Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial

Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"

Study Overview

• Status: Recruiting
• Conditions: Periapical Lesion
• Intervention / Treatment: Procedure: Surgery under loupes; Procedure: surgery performed under microscope

Detailed Description

: Residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. The prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. Endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. Magnification has been recommended for better visualization of apical terminus. Various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). However, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices.

To the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DR. Sanjay Tewari, MDS, MDS; Phone Number: 09416259534; Email: tewarisanjayrohtak@yahoo.com
• Study Contact Backup: Name: Jyoti Nadekar, PG student; Phone Number: 8689830886; Email: jyotinadekar25@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: Jyoti Nadekar, PG student; Phone Number: 8689830886; Email: jyotinadekar25@gmail.com
      • Contact: DR. Sanjay Tewari, MDS; Phone Number: 09416259534; Email: principalpgids@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (Bharathi et al 2021) Tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. ASA-1 patients according to the classification of the American Society of Anesthesiologists).

Exclusion Criteria:

Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) Combined endodontic-periodontic lesions Pregnancy

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Loupes group; Surgery performed under loupes	Procedure: Surgery under loupes; surgery performed under loupes; Procedure: surgery performed under microscope; surgery performed under microscope
Experimental: Microscope group; Surgery performed under microscope	Procedure: Surgery under loupes; surgery performed under loupes; Procedure: surgery performed under microscope; surgery performed under microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	To determine the quality of life after endodontic microsurgery with high and low magnification using modified version of sugars et al and OHIP by tsesis et al. assessed by 5-point Likert scale till 1 week.	till 7 days after surgery
Healing assessment	2D radiographic healing was assessed by the criteria followed by RUD et al and MOLVEN et al , 3D CBCT healing was assessed by modified PENN'S criteria	After 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Pain assessment by VAS (0 - 100), where 0 is no pain and 100 is worst possible pain.	till 7 postoperative days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Jyoti Dnyaneshwar Nadekar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No