The 3-Dimensional Printed Guide in Endodontic Microsurgery

September 27, 2023 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Success at two weeks
Time Frame: Periodontal tissue healing will be evaluated clinically "2 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
Time Frame: Clinical signs or symptoms will be evaluated "1 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
Time Frame: Periapical tissues healing will be evaluated radiographically at 6 months after surgery

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
Time Frame: Periapical tissues healing will be evaluated radiographically at 12 months after surgery

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
Time Frame: During surgery
The surgical time will be recorded in minutes from the first incision to the last suturing
During surgery
Change in Pain Perception
Time Frame: Pain will be evaluated at 24, 48, and 72 hours after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Rami Kaddoura, DDS,MSc, Damascus university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Endo-01-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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