Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

Study Overview
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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

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.

Official Title
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Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions

Conditions
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Periapical Lesion

Intervention / Treatment
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* Procedure: Periapical surgery with guided tissue regeneration
* Procedure: Periapical surgery without anyguided tissue regeneration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periapical surgery with guided tissue regeneration<br>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. | Procedure: Periapical surgery with guided tissue regeneration<br>* periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules<br>|
| Active Comparator: Periapical surgery without any guided tissue regeneration<br>Patients with through and through periapical lesion will undergo periapical surgery and flap closure done. | Procedure: Periapical surgery without anyguided tissue regeneration<br>* periapical surgery will be done followed by flap closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in periapical radiolucency at 12 months | 2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure) scores for 3D healing Score 1 - 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 |
| --- | --- | --- |
| change in Quality of life from baseline to 7 days | caliberated operator will score the quality of life questionnaire in patients following surgical endodontic treatment | postoperative Day 1 to day 7 |