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PRF and Bone Graft in Endodontic Surgeries

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ClinicalTrials.gov Identifier: NCT04377698
Recruitment Status : Completed
First Posted : May 6, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Madhur Garg, Saraswati Dental College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periapical; Infection Biological: Platelet Rich Fibrin Biological: FDBA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 'A Comparison of Platelet Rich Fibrin & Mineralised Freezed Dried Bone Allograft to Radiographically Evaluate Healing Post Endodontic Surgery'- an In-vivo Study
Actual Study Start Date : January 24, 2018
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : December 9, 2019

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
Biological: Platelet Rich Fibrin
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
Biological: FDBA
regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377698


Locations
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India
Madhur Garg
Lucknow, Uttar Pradesh, India, 227105
Sponsors and Collaborators
Saraswati Dental College
Investigators
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Principal Investigator: Madhur Garg Saraswati Dental College
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Responsible Party: Madhur Garg, Principal Investigator, Saraswati Dental College
ClinicalTrials.gov Identifier: NCT04377698    
Other Study ID Numbers: SDC/IRDC/2017/MDS-P/05
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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