Guided Versus Conventional Periapical Endodontic Surgery

Study Overview
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Brief Summary
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This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.

Detailed Description
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The aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. Patients having mandibular posterior teeth indicated for endodontic surgery will be selected. Full medical and dental history will be obtained from all patients. Patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. Surgical procedures will be done under magnification. Root-end cavities will be filled using MTA.Post surgical instrucions will be given to patients. Surgical time will be recorded. Clinical and radiographic success will be asses at 6 and 12 month.

Official Title
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Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial

Conditions
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Endodontic Disease, Endodontic Re-treatment Failure

Intervention / Treatment
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* Device: 3D guide
* Device: Mock guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in good general health. Patients with age ranging between 18-50 years with no sex predilection. Posterior teeth with an indication for endodontic surgery. Patients' acceptance to participate in the study. Exclusion Criteria: Patients with allergy to materials or medications used in the trial. Pregnant female patients. Teeth with pathoses associated with vertical root fracture. Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided endodontic surgery<br>Use of a 3D surgical guide in endodontic surgery | Device: 3D guide<br>* Use of a 3D guide in endodontic surgery<br>|
| Placebo Comparator: Conventional endodontic surgery<br>Use of a mock guide in endodontic surgery | Device: Mock guide<br>* Use of a mock guide in endodontic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Clinical assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean absence of clinical signs and symptoms, persisting disease mean presence of clinical signs and symptoms | 1 year | 
| Radio graphic Success | Radiograhic assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean radiographic classification of complete healing or incomplete healing, persisting disease mean radiographic classification of unsatisfactory healing. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of surgery | Recording the surgical time in minutes. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontic surgery, Guided surgery, 3D guide