Effect of Targeted Endodontic Microsurgery on Quality of Life and Healing on Mandibular Molars

NCT06643676 | Completed

• 1 other identifier: Muzaffar Khan
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Diseases; Periapical Periodontitis; Periapical Cyst; Periapical Granuloma; Periapical Pathology; Endodontic Microsurgery; Targeted Endodontic Microsurgery

Outcome Measures

Primary Outcomes (1)

• Quality of life following periapical surgery

  Quality of life quantified using Questionnaire to both groups

  1 year

Secondary Outcomes (3)

• Radiographic healing

  1 year

• Time Taken for surgery

  one year

• Accuracy of surgical access

  one year

Study Arms (2)

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

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

Conventional Endodontic microsurgery using burs

ACTIVE COMPARATOR

Conventional Endodontic microsurgery using carbide bur and free hand conventional procedure

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

Interventions

Targeted Endodontic Microsurgery Using 3d Printed surgical guide using the patient's CBCT data PROCEDURE

Patients with apical periodontitis with intact cortex in madibular molars receiving Targeted Endodontic surgery or Guided Endodontic Microsurgery with surgical guide fabricated using the cbct data following failure of non surgical root canal treatment

Also known as: periapical surgery, Targeted Endodontic Microsurgery, Guided Endodontic Microsurgery, apicoectomy

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

Conventional Endodontic Microsurgery with a free hand procedure using bur and CBCT analysis PROCEDURE

A conventional endodontic microsurgery using arbitrary localisation technique using the cbct data and performing the surgery with a carbide bur.

Conventional Endodontic microsurgery using burs

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in which non-surgical retreatment is unfeasible (post, anatomical complexity, iatrogenic errors) or previously failed treatment.
• Patients with persistent symptomatic apical periodontitis and periapical radiolucency.
• Tooth with a peri-radicular lesion of strictly endodontic origin (chronic apical periodontitis) and combined endodontic periodontic lesions with the size of lesion ≥5mm.
• Patients between 18-55 years of age.
• No general medical contraindications for oral surgical procedures (ASA-1 and ASA-2 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences , Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Diseases; Periapical Periodontitis; Radicular Cyst; Periapical Granuloma

Interventions

Apicoectomy

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Cyst; Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Endodontics; Dentistry

Study Officials

• Jigyasa grover, MDS

  PGIDS ROHTAK, HARYANA

  STUDY DIRECTOR

• sanjay Tewari, MDS

  PGIDS ROHTAK HARYANA

  STUDY CHAIR

• MOHAMMED MUZAFFAR KHAN, BDS

  PGIDS ROHTAK HARYANA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: October 16, 2024
• Study Start: July 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

IN (1)