Back to resultsGuided Versus Conventional Periapical Endodontic Surgery
Primary Purpose
Endodontic Disease, Endodontic Re-treatment Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D guide
Mock guide
Sponsored by
About this trial
This is an interventional treatment trial for Endodontic Disease focused on measuring Endodontic surgery, Guided surgery, 3D guide
Eligibility Criteria
Inclusion Criteria:
- Patients in good general health.
- Patients with age ranging between 18-50 years with no sex predilection.
- Posterior teeth with an indication for endodontic surgery.
- Patients' acceptance to participate in the study.
Exclusion Criteria:
- Patients with allergy to materials or medications used in the trial.
- Pregnant female patients.
- Teeth with pathoses associated with vertical root fracture.
- Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Guided endodontic surgery
Conventional endodontic surgery
Arm Description
Use of a 3D surgical guide in endodontic surgery
Use of a mock guide in endodontic surgery
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Time of surgery
Recording the surgical time in minutes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04133181
Brief Title
Guided Versus Conventional Periapical Endodontic Surgery
Official Title
Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.
Detailed 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.
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
Endodontic surgery, Guided surgery, 3D guide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided endodontic surgery
Arm Type
Experimental
Arm Description
Use of a 3D surgical guide in endodontic surgery
Arm Title
Conventional endodontic surgery
Arm Type
Placebo Comparator
Arm Description
Use of a mock guide in endodontic surgery
Intervention Type
Device
Intervention Name(s)
3D guide
Intervention Description
Use of a 3D guide in endodontic surgery
Intervention Type
Device
Intervention Name(s)
Mock guide
Intervention Description
Use of a mock guide in endodontic surgery
Primary Outcome Measure Information:
Title
Clinical success
Description
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
Time Frame
1 year
Title
Radio graphic Success
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time of surgery
Description
Recording the surgical time in minutes.
Time Frame
During 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 with no sex predilection.
Posterior teeth with an indication for endodontic surgery.
Patients' acceptance to participate in the study.
Exclusion Criteria:
Patients with allergy to materials or medications used in the trial.
Pregnant female patients.
Teeth with pathoses associated with vertical root fracture.
Severe periodontal bone loss detected with a periodontal probe (5 mm probing depth).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Meneisy, Master Degree
Phone
+201008143026
Email
Ahmed.meneisy@dentistry.cu.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
29486052
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.
Results Reference
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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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PubMed Identifier
29358006
Citation
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.
Results Reference
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Guided Versus Conventional Periapical Endodontic Surgery
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