Clinical trial NCT05283252: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Disease
Endodontic Re-treatment Failure
Keywords: Apicoectomy
Guided Endodontic Surgery
Micro-Surgery
Surgical Guide
3-Dimensional Printed
Critical Structures
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Success at two weeks
timeFrame: Periodontal tissue healing will be evaluated clinically "2 weeks"
measure: Clinical Success at one year
timeFrame: Clinical signs or symptoms will be evaluated "1 year"
measure: Radiographic Success at 6 months
timeFrame: Periapical tissues healing will be evaluated radiographically at 6 months after surgery
measure: Radiographic Success at 12 months
timeFrame: Periapical tissues healing will be evaluated radiographically at 12 months after surgery
Secondary outcomes:
measure: Time of surgery
timeFrame: During surgery
measure: Change in Pain Perception
timeFrame: Pain will be evaluated at 24, 48, and 72 hours after surgery
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Damascus University
name: Rami Kaddoura, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.