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NCT Number: NCT06642415

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"

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Surgery under loupes

Procedure

surgery performed under loupes

surgery performed under microscope

Procedure

surgery performed under microscope

Primary outcomes

  1. Quality of life assessment

    Time frame: till 7 days after surgery

    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.

  2. Healing assessment

    Time frame: After 6 months and 12 months

    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

Secondary outcomes

  1. Pain assessment

    Time frame: till 7 postoperative days

    Pain assessment by VAS (0 - 100), where 0 is no pain and 100 is worst possible pain.

Study contacts

Contact information is provided by the study sponsor or research team.

DR. Sanjay Tewari, MDS, MDS

CONTACT

[email protected]

09416259534

Jyoti Nadekar, PG student

CONTACT

[email protected]

8689830886

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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