UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000021342
Receipt number	R000024612
Scientific Title	Implant stability change for one-year postoperative stage after simultaneous implant placement with sinus graft for maxillary posterior region: Randomized clinical comparative study of PRF versus Bio-Oss
Date of disclosure of the study information	2016/03/08
Last modified on	2017/02/23 20:18:29

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Basic information

Public title

Implant stability change for one-year postoperative stage after simultaneous implant placement with sinus graft for maxillary posterior region: Randomized clinical comparative study of PRF versus Bio-Oss

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Missing tooth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To investigate the efficacy of platelet-rich fibrin (PRF) in the postoperative stage by comparing changes in implant stability over time until one year after simultaneous implant placement with sinus graft

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Assessment

Primary outcomes

implant stability quotient (ISQ) at implant placement, 1 week, 2 week, 1, 2, 3, 6 and 12 months

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Subjects used PRP at simultaneous implant placement with sinus graft

Interventions/Control_2

Subjects used Bio-Oss at simultaneous implant placement with sinus graft

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

(1) aged 20 years or older and had consented to participate in this study, (2) a missing tooth or teeth in the maxillary posterior region (first premolar to second molar), (3) require bone augmentation during implant placement, (4) adherence to the follow-up visits as scheduled, (5) Plaque Control Record of <25% in terms of O'Leary score during examination, (6) existing residual bone height being more than 4 mm

Key exclusion criteria

(1) having systemic or psychiatric disease that could affect implant treatment, (2) contradiction to oral surgical procedures, (3) participants to other clinical trials, (4) heavy bruxers or having clenching habit, (5) already undergone bone augmentation in the implant site, (6) having an untreated tooth or teeth requiring endodontic treatment adjacent to the implant placement site, (7) having teeth with 4 mm or deeper periodontal pockets, (8) smoking 10 or more cigarettes per day or were unable to quit smoking for the two weeks before and after implant placement, (9) pregnant or breastfeeding, (10) considered unsuitable to participate in the study by their physician-in-charge, (11) having an experience of the failure of implant placement at the concerned site, (12) undergone tooth extraction within the past 12 weeks.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Makoto Kamo

Organization

Faculty of Dental Science, Kyushu University

Division name

Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

092-642-6441

Email

m_kamo1@dent.kyushu-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yoshihiro Tsukiyama

Organization

Faculty of Dental Science, Kyushu University

Division name

Section of Implant and Rehabilitative Dentistry, Division of Oral Rehabilitation

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

092-642-6441

Homepage URL

Email

tsuki@dent.kyushu-u.ac.jp

Sponsor or person

Institute

Faculty of Dental Science, Kyushu University

Institute

Department

Personal name

Funding Source

Organization

Fukuoka Tenjin Implant Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Faculty of Dental Science, Kyushu University

Name of secondary funder(s)

Kyushu University

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡天神インプラントクリニック（福岡県）

Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 08 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

In this study, we randomly selected PRF or Bio-Oss for simultaneous implant placement with sinus graft and conducted a 9-12month follow-up observation. Our results indicated good outcomes, with a survival rate of 100% in the PRF group and 95.2% in the Bio-Oss group. A stability dip in ISQ values was also noted in both groups at 2 weeks after implant placement. The stability dip was mild in the PRF group and ISQ values were observed to be identical in the two groups at several time-points. Thus, together with the good survival rate achieved, we confirmed the efficacy of PRF. In the future, further follow-up observation of research patients needs to be conducted.

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

2013 Year 08 Month 23 Day

Date of IRB

Anticipated trial start date

2013 Year 09 Month 20 Day

Last follow-up date

Date of closure to data entry

2013 Year 03 Month 31 Day

Date trial data considered complete

Date analysis concluded

2013 Year 03 Month 31 Day

Other

Other related information

Management information

Registered date

2016 Year 03 Month 04 Day

Last modified on

2017 Year 02 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024612

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name