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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027743
Receipt No. 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 2017/06/13

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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, 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
Middle name
Last name youhei kamata
Organization kanagawa dental university yokohama clinic
Division name department of highly advanced stomatology
Zip code
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
Middle name
Last name youhei kamata
Organization kanagawa dental university yokohama clinic
Division name department of highly advanced stomatology
Zip code
Address 3-31-6 tsuruyacho kanagawa word yokohama city
TEL 045-313-0007
Homepage URL
Email kamata@kdu.ac.jp

Sponsor
Institute kanagawa dental university yokohama clinic
Institute
Department

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
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

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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2017 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.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


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