Back to resultsBone Healing in Immediate Dental Implants
Primary Purpose
Alveolar Bone Loss, Platelet Rich Plasma
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
PRP injection
Automated blood cell separator to extract PRP
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Dental implant, Cone Beam Computerized Tomography (CBCT).
Eligibility Criteria
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
Sites / Locations
- Institute of Dentistry; CMH Lahore Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
PRP Group
Arm Description
Dental implant was placed in these patients following full protocol of immediate implant placement.
In this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site.
Outcomes
Primary Outcome Measures
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Measurement at mesial in mm
Secondary Outcome Measures
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Measurement at distal in mm
Full Information
NCT ID
NCT04650763
First Posted
November 14, 2020
Last Updated
November 25, 2020
Sponsor
CMH Lahore Medical And Dental College
1. Study Identification
Unique Protocol Identification Number
NCT04650763
Brief Title
Bone Healing in Immediate Dental Implants
Official Title
Effect of PRP on Bone Healing in Immediate Implants Analyzed by CBCT
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CMH Lahore Medical And Dental College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the effect of platelet-rich plasma concentrate on marginal bone loss and bone mineral density in immediate implant placement through CBCT.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Platelet Rich Plasma
Keywords
Dental implant, Cone Beam Computerized Tomography (CBCT).
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Dental implant was placed in these patients following full protocol of immediate implant placement.
Arm Title
PRP Group
Arm Type
Experimental
Arm Description
In this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site.
Intervention Type
Biological
Intervention Name(s)
PRP injection
Other Intervention Name(s)
Platelet Rich Plasma injection
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Automated blood cell separator to extract PRP
Other Intervention Name(s)
Automated blood cell separator/ centrifuge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Description
Measurement at mesial in mm
Time Frame
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 Outcome Measure Information:
Title
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
Description
Measurement at distal in mm
Time Frame
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
Other Pre-specified Outcome Measures:
Title
Bone Mineral Density
Description
Measurement in Hounsfield number
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleshba Saba khan, BDS; FCPS
Organizational Affiliation
Institute of Dentistry; CMH Lahore Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naauman Zaheer, BDS; PhD
Organizational Affiliation
Institute of Dentistry; CMH Lahore Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdul Mueed Zaigham, BDS; FCPS
Organizational Affiliation
Institute of Dentistry; CMH Lahore Medical College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maliha Shahbaz, BDS; MPhil
Organizational Affiliation
Oral Biology Department; Rashid Latif Dental College, Lahore
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Usman Zaheer, BDS; FCPS
Organizational Affiliation
Lahore Medical & Dental College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dentistry; CMH Lahore Medical College
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26023636
Citation
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 2015 Apr 1.
Results Reference
result
PubMed Identifier
33791377
Citation
Khan AS, Zaheer N, Zaigham AM, Shahbaz M, Zaheer U, Alam MK. Effect of Platelet-Rich Plasma on Bone Healing in Immediate Implants Analyzed by Cone Beam Computerized Tomography: A Randomized Controlled Trial. Biomed Res Int. 2021 Mar 13;2021:6685991. doi: 10.1155/2021/6685991. eCollection 2021.
Results Reference
derived
Learn more about this trial
Bone Healing in Immediate Dental Implants
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