Bone Healing in Immediate Dental Implants

November 25, 2020 updated by: Prof. Abdul Mueed Zaigham, CMH Lahore Medical And Dental College

Effect of PRP on Bone Healing in Immediate Implants Analyzed by CBCT

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Institute of Dentistry; CMH Lahore Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Dental implant was placed in these patients following full protocol of immediate implant placement.
Experimental: PRP Group
In this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site.
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.
Other Names:
  • Platelet Rich Plasma injection
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.
Other Names:
  • Automated blood cell separator/ centrifuge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of bone loss at baseline (12 weeks) and later at 26weeks
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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMH Lahore Medical And Dental College

Investigators

  • Principal Investigator: Aleshba Saba khan, BDS; FCPS, Institute of Dentistry; CMH Lahore Medical College
  • Principal Investigator: Naauman Zaheer, BDS; PhD, Institute of Dentistry; CMH Lahore Medical College
  • Study Chair: Abdul Mueed Zaigham, BDS; FCPS, Institute of Dentistry; CMH Lahore Medical College
  • Study Director: Maliha Shahbaz, BDS; MPhil, Oral Biology Department; Rashid Latif Dental College, Lahore
  • Principal Investigator: Usman Zaheer, BDS; FCPS, Lahore Medical & Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

November 14, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Case # 466/ERC/CMH/LMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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