Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

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

2019-12-11

Study Completion Date

2021-04-11

Brief Summary

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Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery

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Detailed Description

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Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.

Conditions

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Periapical Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Periapical surgery with guided tissue regeneration

Patients with through and through periapical lesion will undergo periapical surgery and the defect is filled with mixture of iPRF and type 1 collagen granules before flap closure.

Group Type EXPERIMENTAL

Periapical surgery with guided tissue regeneration

Intervention Type PROCEDURE

periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules

Periapical surgery without any guided tissue regeneration

Patients with through and through periapical lesion will undergo periapical surgery and flap closure done.

Group Type ACTIVE_COMPARATOR

Periapical surgery without anyguided tissue regeneration

Intervention Type PROCEDURE

periapical surgery will be done followed by flap closure

Interventions

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Periapical surgery with guided tissue regeneration

periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules

Intervention Type PROCEDURE

Periapical surgery without anyguided tissue regeneration

periapical surgery will be done followed by flap closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients of age 16-55 years with a clinical \& radiographic diagnosis of through and through periradicular lesion using CBCT
* Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
* Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
* The teeth must have adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria

* Unrestorable tooth.
* Fractured / perforated tooth.
* Systemic diseases contraindicating surgical procedures or with potential to affect healing.
* Teeth with deep pockets.
* Patient requiring antibiotic premedication.
* Patients with history of antibiotic use in last 3 months.
* Smokers

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No