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Morphological Root Canal Variation in C-shaped Canal Will be Assessed for Age by Using Cone Beam Computed Tomography

Primary Purpose

Decayed Teeth

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
CBCT data of c-shaped canal in mandibular second molar.
Sponsored by
CSI College of Dental Sciences and Research, Madurai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decayed Teeth

Eligibility Criteria

13 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In lower second molar with C-shaped canal.

Exclusion Criteria:

  • Patient not willing for CBCT.

Sites / Locations

  • CSI College of Dental Sciences And ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBCT data of C-shaped canal in mandibular second molar will Be assessed for age.

Arm Description

Detection of variation in root canal morphology by using CBCT.

Outcomes

Primary Outcome Measures

Morphological variation in root canal anatomy of c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography
To classify the C-shaped canal according to morphology in mandibular second molar by using cone beam computed tomography

Secondary Outcome Measures

Morphological root canal variation in c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography.
By using artificial intelligence in detecting c-shaped canal morphology in mandibular second molar.

Full Information

First Posted
March 18, 2021
Last Updated
March 23, 2021
Sponsor
CSI College of Dental Sciences and Research, Madurai
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1. Study Identification

Unique Protocol Identification Number
NCT04817852
Brief Title
Morphological Root Canal Variation in C-shaped Canal Will be Assessed for Age by Using Cone Beam Computed Tomography
Official Title
Influence Of Age And Radiograph Presentation on C-Shaped Canal Morphology In Mandibular Second Molar By Using CBCT Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CSI College of Dental Sciences and Research, Madurai

4. Oversight

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

5. Study Description

Brief Summary
CBCT Data Of C-Shaped Canal In Mandibular Second Molar Will Be Assessed For Age.
Detailed Description
AIM: To determine the influence of age and radiograph presentation on C-shaped canal morphology in mandibular second molar by using CBCT Analysis. MATERIALS AND METHODS: After obtaining institutional ethics committee approval CSICDSR/IEC/0054/2018 a total of 112 cone beam computed tomography (CBCT) scans from mandibular second molar teeth with C-shaped canal was included for evaluation. These scans were obtained from patients referred to author's department for root canal treatment in the period from July 2016 to March 2020. Informed consent was obtained prior to CBCT scan recommendation. Mandibular molars in this study did not have any root fillings, had fully formed root apices and lack of root resorption. Mandibular second molars in this study were recommended for single tooth CBCT recordings when there was an indication of fused roots in the pre-operative periapical radiograph, with a confirmed C-shaped canal anatomy upon access and / or canal exploration; or with a master cone verification cone shift technique radiograph that a C-shaped canal was evident. Periapical radiographs were taken with paralleling cone technique using Blue dent X-ray machine (60-70 Kvp, 4-7 mA) and image acquisition was done with Vista Scan Mini plus . The CBCT machine Kodak CS 8100 3D was used for image acquisition with an exposure of 80 KV, 5mA , 19.96 secs and had a voxel size of 90 micro m. All images used 1mm slice thickness. Periapical radiograph image, axial, coronal and sagittal cross sections of root canal from CBCT were displayed in a monitor and inspected by two experienced endodontic post graduates. Cross sections of root canal were classified according to Fan et al. categorization. Intra- and Inter-observer calibrations had previously been done by assessing 20 selected CBCT volume recording of C-shaped mandibular second molar canal. Two observers analyzed the selected CBCT recordings twice with a 1 week interval between the assessments. Kappa test was done to evaluate the reliability of the observers. The kappa values ranged from 1.000 to 0.761 for inter-and intra-observation reflecting a high level of agreement. Cross section CBCT images were captured 1mm from root canal orifices, at the apical exit of canal and mid-way between the coronal and apical extent of the canal. Any controversies in assessment of images were discussed among the two observers; if consensus was not achieved an experienced endodontic teacher would assist in decision making along with re-examining and scrolling through of CBCT volume recording of the patient in all three planes using the software tools. The periapical radiographs were assessed by an experienced endodontist under 2.5X magnification and optimal light conditions. The C-shaped root appearance in the radiographs was categorized with a modified Gao et al. classification. The modification for the classification was, Type I - Merging: Canals merged into one major canal before exiting at the apical foramen. Type II - Symmetric: Separated mesial canal and distal canal located at the mesial part and distal part of the root, respectively. Maximum separation between the root canals should be > 1/3rd of distance between the mesial and distal maximum contour of the roots. From the buccal-lingual view, symmetry of the mesial canal and distal canal was present along the longitudinal axis of the root. Type III - Asymmetric: Separate mesial and distal canals were evident. From a buccal-lingual view, the distal canal may have a large isthmus across the furcation area, which commonly made the mesial and distal canal asymmetrical. Type IV - Merging symmetric: Canals merged into one major apical exit with partial dentin fusion area may appear in the coronal and (or) middle portion of the canal system. Maximum separation between the root canals should be > 1/3rd of distance between the mesial and distal maximum contour of the roots. Separated mesial and distal canals symmetry was present along the longitudinal axis of the root. Type V - Merging asymmetric: Canals merged into one major apical exit with partial dentin fusion area may appear in the coronal and (or) middle portion of the canal system. Separated mesial and distal canals asymmetry was present along the longitudinal axis of the root because of presence of large isthmus across the furcation area. Any variation that could not be accommodated within these established criteria were allocated as variable. C-shaped canal systems in mandibular second molars required three criteria (i) fused roots (ii) a longitudinal groove on the buccal or lingual surface, and (iii) at least one cross section of the canal belonging to classification C1, C2, C3 or C4. Differences in prevalence of different types of C-shaped root canal configurations between ages were compared using chi-squared test and ANOVA. Statistical analysis was performed using SPSS. P value < 0.05 was considered as significant difference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decayed Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBCT data of C-shaped canal in mandibular second molar will Be assessed for age.
Arm Type
Experimental
Arm Description
Detection of variation in root canal morphology by using CBCT.
Intervention Type
Other
Intervention Name(s)
CBCT data of c-shaped canal in mandibular second molar.
Intervention Description
Detection of variation in root canal morphology in mandibular second molar by using CBCT.
Primary Outcome Measure Information:
Title
Morphological variation in root canal anatomy of c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography
Description
To classify the C-shaped canal according to morphology in mandibular second molar by using cone beam computed tomography
Time Frame
Evaluation of CBCT data up to 2 years.
Secondary Outcome Measure Information:
Title
Morphological root canal variation in c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography.
Description
By using artificial intelligence in detecting c-shaped canal morphology in mandibular second molar.
Time Frame
Evaluation of CBCT data up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In lower second molar with C-shaped canal. Exclusion Criteria: Patient not willing for CBCT.
Facility Information:
Facility Name
CSI College of Dental Sciences And Research
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Shamili, MDS 1 YEAR
Phone
9445983702
Email
jasminshamili08@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Morphological Root Canal Variation in C-shaped Canal Will be Assessed for Age by Using Cone Beam Computed Tomography

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