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

• Status: Unknown
• Conditions: Chronic Apical Periodontitis
• Intervention / Treatment: Procedure: Periapical surgery using autologous platelet aggregate; Procedure: Periapical surgery without autologous platelet aggregate

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Procedure: Periapical surgery using autologous platelet aggregate; 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.	Procedure: Periapical surgery without 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	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	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

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: ANKITA RAMANI, Post Graduate Institute Of Dental Sciences, Rohtak

Study record dates

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

• Keywords: Cone Beam Computed Tomography; Apicomarginal defects; Autologous platelet aggregate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: Ankita Ramani

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No