The 3-Dimensional Printed Guide in Endodontic Microsurgery

Study Overview
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Brief Summary
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In recent years, there was a great interest in employing the surgical guide in dentistry due to the development occurred in the 3D printing which became available widely. Cone beam computed tomography (CBCT) is necessary and crucial in planning for endodontic surgery, but the procedure still depends on how the surgeon reflect the 3D images on the anatomical structures accurately, which may leave room for error. This study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures.

Detailed Description
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Endodontic microsurgery in critical anatomical structures is considered as a serious challenge for the endodontist. Major advances have been made to the techniques used in endodontic surgery to make the procedure easier to perform, safer and more predictable. Several case reports that used surgical guide in endodontic microsurgery found that the procedure was more accurate in control of depth, diameter and angle of osteotomy. The aim of this study is to compare the clinical and radiographic outcomes using guided endodontic microsurgery versus conventional endodontic microsurgery in critical anatomical structures. Patients will be selected that they are indicated for endodontic surgery. Upper and lower teeth will be selected close to critical anatomy such as; maxillary sinus, nasal fossa, mental foramen and mandibular canal. medical and dental history will be obtained from all selected patients. Patients will be randomly distributed to either guided micro-surgery group or conventional micro-surgery group. All steps of the surgical procedure will be performed under microscopic magnification. Bioceramic putty will be used as a root-end filling material. Post-surgical instructions will be given to patients. The time of the surgery will be recorded from the first incision to the last suturing. Success and failure will be assessed using radiographic and clinical evaluation at 6 and 12 months.

Official Title
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Evaluating the Effectiveness of Guided Endodontic Microsurgery in Critical Anatomical Structures (A Randomized Clinical Trial)

Conditions
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Endodontic Disease, Endodontic Re-treatment Failure

Intervention / Treatment
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* Device: 3-D printed Guide
* Other: Conventional Endodontic Micro-Surgery


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. Posterior/anterior teeth close to critical anatomical structures that indicated for endodontic surgery. Patients' acceptance to participate in the trail. Exclusion Criteria: Patients with allergy to materials or medications used in the trial. Patients with Serious systemic disease incompatible with surgery. Pregnant female patients. Teeth with periapical pathosis associated with vertical root fracture. Non-restorable teeth. Teeth with periodontal probe more than 5 mm.

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
Interventional Model Description: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Endodontic Micro-Surgery<br>Use of the 3-D printed guide in endodontic micro-surgery | Device: 3-D printed Guide<br>* Guided Endodontic micro-surgery<br>|
| Placebo Comparator: Conventional Endodontic Micro-Surgery<br>Free-hand endodontic micro-surgery | Other: Conventional Endodontic Micro-Surgery<br>* Free-hand endodontic micro-surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success at two weeks | The position of the oral mucosa at the flap site will be assessed after surgery to evaluate wound healing using the wound healing index (WHI) by Huang et al 2005 as the following criteria: Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration. Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration. | Periodontal tissue healing will be evaluated clinically 2 weeks | 
| Clinical Success at one year | The patient's symptoms will be evaluated and the examination will be done on percussion, palpation and probing. Clinical Success will be defined as absence of pain, swelling or sensitivity on percussion. Clinical failure is the persistence of any of the above-mentioned symptoms. | Clinical signs or symptoms will be evaluated 1 year | 
| Radiographic Success at 6 months | Early follow-up will be done and the initial radiographic Success or failure will be assessed. The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images | Periapical tissues healing will be evaluated radiographically at 6 months after surgery | 
| Radiographic Success at 12 months | Radiographic Success will be defined as either complete or incomplete healing (formation of scar tissue). Radiographic Failure will involve either uncertain healing (small or constant lesion size) or unsatisfactory healing (increased lesion size). The size of periapical lesions/radiographic transparency will be measured in millimeters by periapical radiographs and CBCT images | Periapical tissues healing will be evaluated radiographically at 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of surgery | The surgical time will be recorded in minutes from the first incision to the last suturing | During surgery | 
| Change in Pain Perception | Pain assessment will be performed using a Visual Analog Scale (VAS) which is a subjective measure instrument for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 (no pain) and 10 (worst pain). | Pain will be evaluated at 24, 48, and 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apicoectomy, Guided Endodontic Surgery, Micro-Surgery, Surgical Guide, 3-Dimensional Printed, Critical Structures