UMIN-CTR 臨床試験登録情報の閲覧

Basic information
Official scientific title of the study	Comparative clinical & radiographic evaluation to assess the effect of platelet rich fibrin on peri implant wound healing & crestal bone levels-A randomized clinical trial
Title of the study (Brief title)	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	Aakriti Sharma
Organization	ITS Dental college,Hospital and Research centre,Greater Noida.
Division name	department of periodontics & implantology
Address	47 Knowledge park III,greater noida, Uttar Pradesh,India
TEL	91-9811533651
Email	aakriti8911@gmail.com

Public contact
Name of contact person	Aakriti Sharma
Organization	ITS Dental college,Hospital and research centre,Greater Noida
Division name	department of periodontics & implantology
Address	47 knowledge park III,greater noida,Uttar Pradesh ,India
TEL	91-9811533651
Homepage URL
Email	aakriti8911@gmail.com

Sponsor
Institute	self founding
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040747