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
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
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
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
