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

Primary Purpose

Periapical Diseases

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
periapical surgery
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Post Graduate Institute of Dental Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1. 3D CBCT GROUP

2D PR GROUP

Arm Description

Preoperative 3-dimensional CBCT will be taken.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life assessment
likert scale of 1 to 5 1- not at all 5 - very much

Full Information

First Posted
April 1, 2020
Last Updated
December 10, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04333940
Brief Title
Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
Official Title
Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics. Study Design: - Prospective clinical trial Time Frame: - Jan 2019 to April 2020 Population / Participants: -Patients of age 18 years and above will be enrolled in the study. Sample size: - The anticipated change in treatment plan was expected to be 53% before and after using CBCT. Based on the available data , sample size was calculated to enroll a minimum of 18 patients in each group with a power level of 90% and alpha at the 5% level. Considering the dropouts, a total of 50 patients (n=25 each group) will be recruited for the study. Method: - Study subjects will be recruited from the pool of patients enrolling in the Outpatient department meeting the inclusion criteria in the Post Graduate Department of Conservative Dentistry & Endodontics at PGIDS, Rohtak ,Haryana. Study will be performed after obtaining due ethical clearance from Institutional Ethical Committee of PGIDS. Patients are randomly divided into 2Dimensional periapical radiography (PA) group and 3Dimensional Cone beam computed tomography (CBCT) group. Preoperative radiographs (both PA radiography and CBCT) will be taken and periapical surgical procedures will be carried out under operating microscope by the standardized treatment methods. Surgical Technique: With the exception of incisions, flap elevation and suturing, all surgical procedures will be performed under operating microscope in an operating room under 8x to 16x magnification. The full thickness (mucoperiosteal flap) will be reflected under aseptic conditions - Preoperative mouth rinse with 0.2% chlorhexidine mouthwash will be used. Local anaesthesia with lidocaine 2% with epinephrine 1:1,00,000 will be achieved. Buccal intrasulcular incision will be given up to the alveolar crest including one tooth mesial to the lesion & one tooth distal to the lesion, using no.15 BP blade. Mesial and distal vertical releasing incision will be given. Full thickness flap will be gently reflected towards the apical area by periosteal elevator. The flap will be frequently irrigated with sterile saline to prevent dehydration of periosteal surface. After complete elevation of the flap, bone cutting is done using bur and complete debridement of the bony lesion will be performed by surgical curettes For additional hemostasis during surgery cotton pellets soaked in 0.1% epinephrine will be applied topically as required. A 2-3mm root tip with a 0º to 10º bevel angle will be resected with cylindrical surgical carbide bur at high speed with sterile water coolant. Root end preparations extending 3mm into the canal space along the long axis of the root will be made using piezoelectric ultrasonic retrotips in both groups. Isthmuses, fins, and other significant anatomic irregularities will be identified in high magnification and will be treated with the ultrasonic instruments. Root end filling will be done with mineral trioxide aggregrate (MTA). The adaptation of the filling material to the canal apical walls will be confirmed with the aid of an operating microscope at high magnification. Later wound site will be closed and sutured with 4-0 silk suture after irrigating the defect properly. Post - Operative Follow-Up: Clinical and 2D periapical radiographic examinations will be performed every 3, 6, 9 and 12 months by assessing the same parameters as baseline except that PD, CAL will not be measured until 12 months .CBCT scan will be done at 12 months follow up . Routine examination procedure will be used to evaluate any evidence of clinical signs and/or symptoms. Postoperative complications and Oral Health Related Quality of Life (OHQoL) questionnaire response will be assessed. Healing Outcome measurement: 2D Radiographic healing will be assessed by the criteria followed by Rud et al (1972) and Molven et al (1987) Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure) Patient assessment of quality of life following surgical endodontic treatment: Each patient received a questionnaire to fill out for each day starting the day of surgery for 7 days postoperatively. The questionnaire consisted of 15 questions in which patients were to evaluate their quality of life with the 5-point Likert- type scale, ranging from 1 (not at all) to 5 (very much). 3 Dimensionally at 12 months of follow up periapical healing will be assessed by modified PENN 3D criteria: Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. 3D CBCT GROUP
Arm Type
Experimental
Arm Description
Preoperative 3-dimensional CBCT will be taken.
Arm Title
2D PR GROUP
Arm Type
Active Comparator
Arm Description
Preoperative 2-dimensional periapical radiographs will be taken using paralleling technique with customized Jig
Intervention Type
Procedure
Intervention Name(s)
periapical surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative healing
Description
Radiographic healing will be assessed in periapical radiography and CBCT after 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life assessment
Description
likert scale of 1 to 5 1- not at all 5 - very much
Time Frame
till 1 wek after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Post Graduate Institute of Dental Science
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
36135595
Citation
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.
Results Reference
derived

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

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