UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027743
Receipt number R000031729
Scientific Title Effect of Autogenous Cortical Bone Particulate in Conjunction With Fibroblast Growth Factor in the Treatment of Periodontal Intraosseous Defects
Date of disclosure of the study information 2017/06/13
Last modified on 2022/06/21 19:36:54

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Basic information

Public title

Effect of Autogenous Cortical Bone Particulate in Conjunction With Fibroblast Growth Factor in the Treatment of Periodontal Intraosseous Defects

Acronym

Autogenous Bone Graft and FGF Versus FGF Versus ABG in Intraosseous Defects

Scientific Title

Effect of Autogenous Cortical Bone Particulate in Conjunction With Fibroblast Growth Factor in the Treatment of Periodontal Intraosseous Defects

Scientific Title:Acronym

Autogenous Bone Graft and FGF Versus FGF Versus ABG in Intraosseous Defects

Region

Japan


Condition

Condition

Periodontal Desease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to assess the additional clinical benefit of autogenous bone graft(ABG) when added to fibroblast growth factor (FGF), compared to FGF alone,compared to ABG alone in the treatment of deep periodontal intraosseous defects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

perform clinical attachment level (position of bottom of pocket from cement-enamel junction) at 3 months, 6 months, 12 months after surgery with preoperative baseline

Key secondary outcomes

Gingival Index(GI), Plaque Index(PI), Bleeding on probing(BOP), Probing Pocket Depth(PPD), gingival Recession(REC are performed at before surgery, 3 months, 6 months, 12 months after surgery. X-ray examination is carried out at pre-operation, 3 months, 6 months, 12 months after surgery with simple X-ray standard photography using silicon putty.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

After local anesthesia, buccal and lingual sulcular incisions were made and mucoperiosteal flaps were elevated. Flap design in the interdental area consisted of one of the following alternatives.1) sulcular incisions with the split of buccal and lingual papilla. 2) incision with the preservation of the buccal papilla, according to the simplified papilla preservation technique. Selection of flap design was based on: width of the interdental space, evaluated as the distance from the CEJ of the tooth presenting the bone defect to the CEJ of the adjacent tooth; distance from the contact point or area to the bone crest, as radiographically assessed; apico coronal width of interdental keratinized tissue in the area of intraosseous defect. Vertical incisions were placed mesial or distal to the treated defect, if they were considered necessary for better access or primary closure of the surgical wound.
After flap reflection, all soft tissue was removed from the defect, and the root surface was scaled and planed with hand and ultrasonic instruments.
For the FGF plus ABG group, an adequate amount of cortical bone particulate is harvested from the buccal cortical plate by means of a bone scraper. A first layer of FGF was injected to condition the bone defect and the more apical portion of the root surface. ABG was positioned to fill only the intrabony component of the defect, avoiding any packing of the graft. Finally, a second layer of FGF was injected to cover the grafted autogenous bone particles and to condition the portion of the root surface coronal to the bone crest. Therefore, a sandwich technique was adopted to treat the defect.
Finally, flaps were positioned at the presurgery level or slightly coronal to achieve primary closure of the interdental area without any tension.

Interventions/Control_2

For the FGF alone group, root surface and surrounding bony walls were FGF gel according to the manufacturer instruction.

Interventions/Control_3

For the ABG alone group, autogenous cortical bone particulate was positioned to fill only the intrabony component of the defect.

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

kanagawa dental university yokohama clinic that meets the following criteria out of 20 years of age diagnosed as chronic periodontitis or aggressive periodontitis
A)patient with periodontal pocket of more than 6mm in the retest after basic periodontal treatment and 4mm or more in the bone defect in the intra oral X ray examination
B)patient without diabetes, smoking, heart disease, pregnancy, or oral malignancy
C)prior to periodontal surgery plaque control and bleeding on probing is less than 20%

Key exclusion criteria

D)third molar teeth, degree of mobility 3, furcation involvement lesion only, incompatible repair and prosthesis, inappropriate root canal treatment teeth. patients who judged inappropriate by the responsible doctor.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name yohei
Middle name
Last name kamata

Organization

kanagawa dental university yokohama clinic

Division name

department of highly advanced stomatology

Zip code

221-0835

Address

3-31-6 tsuruyacho kanagawa word yokohama city

TEL

045-313-0007

Email

kamata@kdu.ac.jp


Public contact

Name of contact person

1st name yohei
Middle name
Last name kamata

Organization

kanagawa dental university yokohama clinic

Division name

department of highly advanced stomatology

Zip code

221-0835

Address

3-31-6 tsuruyacho kanagawa word yokohama city

TEL

045-313-0007

Homepage URL


Email

kamata@kdu.ac.jp


Sponsor or person

Institute

kanagawa dental university yokohama clinic

Institute

Department

Personal name



Funding Source

Organization

kanagawa dental university yokohama clinic

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethics committees of Kanagawa Dental University

Address

82 Inaoka-cho, Yokosuka, Kanagawa

Tel

046-822-8813

Email

gakuchou@kdu.ac.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 13 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

60

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

No longer recruiting

Date of protocol fixation

2017 Year 04 Month 28 Day

Date of IRB

2017 Year 04 Month 28 Day

Anticipated trial start date

2017 Year 06 Month 13 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 05 Month 31 Day

Date trial data considered complete

2022 Year 12 Month 31 Day

Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 06 Month 13 Day

Last modified on

2022 Year 06 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031729


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name