UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035816 |
|---|---|
| Receipt number | R000040747 |
| Scientific Title | Comparative clinical & radiographic evaluation to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone levels-A randomized clinical trial |
| Date of disclosure of the study information | 2019/02/08 |
| Last modified on | 2019/02/08 18:55:08 |
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Basic information
Public title
Comparative clinical & radiographic evaluation
to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone
levels-A randomized clinical trial
Acronym
EFFECT OF PLATELET RICH FIBRIN ON PERI IMPLANT WOUND HEALING AND CRESTAL BONE LEVELS
Scientific Title
Comparative clinical & radiographic evaluation
to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone
levels-A randomized clinical trial
Scientific Title:Acronym
EFFECT OF PLATELET RICH FIBRIN ON PERI IMPLANT WOUND HEALING AND CRESTAL BONE LEVELS
Region
| Asia(except Japan) |
Condition
Condition
partially edentulous patient in mandibular posterior region
Classification by specialty
| Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the crestal bone levels at mesial & distal aspects of dental implants placed along with platelet rich fibrin . To evaluate soft tissue healing following implants placed along with autologous platelet rich fibrin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Wound Healing Index (WHI) was recorded at baseline and after
second stage surgery that is at 3 months. Marginal Bone Levels (MBL) was assessed at baseline and re
evaluated and 6 months
Key secondary outcomes
Ancillary parameters included Plaque index (PI),Bleeding Index
(BI),Pocket probing depth (PPD),Peri-implant attachment level (PAL).These were
recorded after placement of healing abutments at 3 and 6 months postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
implant with platelet rich fibrin
Interventions/Control_2
implant without platelet rich fibrin
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with adequate bone width, height & density to recieve an implant
2.Male and female patients belonging to age group 20 to 55years.
3.Systemically healthy patients.
4.patients with healthy periodontal status & bilaterally symmetrical occlusion.
Key exclusion criteria
1.Patients with conditions like Diabetes, hypertension, atherosclerosis and other systemic
diseases known to affect periodontal status.
2.Pregnant and Lactating Women.
3.Patients with deleterious habits like alcohol consumption , tobacco habits,smoking and any
other adverse habits.
4 Patients who have received any surgical or non surgical periodontal therapy in past 6
months.
5.Patients who have received any antimicrobial therapy in past 3 months.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aakriti Sharma |
Organization
ITS Dental college,Hospital and Research centre,Greater Noida.
Division name
department of periodontics & implantology
Zip code
Address
47 Knowledge park III,greater noida, Uttar Pradesh,India
TEL
91-9811533651
aakriti8911@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aakriti Sharma |
Organization
ITS Dental college,Hospital and research centre,Greater Noida
Division name
department of periodontics & implantology
Zip code
Address
47 knowledge park III,greater noida,Uttar Pradesh ,India
TEL
91-9811533651
Homepage URL
aakriti8911@gmail.com
Sponsor or person
Institute
self founding
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
ITS dental college,hospital and research centre ,greater noida,uttar pradesh
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
Results of the study revealed improvement in all clinical parameters from baseline to 6 months
but no significant differences were observed in terms of wound healing undex, pocket probing depth and perimplant attachment levels. Ancillary parameters
like plaque index and bleeding index also showed significant improvements from baseline values.
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
| 2016 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 07 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 07 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 30 | Day |
Other
Other related information
Based on the inferences drawn from the present study it can be concluded that within the
limitations of this study, Platelet Rich Fibrin placed along with implants offers advantages for
patient comfort and accelerates the initial healing process. It allows better soft tissue maintenance and
favorable optimal bone regeneration.
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040747
