-17 Otemae, Chuo-Ku, Osaka

TEL

06-6910-1076

Homepage URL


Email

kakudo@cc.osaka-dent.ac.jp


Sponsor or person

Institute

Osaka Dental University

Institute

Department

Personal name



Funding Source

Organization

KYOCERA Medical Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

大阪歯科大学附属病院(大阪府) Osaka Dental University Hospital
神奈川歯科大学附属病院(神奈川県)Kanagawa Dental University Hospital
鶴見大学歯学部(神奈川県) Tsurumi University School of Dental Medicine


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 17 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


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

Completed

Date of protocol fixation

2007 Year 02 Month 27 Day

Date of IRB


Anticipated trial start date

2007 Year 08 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

prospective study


Management information

Registered date

2015 Year 02 Month 17 Day

Last modified on

2015 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019217


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name