A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates

A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial

This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.

Study Overview

Detailed Description

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.

Study Type

Interventional

Enrollment (Anticipated)

32

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 Contact

Study Locations

    • Haryana
      • Rohtak, Haryana, India, 124001
        • Recruiting
        • Ankita Ramani
        • Contact:
          • ANKITA RAMANI
          • Phone Number: 9582841539

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
  • Apicomarginal communication having probing depth > 6mm.
  • Patients with no general medical contraindications for oral surgical procedures.
  • Recurrent episodes of purulent discharge.
  • Failed previous root canal treatment.
  • Failed previous surgery with persistent bony lesion.
  • Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

  • Clinical or radiographic evidence of root fracture.
  • Resorptive processes involving more than apical third of the root.
  • Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy.
  • Any condition effecting rate of healing like smoking.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Periapical surgery with PRF group
Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
Placebo Comparator: Control group without PRF
Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in periapical radiolucency
Time Frame: Baseline to 12 Months

2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring

scores for 2D healing

Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing

scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing

Baseline to 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: Baseline to 12 Months
Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion
Baseline to 12 Months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: ANKITA RAMANI, Post graduate institute of dental sciences, Rohtak

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)

July 1, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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