The 3-Dimensional Printed Guide in Endodontic Microsurgery

NCT05283252 | Completed

• 1 other identifier: UDDS-Endo-01-2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease; Endodontic Re-treatment Failure

Keywords

Apicoectomy; Guided Endodontic Surgery; Micro-Surgery; Surgical Guide; 3-Dimensional Printed; Critical Structures

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Time of surgery

  During surgery

• Change in Pain Perception

  Pain will be evaluated at 24, 48, and 72 hours after surgery

Study Arms (2)

Guided Endodontic Micro-Surgery

EXPERIMENTAL

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

Device: 3-D printed Guide

Conventional Endodontic Micro-Surgery

PLACEBO COMPARATOR

Free-hand endodontic micro-surgery

Other: Conventional Endodontic Micro-Surgery

Interventions

3-D printed Guide DEVICE

Guided Endodontic micro-surgery

Guided Endodontic Micro-Surgery

Conventional Endodontic Micro-Surgery OTHER

Free-hand endodontic micro-surgery

Conventional Endodontic Micro-Surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (7)

• 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.

  PMID: 33548331 BACKGROUND

• 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.

  PMID: 34289664 BACKGROUND

• 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.

  PMID: 31606146 BACKGROUND

• 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.

  PMID: 31253911 BACKGROUND

• 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.

  PMID: 31861995 BACKGROUND

• 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.

  PMID: 29426644 BACKGROUND

• 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.

  PMID: 28139285 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rami Kaddoura, DDS,MSc

  Damascus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 16, 2022
• Study Start: April 15, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

SY (1)