Guided Versus Conventional Periapical Endodontic Surgery

Not Applicable

• Conditions: Endodontic Re-treatment Failure; Endodontic Disease
• Interventions: Device: 3D guide; Device: Mock guide

• Registration Number: NCT04133181
• Lead Sponsor: Cairo University

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-22
• Study Start: 2019-12
• Primary Completion: 2021-04
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided endodontic surgery	3D guide	Use of a 3D surgical guide in endodontic surgery
Conventional endodontic surgery	Mock guide	Use of a mock guide in endodontic surgery

Primary Outcome Measures

Name	Time	Method
Clinical success	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
Radio graphic Success	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

Name	Time	Method
Time of surgery	During surgery	Recording the surgical time in minutes.