- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133181
Guided Versus Conventional Periapical Endodontic Surgery
October 18, 2019 updated by: ahmed meneisy, Cairo University
Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
This study is to compare the clinical and radiographic outcomes after guided periapical endodontic surgery versus conventional endodontic surgery.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed M Meneisy, Master Degree
- Phone Number: +201008143026
- Email: Ahmed.meneisy@dentistry.cu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided endodontic surgery
Use of a 3D surgical guide in endodontic surgery
|
Use of a 3D guide in endodontic surgery
|
Placebo Comparator: Conventional endodontic surgery
Use of a mock guide in endodontic surgery
|
Use of a mock guide in endodontic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success
Time Frame: 1 year
|
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
|
Radio graphic Success
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of surgery
Time Frame: During surgery
|
Recording the surgical time in minutes.
|
During surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2019
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
October 17, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (Actual)
October 21, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 18, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EndoSurgery
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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