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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04650763
Other study ID # Case # 466/ERC/CMH/LMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2017
Est. completion date March 30, 2018

Study information

Verified date November 2020
Source CMH Lahore Medical And Dental College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT.


Description:

12 subjects were equally categorized into two groups. Group, I was the control group; whereas, the subjects in Group II received Platelet Rich Plasma (PRP) therapy. All subjects were given a standard treatment with single implant system. Inserted implants were analyzed through Cone Beam Computerized Tomography (CBCT). Records were registered at the baseline, at 12th week before functional loading and 26th week after functional loading.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - patients maintaining good oral hygiene, having adequate bone quantity at the implant site, uneventful extraction Exclusion Criteria: - Active infection around implant site, immunocompromised state, with current major systemic disease (uncontrolled diabetes, rheumatoid arthritis, etc.) or oral pathologies, history of bleeding disorders or on anticoagulant therapy, or patients on bisphosphonates were excluded from the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PRP injection
PRP was prepared using patient's blood and mixed with saline or mixture of calcium chloride and thrombin to form a liquid solution; in order to inject at the surgical site after placement of implant.
Device:
Automated blood cell separator to extract PRP
Blood was withdrawn from antecubital vein and mixed with anticoagulant. Blood sample was then centrifuged to obtain platelet rich plasma which was injected at surgical site after implant placement.

Locations

Country Name City State
Pakistan Institute of Dentistry; CMH Lahore Medical College Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
CMH Lahore Medical And Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Boora P, Rathee M, Bhoria M. Effect of Platelet Rich Fibrin (PRF) on Peri-implant Soft Tissue and Crestal Bone in One-Stage Implant Placement: A Randomized Controlled Trial. J Clin Diagn Res. 2015 Apr;9(4):ZC18-21. doi: 10.7860/JCDR/2015/12636.5788. Epub — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Bone Mineral Density Measurement in Hounsfield number Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
Primary Measurement of bone loss at baseline (12 weeks) and later at 26weeks Measurement at mesial in mm Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
Secondary Measurement of bone loss at baseline (12 weeks) and later at 26weeks Measurement at distal in mm Baseline -before functional loading at 12 weeks & at 26 weeks- after functional loading to assess changes in marginal bone loss in sagittal view using CBCT
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