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Guided Versus Conventional Periapical Endodontic Surgery

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ClinicalTrials.gov Identifier: NCT04133181
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
ahmed meneisy, Cairo University

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

Condition or disease Intervention/treatment Phase
Endodontic Disease Endodontic Re-treatment Failure Device: 3D guide Device: Mock guide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Success of Guided Versus Conventional Periapical Endodontic Surgery: A Randomized Controlled Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Guided endodontic surgery
Use of a 3D surgical guide in endodontic surgery
Device: 3D guide
Use of a 3D guide in endodontic surgery

Placebo Comparator: Conventional endodontic surgery
Use of a mock guide in endodontic surgery
Device: Mock guide
Use of a mock guide in endodontic surgery




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Time of surgery [ Time Frame: During surgery ]
    Recording the surgical time in minutes.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133181


Contacts
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Contact: Ahmed M Meneisy, Master Degree +201008143026 Ahmed.meneisy@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: ahmed meneisy, Doctor Degree candidate, Cairo University
ClinicalTrials.gov Identifier: NCT04133181     History of Changes
Other Study ID Numbers: Endosurgery
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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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
Keywords provided by ahmed meneisy, Cairo University:
Endodontic surgery
Guided surgery
3D guide
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases