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Recruiting NCT06642415

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

No phase Interventional Periapical Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery under loupes, surgery performed under microscope.
Who it may be relevant to
Registry conditions: Periapical Lesion. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Procedure Surgery under loupes
    surgery performed under loupes
  • Procedure surgery performed under microscope
    surgery performed under microscope

Primary outcome measures

  • Quality of life assessment [Time frame: till 7 days after surgery]
  • Healing assessment [Time frame: After 6 months and 12 months]
Secondary outcome measures (1)
  • Pain assessment [Time frame: till 7 postoperative days]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

India · 1 center
  • PGIDS — Rohtak

Identifiers

NCT: NCT06642415 · Jyoti Dnyaneshwar Nadekar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗