Guided Versus Conventional Periapical Endodontic Surgery

Endodontic Disease Clinical Trial

Official title:

Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04133181
• Other study ID #: Endosurgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: October 2021

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: Ahmed M Meneisy, Master Degree
• Phone: +201008143026
• Email: Ahmed.meneisy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.

Description:

The aim of this study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery. Patients having mandibular posterior teeth indicated for endodontic surgery will be selected. Full medical and dental history will be obtained from all patients. Patients will be randomly assigned to either guided endodontic surgery or conventional endodontic surgery. Surgical procedures will be done under magnification. Root-end cavities will be filled using MTA.Post surgical instrucions will be given to patients. Surgical time will be recorded. Clinical and radiographic success will be asses at 6 and 12 month.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: October 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Patients in good general health.

2. Patients with age ranging between 18-50 years with no sex predilection.

3. Posterior teeth with an indication for endodontic surgery.

4. Patients' acceptance to participate in the study.

Exclusion Criteria:

1. Patients with allergy to materials or medications used in the trial.

2. Pregnant female patients.

3. Teeth with pathoses associated with vertical root fracture.

4. Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Endodontic Re-treatment Failure

Intervention

Device:
• 3D guide
Use of a 3D guide in endodontic surgery
• Mock guide
Use of a mock guide in endodontic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Ahn SY, Kim NH, Kim S, Karabucak B, Kim E. Computer-aided Design/Computer-aided Manufacturing-guided Endodontic Surgery: Guided Osteotomy and Apex Localization in a Mandibular Molar with a Thick Buccal Bone Plate. J Endod. 2018 Apr;44(4):665-670. doi: 10.1016/j.joen.2017.12.009. Epub 2018 Jan 19. — View Citation

Anderson J, Wealleans J, Ray J. Endodontic applications of 3D printing. Int Endod J. 2018 Sep;51(9):1005-1018. doi: 10.1111/iej.12917. Epub 2018 Mar 23. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success	Clinical assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean absence of clinical signs and symptoms, persisting disease mean presence of clinical signs and symptoms	1 year
Primary	Radio graphic Success	Radiograhic assessment using a scale by friedman et al 2005 (healed, healing and persisting disease) which healed mean radiographic classification of complete healing or incomplete healing, persisting disease mean radiographic classification of unsatisfactory healing.	1 year
Secondary	Time of surgery	Recording the surgical time in minutes.	During surgery