Diagnoses DiseaseNCT04689126
Effect of Cone Beam Computed Tomography on Diagnostic and Therapeutic Decision Making
A study testing surgical or nonsurgical endodontic treatment in people with Diagnoses Disease, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
this study will determine the effect of CBCT examinations on diagnostic and therapeutic decision making in endodontics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- surgical or nonsurgical endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2016to 30 Apr 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria for referring patients to CBCT examination will be in accordance with current European guidelines and can be grouped as follows:
- Patients in which disease had to be ruled out:
- patients with symptomatic vital teeth otherwise judged healthy (no exposed dentin; normal sensitivity pulp tests; no tenderness to palpation or percussion; with radiographic apical/marginal periodontal normalcy; and no cracks/fractures)
- patients with symptomatic root-filled teeth otherwise judged healthy (good quality of root filling that did not need to be revised or completed; no tenderness to palpation or percussion; with radiographic apical/marginal periodontal normalcy; and no cracks/fractures)
- when conventional radiology failed to demonstrate if a finding was a pathological process or a normal anatomical structure.
- Patients in which suspected disease had to be confirmed:
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- suspected dental fractures that could not be demonstrated
- suspected external or internal resorptions.
- As an aid in performing the therapeutic intervention:
- in established external or internal resorptions to assist in the approach of complex cases
- before apical surgery when important anatomical structures interfered with the surgical approach
- in diagnosing foreign body structures, their location and, when needed, as a guide in the surgical removal
- in understanding tooth anatomy of abnormal teeth in need of endodontic treatment
- in assessing the number and location of root canals after at least one unsuccessful attempt to find them under oral microscope.
Who cannot join
- Patients will not be referred for CBCT examination if they:
- presented themselves with an accessible previous volume tomography in the region of interest. This was, however, not a strict restriction if the examiner judged that new and relevant information could be obtained by a new CBCT examination
- had a definite diagnosis and treatment plan after a complete clinical and conventional radiographic examination and therefore did not need a CBCT examination. This group represented the vast majority of all patients
- needed any other special imaging technique for soft tissue assessment such as CT or magnetic resonanace imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cone Beam Computed Tomography on Diagnostic and Therapeutic Decision Making in Endodontics
this study will determine the effect of CBCT examinations on diagnostic and therapeutic decision making in endodontics.
Read the detailed description
Patients selected for Cone beam computed tomography (CBCT) examinations in accordance with European Commission guidelines ( patients with symptomatic vital teeth or with symptomatic root filled teeth; patients with suspected dental fracture; patients with suspected external or internal resorption and for aid in performing any therapeutic intervention ) will be included in the study. Only patients aged above 18 years will be included in the study.
Patients referred to the department of endodontics at Post Graduate Institute of Dental Sciences (PGIDS) Rohtak or any patient from routine opd requiring specialist endodontic consultation will be thoroughly examined .The examination will consist of a proper medical history and clinical examination, such as inspection, palpation, probing and percussion of the area of interest. When appropriate, additional tests such as sensitivity tests (cold and electric pulp tests) and conventional radiography will be performed. After the initial examination, patients judged to be in need of CBCT examination will be referred to the radiology department.
Stages of evaluation
Stage 1(before CBCT examination) Before referral, the examiner will write down the best available diagnosis and therapeutic plan using clinical examination and conventional radiography. The radiographs will be carefully viewed for periapical changes, vertical root fractures, internal or external resorption, perforation or any other radiographic finding.
Stage 2(after CBCT examination)
After the CBCT examination, the previous diagnosis and treatment plan will be considered and, if needed, a new diagnosis and treatment plan will be made by the same examiner, taking into consideration all of the data. The examiners will have access to all image reconstructions performed by the radiologist. These reconstructions will include images in the axial, coronal and sagittal planes throughout the entire volume.
Stage 3(patient dismissal) As per requirement therapy will be performed on the patients. The findings of orthograde treatment, explorative surgery, endodontic microsurgery, or extraction will serve as a gold standard for definitive clinical diagnosis.
Radiological investigation All intraoral periapical radiographs will be done with at least two angled (mesial and distal) views.
CBCT examination (Kodak CS 9300 Care Stream) done with exposure parameters 85 kilovolt and 5ma isotropic voxels with a size of 90*90*90 microns 5 *5 cm volume FOV Slice thickness will vary from .9 to 1.3 mm.
The images will be viewed on a screen with a resolution of 1280*1024pixels (Dell E19135).
Diagnostic decision making The diagnosis with periapical radiograph and CBCT will be made as per following choices
- Healthy
- Pulp necrosis
- Apical periodontitis
- External resorption
- Root fracture
- Non-endodontic diagnosis
- Others
Therapeutic decision making
Treatment plans decided by radiographs and CBCT will be divided into following choices
- No treatment
- Wait and watch
- Orthograde endodontics
- Retrograde endodontics
- Explorative surgery
- Extraction
- Referral to other specialist
- Others
- Conditions
- Diagnoses Disease
- Being tested
- surgical or nonsurgical endodontic treatment
- Keywords
- resorption, fracture, pulp necrosis, nonendodontic diagnosis
- Medical subject headings
- Fractures, Bone, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical or nonsurgical endodontic treatmentProcedure or surgery
Also called extraction, root amputation
Change in diagnosis and treatment plans between the two imaging - periapical radiography and cone beam computed tomography
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | diagnosis and treatment plan before and after cone beam computed tomography scan Receives: Procedure: surgical or nonsurgical endodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diagnosis and treatment planning
Comparison of diagnostic and therapeutic decision making between gold standard and radiographic findings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Nov 2016
- Primary completion30 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689126
- Sponsor's protocol ID
- natwar singh
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cone Beam Computed Tomography on Diagnostic and Therapeutic Decision Making in Endodontics
- ClinicalTrials.gov ID
- NCT04689126
- Acronym / sponsor ID
- natwar singh
- Conditions
- Diagnoses Disease
- Keywords
- resorption, fracture, pulp necrosis, nonendodontic diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 30 Dec 2020 (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.
this study will determine the effect of CBCT examinations on diagnostic and therapeutic decision making in endodontics.
Detailed description
Patients selected for Cone beam computed tomography (CBCT) examinations in accordance with European Commission guidelines ( patients with symptomatic vital teeth or with symptomatic root filled teeth; patients with suspected dental fracture; patients with suspected external or internal resorption and for aid in performing any therapeutic intervention ) will be included in the study. Only patients aged above 18 years will be included in the study.
Patients referred to the department of endodontics at Post Graduate Institute of Dental Sciences (PGIDS) Rohtak or any patient from routine opd requiring specialist endodontic consultation will be thoroughly examined .The examination will consist of a proper medical history and clinical examination, such as inspection, palpation, probing and percussion of the area of interest. When appropriate, additional tests such as sensitivity tests (cold and electric pulp tests) and conventional radiography will be performed. After the initial examination, patients judged to be in need of CBCT examination will be referred to the radiology department.
Stages of evaluation
Stage 1(before CBCT examination) Before referral, the examiner will write down the best available diagnosis and therapeutic plan using clinical examination and conventional radiography. The radiographs will be carefully viewed for periapical changes, vertical root fractures, internal or external resorption, perforation or any other radiographic finding.
Stage 2(after CBCT examination)
After the CBCT examination, the previous diagnosis and treatment plan will be considered and, if needed, a new diagnosis and treatment plan will be made by the same examiner, taking into consideration all of the data. The examiners will have access to all image reconstructions performed by the radiologist. These reconstructions will include images in the axial, coronal and sagittal planes throughout the entire volume.
Stage 3(patient dismissal) As per requirement therapy will be performed on the patients. The findings of orthograde treatment, explorative surgery, endodontic microsurgery, or extraction will serve as a gold standard for definitive clinical diagnosis.
Radiological investigation All intraoral periapical radiographs will be done with at least two angled (mesial and distal) views.
CBCT examination (Kodak CS 9300 Care Stream) done with exposure parameters 85 kilovolt and 5ma isotropic voxels with a size of 90*90*90 microns 5 *5 cm volume FOV Slice thickness will vary from .9 to 1.3 mm.
The images will be viewed on a screen with a resolution of 1280*1024pixels (Dell E19135).
Diagnostic decision making The diagnosis with periapical radiograph and CBCT will be made as per following choices
- Healthy
- Pulp necrosis
- Apical periodontitis
- External resorption
- Root fracture
- Non-endodontic diagnosis
- Others
Therapeutic decision making
Treatment plans decided by radiographs and CBCT will be divided into following choices
- No treatment
- Wait and watch
- Orthograde endodontics
- Retrograde endodontics
- Explorative surgery
- Extraction
- Referral to other specialist
- Others
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: surgical or nonsurgical endodontic treatmentdiagnosis and treatment plan before and after cone beam computed tomography scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The inclusion criteria for referring patients to CBCT examination will be in accordance with current European guidelines and can be grouped as follows:
Key exclusion criteria (4 listed)
- Patients will not be referred for CBCT examination if they:
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 |
|---|---|---|
| surgical or nonsurgical endodontic treatmentAlso: extraction, root amputationChange in diagnosis and treatment plans between the two imaging - periapical radiography and cone beam computed tomography | Procedure or surgery | intervention |
Primary outcome
Change in diagnosis and treatment planning
Time frame: 1 year
Comparison of diagnostic and therapeutic decision making between gold standard and radiographic findings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical or nonsurgical endodontic treatment in people with Diagnoses Disease, run by Postgraduate Institute of Dental Sciences Rohtak 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 30 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diagnosis and treatment planning (time frame: 1 year). 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 30 Dec 2020.