Decayed TeethNCT04817852
Morphological Root Canal Variation in C-shaped Canal Will be Assessed for Age by Using Cone Beam Computed Tomography
A study testing CBCT data of c-shaped canal in mandibular second molar. in people with Decayed Teeth, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
Trial summary
CBCT Data Of C-Shaped Canal In Mandibular Second Molar Will Be Assessed For Age. Read more about this study
- Who is it for?
- Ages 13 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Teeth
- What is being tested?
- CBCT data of c-shaped canal in mandibular second molar.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- In lower second molar with C-shaped canal.
Who cannot join
- Patient not willing for CBCT.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
CSI College of Dental Sciences And Research
Madurai, Tamil Nadu, 625001
Jasmin Shamili, MDS 1 YEAR, 9445983702, jasminshamili08@gmail.com
About this study
Official title: Influence Of Age And Radiograph Presentation on C-Shaped Canal Morphology In Mandibular Second Molar By Using CBCT Analysis
CBCT Data Of C-Shaped Canal In Mandibular Second Molar Will Be Assessed For Age.
Read the 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.
- Conditions
- Decayed Teeth
- Being tested
- CBCT data of c-shaped canal in mandibular second molar.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT data of c-shaped canal in mandibular second molar.Other
Detection of variation in root canal morphology in mandibular second molar by using CBCT.
| Study group | Role | What they receive |
|---|---|---|
| CBCT data of C-shaped canal in mandibular second molar will Be assessed for age. | Experimental | Detection of variation in root canal morphology by using CBCT. Receives: Other: CBCT data of c-shaped canal in mandibular second molar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Evaluation of CBCT data up to 2 years.
Secondary outcomes (1)
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.
Measured: Evaluation of CBCT data up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSI College of Dental Sciences and Research, Madurai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, V JASMIN SHAMILI, CSI College of Dental Sciences and Research, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817852
- Sponsor's protocol ID
- CSI
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Age And Radiograph Presentation on C-Shaped Canal Morphology In Mandibular Second Molar By Using CBCT Analysis
- ClinicalTrials.gov ID
- NCT04817852
- Acronym / sponsor ID
- CSI
- Conditions
- Decayed Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CSI College of Dental Sciences and Research, MaduraiUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT data of C-shaped canal in mandibular second molar will Be assessed for age. | Experimental | Other: CBCT data of c-shaped canal in mandibular second molar.Detection of variation in root canal morphology by using CBCT. |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- In lower second molar with C-shaped canal.
Key exclusion criteria (1 listed)
- Patient not willing for CBCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCT data of c-shaped canal in mandibular second molar.Detection of variation in root canal morphology in mandibular second molar by using CBCT. | Other | CBCT data of C-shaped canal in mandibular second molar will Be assessed for age. |
Primary outcome
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
Time frame: Evaluation of CBCT data up to 2 years.
To classify the C-shaped canal according to morphology in mandibular second molar by using cone beam computed tomography
1 secondary outcome
Morphological root canal variation in c shaped canal in mandibular second molar will be assessed for 180 participants by using cone beam computed tomography.
Time frame: Evaluation of CBCT data up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT data of c-shaped canal in mandibular second molar. in people with Decayed Teeth, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Evaluation of CBCT data up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.