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

Study Overview
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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.

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.

Official Title
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A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial

Conditions
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Chronic Apical Periodontitis

Intervention / Treatment
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* Procedure: Periapical surgery using autologous platelet aggregate
* Procedure: Periapical surgery without autologous platelet aggregate


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Periapical surgery with PRF group<br>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<br>* PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning<br>|
| Placebo Comparator: Control group without PRF<br>Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate. | Procedure: Periapical surgery without autologous platelet aggregate<br>* Flap will be repositioned following apicoectomy directly without placing any platelet aggregate<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apicomarginal defects, Cone Beam Computed Tomography, Autologous platelet aggregate