UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053980 |
|---|---|
| Receipt number | R000061622 |
| Scientific Title | Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/28 00:34:07 |
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Basic information
Public title
Bone Morphogenetic Protein-2 Levels in GFF after Hydroxyapatite Tricalcium Phosphate Bone Graft in Vertical Defect, A RCT
Acronym
Bone Morphogenetic Protein-2 Levels in GCF after HA-TCP Bone Graft, a RCT
Scientific Title
Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial
Scientific Title:Acronym
Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial:Bone Morphogenetic Protein-2 Levels in Gingival Crevicular Fluid Following Hydroxyapatite Tricalcium Phosphat Bone Graft in Vertical Defect, A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Periodontitis patient with vertical bone defect and systemically healthy
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effect of applying a new HA-TCP bone graft on BMP-2 levels in regenerative periodontal surgery
Basic objectives2
Others
Basic objectives -Others
increase of BMP-2 levels
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Increase of BMP-2 levels in GCF
Key secondary outcomes
Reduction of periodontal pocket
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Periodontal regenerative surgery in vertical bone defect, the test group received HA-TCP bone graft and membrane
Interventions/Control_2
The control group only received membrane
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria included male or female patients aged of 30 years, having periodontal pocket 6 mm clinically examined using a UNC 15 probe with vertical defects confirmed by radiograph, no inadequate restorations and carious lesions, non-smokers and had gone through the initial phase with a plaque score of 10%.
Key exclusion criteria
Exclusion patients included patients diagnosed with aggressive periodontitis, pregnant and lactating women, wearing orthodontic appliances, taking antibiotics, anti-inflammatory and immunosuppressants for the last three months, and having a history of uncontrolled systemic disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ira |
| Middle name | |
| Last name | Komara |
Organization
Dental Faculty, Universitas Padjadjaran Bandung West Java INDONESIA
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no 1 Bandung
TEL
+62222504985
ira.komara@unpad.ac.id
Public contact
Name of contact person
| 1st name | Ira |
| Middle name | |
| Last name | Komara |
Organization
Dental Faculty Universitas Padjadjaran Indonesia
Division name
Periodontology
Zip code
40132
Address
Jalan Sekeloa Selatan no 1 Bandung
TEL
+62222504985
Homepage URL
ira.komara@unpad.ac.id
Sponsor or person
Institute
Indonesian Agency for the Assessment and Application of Technology and Dental Faculty Universitas Padjadjaran, Indonesia
Institute
Department
Personal name
Dr Dudi Aripin, DDS, Endo.
Funding Source
Organization
BATAN Research Tissue Bank, Indonesia and Universitas Padjadjaran Indonesia
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
INDONESIA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komite Etik Penelitian Universitas Padjadjaran
Address
Jl. Prof. Eijkman No. 38 Bandung
Tel
+62222038697
kep@unpad.ac.id
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
Dental Teaching Hospital Universitas Padjadjaran
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
32
Results
There was an increase in BMP-2 levels in the treatment group.
Results date posted
| 2024 | Year | 03 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Not yet published
Date of the first journal publication of results
Baseline Characteristics
Vertical Bone defect, periodontal pocket of more than 6 mm
Participant flow
32 randomized into 2 groups, Aseptic procedures were performed on the extraoral and intraoral sections and continued with anesthesia.The flap surgical procedure began with an internal bevel incision towards the alveolar crest 0.5-1 mm from the gingival margin following the shape of the gingival margin and followed by a sulcular incision.To improve accessibility, a vertical incision was made to open the flap, then the gingiva was reflected, subsequently the granulation tissue was removed. The necrotic bone was removed, and the functional area was cleaned and dried with sterile tampons. The test group received HA-TCP bone graft and membrane while the control group received only membrane. The flap was then sutured with 4.0 silk thread and a periodontal pack was installed (Coe-Pack, GCAmerica). After one week, periodontal pack and sutures were removed and area of operation was irrigated with saline[10].
Colection of gingival crevicular fluid
Gingival crevicular fluid was taken using a paper strip (Oraflow) which was placed into the gingival sulcus with light pressure for 30 seconds. Subsequently, the paper strip was pulled out and put into a 1.5 mL Eppendorf tube containing 0.5 mL of phosphate buffer saline (PBS).The tubes are labeled and then stored at -80 0C.GCF was taken twice, on day 0 before periodontal surgery and day 14 during post-surgical control.The examination was carried out to see the effect of the application of HA-TCP bone graft on BMP-2 levels in regenerative periodontal surgical treatment using human BMP-2 analysis
Adverse events
no AE
Outcome measures
BMP-2 levels
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061622
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