The 3-Dimensional Printed Guide in Endodontic Microsurgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-06-15

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.

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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.

Conditions

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Endodontic Disease Endodontic Re-treatment Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double-Blind

Study Groups

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Guided Endodontic Micro-Surgery

Use of the 3-D printed guide in endodontic micro-surgery

Group Type EXPERIMENTAL

3-D printed Guide

Intervention Type DEVICE

Guided Endodontic micro-surgery

Conventional Endodontic Micro-Surgery

Free-hand endodontic micro-surgery

Group Type PLACEBO_COMPARATOR

Conventional Endodontic Micro-Surgery

Intervention Type OTHER

Free-hand endodontic micro-surgery

Interventions

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3-D printed Guide

Guided Endodontic micro-surgery

Intervention Type DEVICE

Conventional Endodontic Micro-Surgery

Free-hand endodontic micro-surgery

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes