PRF and Bone Graft in Endodontic Surgeries

NCT04377698 | Completed Phase 4 DMC

• 1 other identifier: SDC/IRDC/2017/MDS-P/05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical; Infection

Outcome Measures

Primary Outcomes (4)

• Change in radiographic healing of periapical tissue after Apicoectomy

  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

  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

  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

  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

Study Arms (2)

Platelet Rich Fibrin group(PRF)

ACTIVE COMPARATOR

Following apicoectomy PRF gel was prepared and placed in the osseous defect followed by placement of PRF membrane

Biological: Platelet Rich Fibrin

Freezed Dried Bone Allograft group(FDBA)

ACTIVE COMPARATOR

Following apicoectomy FDBA graft were prepared and placed in the osseous defect followed by placement of PRF membrane

Biological: FDBA

Interventions

Platelet Rich Fibrin BIOLOGICAL

regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.

Platelet Rich Fibrin group(PRF)

FDBA BIOLOGICAL

regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.

Freezed Dried Bone Allograft group(FDBA)

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saraswati Dental College: lead

Study Sites (1)

Madhur Garg

Lucknow, Uttar Pradesh, 227105, India

Location

MeSH Terms

Conditions

Infections

Study Officials

• Madhur Garg

  Saraswati Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: January 24, 2018
• Primary Completion: November 6, 2019
• Study Completion: December 9, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)