Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment

NCT04333940 | Completed DMC

• 1 other identifier: Dr. G.Keerthana
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery.

Conditions

Periapical Diseases

Outcome Measures

Primary Outcomes (1)

• Postoperative healing

  Radiographic healing will be assessed in periapical radiography and CBCT after 12 months

  12 months

Secondary Outcomes (1)

• Quality of life assessment

  till 1 wek after surgery

Study Arms (2)

1. 3D CBCT GROUP

EXPERIMENTAL

Preoperative 3-dimensional CBCT will be taken.

Procedure: periapical surgery

2D PR GROUP

ACTIVE COMPARATOR

Preoperative 2-dimensional periapical radiographs will be taken using paralleling technique with customized Jig

Procedure: periapical surgery

Interventions

periapical surgery PROCEDURE

clinical signs and symptoms, probing depth, Clinical attachment level (CAL ), dimensions of lesion, distance from the defect and apex of tooth to the anatomical structures will be measured

1. 3D CBCT GROUP; 2D PR GROUP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient willingness to participate in the study.
• Patient's age more than 18 years.
• Failed root canal treated permanent teeth with post-treatment apical periodontitis requiring treatment.
• Patients referred for periapical surgery of permanent teeth because of separated instrument fragment, overextended root canal filling material or any other idiopathic reasons.
• Radiographic evidence of periapical radiolucency in failed root canal treated teeth.
• American classification of anesthesiologists (ASA) Class I or ASA Class 2 according to ASA classification.

You may not qualify if:

• Positive history of antibiotic use within past three months of the treatment.
• Positive history of analgesic use within the past 7 days.
• Procedural errors in previous root canal treatment which are not manageable.
• Patients who are pregnant, diabetic, having human immunodeficiency virus infection or other immune compromising conditions, had serious medical illness or requiring antibiotic premedication.
• Patients with unrestorable lesions, fractures involving the root and periodontium, and/or periodontally compromised teeth.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

Related Publications (1)

• Gurusamy K, Duhan J, Tewari S, Sangwan P, Gupta A, Mittal S, Kumar V, Arora M. Patient-centric outcome assessment of endodontic microsurgery using periapical radiography versus cone beam computed tomography: A randomized clinical trial. Int Endod J. 2023 Jan;56(1):3-16. doi: 10.1111/iej.13837. Epub 2022 Oct 2.

  PMID: 36135595 DERIVED

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: January 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

IN (1)