Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery

Study Overview
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Brief Summary
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This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.

Detailed Description
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The goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. Piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.In this study after thorough clinical & radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. Patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with US6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. Each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. They will be also requested to note down the details of analgesic intake. Hemorrhage control during surgery will be assesed. Clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative CBCT taken to evaluate volume reduction of lesion postoperatively.

Official Title
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Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery : A Randomized Clinical Trial

Conditions
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Periapical Disease

Intervention / Treatment
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* Procedure: piezoelectric surgery
* Procedure: conventional bur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2). Patients of age 16 years and above. The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis). The nonsurgical re-treatment was judged unfeasible or had previously failed. The tooth had an adequate final restoration with no clinical evidence of coronal leakage. The apical area of the root canal should be devoid of the presence of a post for at least 6 mm. Patients with no acute symptoms. Exclusion Criteria: Unrestorable tooth. Fractured / perforated tooth. Apicomarginal defects. Through & through lesions. Teeth with deep pockets. Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: periapical surgery with piezo.<br>After flap reflection bone and root end cutting are done with US6 piezoelectric surgical insert | Procedure: piezoelectric surgery<br>* after flap reflection bone and root end cutting are done with piezoelectric surgical insert<br>|
| Active Comparator: Periapical surgery with bur.<br>After flap reflection bone and root end cutting are done with surgical bur. | Procedure: conventional bur<br>* after flap reflection bone and root end cutting are done with surgical bur<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment | By quality of life questionnaire(Igor Tsesis et al) | Till 1 week after surgery | 
| Postoperative healing | 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D criteria | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhage control | assessed by scores used by Vy et al | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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piezoelectric surgery, quality of life, hemostasis