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

NCT ID: NCT06642415

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-05-01

Brief Summary

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

Detailed Description

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: 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.

Conditions

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Periapical Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Sham piezoelectric setup for patients undergoing conventional surgery.

Study Groups

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Loupes group

Surgery performed under loupes

Group Type ACTIVE_COMPARATOR

Surgery under loupes

Intervention Type PROCEDURE

surgery performed under loupes

surgery performed under microscope

Intervention Type PROCEDURE

surgery performed under microscope

Microscope group

Surgery performed under microscope

Group Type EXPERIMENTAL

Surgery under loupes

Intervention Type PROCEDURE

surgery performed under loupes

surgery performed under microscope

Intervention Type PROCEDURE

surgery performed under microscope

Interventions

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Surgery under loupes

surgery performed under loupes

Intervention Type PROCEDURE

surgery performed under microscope

surgery performed under microscope

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PGIDS

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR. Sanjay Tewari, MDS, MDS

Role: CONTACT

09416259534

Jyoti Nadekar, PG student

Role: CONTACT

8689830886

Facility Contacts

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DR. Sanjay Tewari, MDS

Role: primary

09416259534

Jyoti Nadekar, PG student

Role: backup

8689830886

Other Identifiers

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Jyoti Dnyaneshwar Nadekar

Identifier Type: -

Identifier Source: org_study_id

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