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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double

Study Groups

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Periapical surgery with PRF group

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

Group Type ACTIVE_COMPARATOR

Periapical surgery using autologous platelet aggregate

Intervention Type PROCEDURE

PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning

Control group without PRF

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

Group Type PLACEBO_COMPARATOR

Periapical surgery without autologous platelet aggregate

Intervention Type PROCEDURE

Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

Interventions

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Periapical surgery using autologous platelet aggregate

PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning

Intervention Type PROCEDURE

Periapical surgery without autologous platelet aggregate

Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes