NCT04650763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 14, 2020

Last Update Submit

November 25, 2020

Conditions

Alveolar Bone LossPlatelet Rich Plasma

Keywords

Dental implant, Cone Beam Computerized Tomography (CBCT).

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measurement of bone loss at baseline (12 weeks) and later at 26weeks

    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 Outcomes (1)

  • Bone Mineral Density

    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

Study Arms (2)

Control Group

NO INTERVENTION

Dental implant was placed in these patients following full protocol of immediate implant placement.

PRP Group

EXPERIMENTAL

In this group Platelet Rich Plasma (PRP) was injected in soft tissue over surgical site.

Biological: PRP injectionDevice: Automated blood cell separator to extract PRP

Interventions

PRP injectionBIOLOGICAL

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.

Also known as: Platelet Rich Plasma injection
PRP Group
Automated blood cell separator to extract PRPDEVICE

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.

Also known as: Automated blood cell separator/ centrifuge
PRP Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients maintaining good oral hygiene, having adequate bone quantity at the implant site, uneventful extraction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dentistry; CMH Lahore Medical College

Lahore, Punjab Province, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 26023636RESULT

  • 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.

    PMID: 33791377DERIVED

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Abdul Mueed Zaigham, BDS; FCPS

    Institute of Dentistry; CMH Lahore Medical College

    STUDY CHAIR

  • Maliha Shahbaz, BDS; MPhil

    Oral Biology Department; Rashid Latif Dental College, Lahore

    STUDY DIRECTOR

  • Usman Zaheer, BDS; FCPS

    Lahore Medical & Dental College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Head Prosthodontics Department

Study Record Dates

First Submitted

November 14, 2020

First Posted

December 3, 2020

Study Start

October 2, 2017

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

December 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)