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Clinical Trials/NCT06643676
NCT06643676CompletedNot Applicable

Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars : A Randomized Controlled Trial

Postgraduate Institute of Dental Sciences Rohtak1 site in 1 country62 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Quality of life following periapical surgery

Study Overview

Brief Summary

Targeted endodontic microsurgery represents precise and advanced approach to resolving persisting chronic periapical periodontitis after non- surgical root canal treatment. This specialised procedure involves accessing the root tip of the tooth under high magnification using dental operating microscopes and employing microsurgical instruments to remove infected or inflamed tissue, as well as any pathological lesions present in the periapical region. Targeted Endodontic Microsurgery is useful for osteotomy and root- end resection when exacting control of depth, diameter, and angulation of osteotomy and root end resection is necessary. Using a CBCT(cone beam computed tomography) designed 3D - printed surgical guideis a more accurate method for access to the apical portion of the root during surgical endodontics compared with a "freehand" CBCT - approximated conventional method. These guided have the potential to increase accuracy and precision and to reduce intraoperative time as well as postoperative complications. Additionally, it provides a viable treatment option for patients who may not be candidates for traditional root canal therapy or retreatment due to anatomical complexities or previous treatment failures.

Detailed Description

Conventional Endodontic microsurgery takes use of a preoperative scan and manual drilling of the osteotomy site with arbitrary measurements followed by retropreparation and forming the apical seal. One of the most critical disadvantages of conventional root-end resection include the damage to anatomically vital structures such as inferior dental nerve, mental nerve, adjacent root and maxillary sinus. In contrast, endodontic microsurgery using the guide template significantly reduces these damages. Pinsky et al confirmed in their in vitro study that the greater accuracyand consistency was achieved during endodontic surgery with surgical guidance without damaging vital structures. An error greater than 3 mm occurred over 22% of the time with freehand whereas none of errors occurred with surgical guidance.

Consequently, targeted endodontic microsurgery has garnered increasing attention as a viable alternative, offering a refined and precise approach to address such challenges.

Even the most skilled surgeons may find endodontic microsurgery difficult. Some medical professionals steer clear using freehand (FH) Endodontic microsurgery in regions where there is a chance of harming important anatomical features including the maxillary sinus, the mental foramen, and arteries. It is Perceived as complex sites include those with limited access, no direct sight, and areas where the apex is placed distant from the buccal cortical bone without any cortical plate fenestratio. Surgeons may be able to perform precise procedures in difficult-to-reach regions with guided Endodontic Microsurgery

Guided Endodontic Microsurgery is virtually planned on 3D software on the preoperative CBCT scan, and the surgeon executes the osteotomy and root-end resection (RER) under static or dynamic navigation.

Static navigation requires a customized 3D-printed surgical guide (3D-SG) to guide the drilling duringosteotomy and RER. Surgical guides contain a guide template that refers to the 3D location of the virtual Endodontic Microsurgery planned in the CBCT to drill accurately Prior research has demonstrated that 3D-SG can reduce the risk of intra-operative complications whileincreasing the precision and effectiveness of EMS. In comparison to free hand Endodontic Microsurgery, guided Endodontic Microsurgery with 3D-Surgical Guide shortens the surgical time, provides superior control over the resection level and bevel off the root, and enables a tailored osteotomy size.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

participant will be masked by using the autoclaved guides of other patients with the guide tubes cut down and conventional surgery done in control group through the guide.

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients with persistent symptomatic Or asymptomatic apical periodontitis and periapical radiolucency.
  • Previous history of Root canal retreatment.
  • Tooth with a peri-radicular lesion of strictly endodontic origin KIM's Classification A,B,C)
  • Patients between 18-55 years of age.
  • No general medical contraindications for oral surgical procedures (ASA-1) according to the classification of the American Society of Anesthesiologists)
  • ASA 1- A normal healthy patient. Example: Fit, nonobese (BMI under 30), nonsmoking, patient with good exercise tolerance.
  • Tooth with adequate final restoration without clinical evidence of coronal leakage.
  • No spontaneous pain or swelling.
  • Good periodontal health condition at tooth level
  • Able to completely understand and sign an informed consent form

Exclusion Criteria

  • Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders)
  • Patients on anticoagulant/ antiplatelet drugs.
  • Fractured/perforated teeth.
  • Teeth with deep pockets (probing depth > 4 mm).
  • Presence of vertical root fracture.
  • Miller class III/IV mobility.
  • Pregnancy.
  • second mandibular molars

Arms & Interventions

Conventional Endodontic microsurgery using burs

Active Comparator

Conventional Endodontic microsurgery using carbide bur and free hand conventional procedure

Intervention: Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis (Procedure)

Targeted Endodontic Microsurgery using trephine drill and 3d printed surgical guide

Experimental

Endodontic Microsurgery using 3d printed static surgical guide using patient's cbct data

Intervention: Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data (Procedure)

Outcomes

Primary Outcomes

Quality of life following periapical surgery

Time Frame: 1 year

Quality of life quantified using Questionnaire to both groups

Secondary Outcomes

  • Radiographic healing(1 year)
  • Time Taken for surgery(one year)
  • Accuracy of surgical access(one year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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