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

NCT06642415 | Recruiting

• 1 other identifier: Jyoti Dnyaneshwar Nadekar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periapical Lesion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain assessment

  till 7 postoperative days

Study Arms (2)

Loupes group

ACTIVE COMPARATOR

Surgery performed under loupes

Procedure: Surgery under loupes; Procedure: surgery performed under microscope

Microscope group

EXPERIMENTAL

Surgery performed under microscope

Procedure: Surgery under loupes; Procedure: surgery performed under microscope

Interventions

Surgery under loupes PROCEDURE

surgery performed under loupes

Loupes group; Microscope group

surgery performed under microscope PROCEDURE

surgery performed under microscope

Loupes group; Microscope group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Central Study Contacts

DR. Sanjay Tewari, MDS, MDS

CONTACT

09416259534; tewarisanjayrohtak@yahoo.com

Jyoti Nadekar, PG student

CONTACT

8689830886; jyotinadekar25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham piezoelectric setup for patients undergoing conventional surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IN (1)