PRF and Bone Graft in Endodontic Surgeries

May 21, 2020 updated by: Madhur Garg, Saraswati Dental College

'A Comparison of Platelet Rich Fibrin & Mineralised Freezed Dried Bone Allograft to Radiographically Evaluate Healing Post Endodontic Surgery'- an In-vivo Study

AIM: The aim of this study was to compare and evaluate the radiographic healing in patients undergoing apical surgery, using Freeze dried mineralized bone allograft and Platelet-rich Fibrin. OBJECTIVES: To evaluate radiographic healing after periapical surgery using Freeze dried mineralized bone allograft. To evaluate radiographic healing after periapical surgery using Platelet rich Fibrin. To compare the radiographic healing after periapical surgery using Freeze dried mineralized bone allograft and Platelet rich Fibrin. Method: Patients were selected(according to the inclusion criteria) and randomly allocated to PRF and Bone Graft groups.Following apicoectomy PRF gel and FDBA graft were prepared and placed in the osseous defect followed by placement of PRF membrane for graft stabilization and flap closure. Radiographic follow up was done at 1st, 3rd, 6th and 12th months for evaluation of healing using Molven Criteria.

Study Overview

Status

Completed

Detailed Description

The present study will be carried out to compare the post surgical healing of Platelet Rich Fibrin (PRF) & Mineralised freeze-dried bone allograft (FDBA) in the Department of Conservative Dentistry & Endodontics at Saraswati Dental College, Lucknow. The study will be commenced only after due permission and clearance from the Institutional Review Board and Ethical Committee.

Cases will be selected according to the inclusion criteria after obtaining informed consent from the parents. Patients will be diagnosed based on clinical signs & symptoms, intraoral & radiographic findings. A routine medical history followed by blood investigations will be part of the surgical protocol.

After meeting the above criteria the patients will be randomly assigned to either PRF group (Group-A) or Mineralised FDBA group (Group-B) After successful administration of Local Anaesthesia the surgical procedure will be carried out that will include reflection of a full thickness mucoperiosteal flap by sulcular incision and two relieving vertical incisions. Debridement of tissues at the defect site will be done followed by irrigation with sterile saline solution.

In Group-A patients :- 10ml of venous blood will be drawn from the patients by using a 18 gauge needle after selecting a suitable site for venipuncture. Blood will be collected in tubes without anticoagulant and immediately centrifuged at 3,000 rpm for 10min which will result in a fibrin clot containing the platelets located in the middle of the tube, between a layer of red blood cells at the bottom and acellular plasma at the top. This clot will be removed from the tube and the attached red blood cells will be scraped off and discarded.

PRF will be placed into the defect site and wound closure will be performed using appropriate sutures.

In Group-B patients :- Graft material i.e., Mineralised freeze-dried bone allograft (obtained from Tissue Bank, Tata Memorial Hospital) will be mixed with sterile saline solution, followed by careful placement into the defect site.

The flap will be then re-placed to its original position and sutured with appropriate sutures to ensure complete soft tissue coverage of the graft site.

Sutures will be removed after 7 days post-operatively. The cases will be followed up with clinical and radiographic examination and will be recalled at intervals of 3,6, and 9 months to assess the periapical area.

*Any changes in the plan of study will be made as in when necessary following which suitable statistical analysis will be used to analyse the result.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

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

    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 227105
        • Madhur Garg

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

19 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult teeth with failed conventional endodontic therapy and a need for periapical root end surgery.
  • Teeth with bony defect confined to periapical area.
  • Adult individuals presenting a tooth with persisting periapical radiolucency.
  • Adult individuals presenting a tooth with persistent fistula.
  • Adult individuals presenting a tooth with persisting symptoms after orthograde re-treatment.

Exclusion Criteria:

• Patients with severe systemic disorder (i.e. uncontrolled diabetes, immunologic diseases, malignancy), thrombocytopenia or insufficient compliance.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet Rich Fibrin group(PRF)
Following apicoectomy PRF gel was prepared and placed in the osseous defect followed by placement of PRF membrane
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
Active Comparator: Freezed Dried Bone Allograft group(FDBA)
Following apicoectomy FDBA graft were prepared and placed in the osseous defect followed by placement of PRF membrane
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in radiographic healing of periapical tissue after Apicoectomy
Time Frame: Change from Baseline radiographic score at 1 month
Two endodontists extraneous to the present study evaluated the radiographs post intervention and scored the healing according to Molven's scoring criteria for radiographic healing where 0 is representative of unsatisfactory healing and 3- complete healing
Change from Baseline radiographic score at 1 month
Change in radiographic healing of periapical tissue after Apicoectomy
Time Frame: Change from Baseline radiographic score at 3 months
Two endodontists extraneous to the present study evaluated the radiographs post intervention and scored the healing according to Molven's scoring criteria for radiographic healing where 0 is representative of unsatisfactory healing and 3- complete healing
Change from Baseline radiographic score at 3 months
Change in radiographic healing of periapical tissue after Apicoectomy
Time Frame: Change from Baseline radiographic score at 6 months
Two endodontists extraneous to the present study evaluated the radiographs post intervention and scored the healing according to Molven's scoring criteria for radiographic healing where 0 is representative of unsatisfactory healing and 3- complete healing
Change from Baseline radiographic score at 6 months
Change in radiographic healing of periapical tissue after Apicoectomy
Time Frame: Change from Baseline radiographic score at 12 months
Two endodontists extraneous to the present study evaluated the radiographs post intervention and scored the healing according to Molven's scoring criteria for radiographic healing where 0 is representative of unsatisfactory healing and 3- complete healing
Change from Baseline radiographic score at 12 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Madhur Garg, Saraswati Dental College

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)

January 24, 2018

Primary Completion (Actual)

November 6, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

May 4, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SDC/IRDC/2017/MDS-P/05

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

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Periapical; Infection

Clinical Trials on Platelet Rich Fibrin

3
Subscribe