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The 3-Dimensional Printed Guide in Endodontic Microsurgery

Primary Purpose

Endodontic Disease, Endodontic Re-treatment Failure

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
3-D printed Guide
Conventional Endodontic Micro-Surgery
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease focused on measuring Apicoectomy, Guided Endodontic Surgery, Micro-Surgery, Surgical Guide, 3-Dimensional Printed, Critical Structures

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guided Endodontic Micro-Surgery

Conventional Endodontic Micro-Surgery

Arm Description

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

Free-hand endodontic micro-surgery

Outcomes

Primary Outcome Measures

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.
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.
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
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

Secondary Outcome Measures

Time of surgery
The surgical time will be recorded in minutes from the first incision to the last suturing
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).

Full Information

First Posted
February 27, 2022
Last Updated
September 27, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05283252
Brief Title
The 3-Dimensional Printed Guide in Endodontic Microsurgery
Official Title
Evaluating the Effectiveness of Guided Endodontic Microsurgery in Critical Anatomical Structures (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Endodontic Re-treatment Failure
Keywords
Apicoectomy, Guided Endodontic Surgery, Micro-Surgery, Surgical Guide, 3-Dimensional Printed, Critical Structures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Endodontic Micro-Surgery
Arm Type
Experimental
Arm Description
Use of the 3-D printed guide in endodontic micro-surgery
Arm Title
Conventional Endodontic Micro-Surgery
Arm Type
Placebo Comparator
Arm Description
Free-hand endodontic micro-surgery
Intervention Type
Device
Intervention Name(s)
3-D printed Guide
Intervention Description
Guided Endodontic micro-surgery
Intervention Type
Other
Intervention Name(s)
Conventional Endodontic Micro-Surgery
Intervention Description
Free-hand endodontic micro-surgery
Primary Outcome Measure Information:
Title
Clinical Success at two weeks
Description
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.
Time Frame
Periodontal tissue healing will be evaluated clinically "2 weeks"
Title
Clinical Success at one year
Description
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.
Time Frame
Clinical signs or symptoms will be evaluated "1 year"
Title
Radiographic Success at 6 months
Description
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
Time Frame
Periapical tissues healing will be evaluated radiographically at 6 months after surgery
Title
Radiographic Success at 12 months
Description
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
Time Frame
Periapical tissues healing will be evaluated radiographically at 12 months after surgery
Secondary Outcome Measure Information:
Title
Time of surgery
Description
The surgical time will be recorded in minutes from the first incision to the last suturing
Time Frame
During surgery
Title
Change in Pain Perception
Description
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).
Time Frame
Pain will be evaluated at 24, 48, and 72 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Kaddoura, DDS,MSc
Organizational Affiliation
Damascus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
33548331
Citation
Buniag AG, Pratt AM, Ray JJ. Targeted Endodontic Microsurgery: A Retrospective Outcomes Assessment of 24 Cases. J Endod. 2021 May;47(5):762-769. doi: 10.1016/j.joen.2021.01.007. Epub 2021 Feb 4.
Results Reference
background
PubMed Identifier
34289664
Citation
Lio F, Mampieri G, Mazzetti V, Leggeri A, Arcuri L. Guided endodontic microsurgery in apicoectomy: a review. J Biol Regul Homeost Agents. 2021 May-Jun;35(3 Suppl. 1):47-55. doi: 10.23812/21-3supp1-7.
Results Reference
background
PubMed Identifier
31606146
Citation
Popowicz W, Palatynska-Ulatowska A, Kohli MR. Targeted Endodontic Microsurgery: Computed Tomography-based Guided Stent Approach with Platelet-rich Fibrin Graft: A Report of 2 Cases. J Endod. 2019 Dec;45(12):1535-1542. doi: 10.1016/j.joen.2019.08.012. Epub 2019 Oct 9.
Results Reference
background
PubMed Identifier
31253911
Citation
Monaghan L, Jadun S, Darcey J. Endodontic microsurgery. Part one: diagnosis, patient selection and prognoses. Br Dent J. 2019 Jun;226(12):940-948. doi: 10.1038/s41415-019-0415-3.
Results Reference
background
PubMed Identifier
31861995
Citation
Antal M, Nagy E, Braunitzer G, Frater M, Piffko J. Accuracy and clinical safety of guided root end resection with a trephine: a case series. Head Face Med. 2019 Dec 21;15(1):30. doi: 10.1186/s13005-019-0214-8.
Results Reference
background
PubMed Identifier
29426644
Citation
Giacomino CM, Ray JJ, Wealleans JA. Targeted Endodontic Microsurgery: A Novel Approach to Anatomically Challenging Scenarios Using 3-dimensional-printed Guides and Trephine Burs-A Report of 3 Cases. J Endod. 2018 Apr;44(4):671-677. doi: 10.1016/j.joen.2017.12.019. Epub 2018 Feb 14.
Results Reference
background
PubMed Identifier
28139285
Citation
Strbac GD, Schnappauf A, Giannis K, Moritz A, Ulm C. Guided Modern Endodontic Surgery: A Novel Approach for Guided Osteotomy and Root Resection. J Endod. 2017 Mar;43(3):496-501. doi: 10.1016/j.joen.2016.11.001. Epub 2017 Jan 28.
Results Reference
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The 3-Dimensional Printed Guide in Endodontic Microsurgery

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