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Clinical Trials/NCT04133181
NCT04133181UnknownNot Applicable

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

Cairo University0 sites26 target enrollmentStarted: December 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
26
Primary Endpoint
Radio graphic Success

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

Guided endodontic surgery

Experimental

Use of a 3D surgical guide in endodontic surgery

Intervention: 3D guide (Device)

Conventional endodontic surgery

Placebo Comparator

Use of a mock guide in endodontic surgery

Intervention: Mock guide (Device)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • Time of surgery(During surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ahmed meneisy

Doctor Degree candidate

Cairo University

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