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

Primary Purpose

Chronic Apical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Periapical surgery using autologous platelet aggregate
Periapical surgery without autologous platelet aggregate
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Apical Periodontitis focused on measuring Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ankita RamaniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Periapical surgery with PRF group

Control group without PRF

Arm Description

Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.

Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2020
Last Updated
May 17, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04389346
Brief Title
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates
Official Title
A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Apical Periodontitis
Keywords
Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Periapical surgery with PRF group
Arm Type
Active Comparator
Arm Description
Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.
Arm Title
Control group without PRF
Arm Type
Placebo Comparator
Arm Description
Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.
Intervention Type
Procedure
Intervention Name(s)
Periapical surgery using autologous platelet aggregate
Intervention Description
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
Intervention Type
Procedure
Intervention Name(s)
Periapical surgery without autologous platelet aggregate
Intervention Description
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate
Primary Outcome Measure Information:
Title
Change in periapical radiolucency
Description
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
Time Frame
Baseline to 12 Months
Secondary Outcome Measure Information:
Title
Clinical success
Description
Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion
Time Frame
Baseline to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR PANKAJ SANGWAN
Phone
9996112202
Email
drps_1@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ANKITA RAMANI
Phone
9582841539
Email
ramaniankita95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANKITA RAMANI
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankita Ramani
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANKITA RAMANI
Phone
9582841539

12. IPD Sharing Statement

Learn more about this trial

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

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