Periodontal Bone Defects Will be Detected and Measured by 2 Techniques CBCT and Intraoral Digital Radiography to Compare the Accuracy of These TechniquesNCT03729843
Cone Beam Computed Tomography Versus Intraoral Digital Radiography in Detection and Measurements of Simulated Periodontal Bone Defects
An observational study of Periodontal Bone Defects Will be Detected and Measured by 2 Techniques CBCT and Intraoral Digital Radiography to Compare the Accuracy of These Techniques, run by Marwa Mohamed Ali.
Trial summary
The selection of a regenerative approach is primarily based on the configuration of the intrabony defect and esthetic risk of treatment. Accurate diagnosis of periodontal bone defects, such as vertical bone defects or furcation involvements, is a challenge for dental clinicians. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontal Bone Defects Will be Detected and Measured by 2 Techniques CBCT and Intraoral Digital Radiography to Compare the Accuracy of These Techniques
- What is being tested?
- CBCT and intraoral digital radiography
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2018to 10 Nov 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patially or fully dentate dry jaws that match with the inclusion and exclusion criteria.
Who may be able to join
- • The selected dry jaws should be intact with no mechanical damage (chips, cracks, or fractures in the alveolar process).
- The teeth will be naturally attached to human jaws.
- The study samples will not identified by age or gender group.
Who cannot join
- • teeth with metallic restorations to avoid artifacts generation on CBCT scanning.
- Teeth with anomalies and fractures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cone Beam Computed Tomography Versus Intraoral Digital Radiography in Detection and Measurements of Simulated Periodontal Bone Defects Diagnostic Accuracy Study
The selection of a regenerative approach is primarily based on the configuration of the intrabony defect and esthetic risk of treatment. Accurate diagnosis of periodontal bone defects, such as vertical bone defects or furcation involvements, is a challenge for dental clinicians. A deficiency in comprehensive diagnosis may result in: 1) compromised prognosis of teeth; 2) changes in treatment plan; 3) unnecessary treatment; 4) longer treatment time; and 5) unanticipated treatment costs.
Thus, it is very important to have access to accurate diagnostic tools that can aid clinicians in cultivating an appropriate treatment choice. Periodontal assessments utilizing both clinical and radiographic examinations allow for the establishment of an accurate diagnosis as well as subsequent treatment choices.
Read more
Radiography plays an important role in periodontal diagnosis mainly because radiographs can reveal the amount and type of damage caused to the alveolar bone.
Digital imaging technique has created challenging opportunities for dental radiographic diagnosis. Digora was the first digital system for dental radiography based on a photostimulable phosphor technology.
E9ickholz et al. at 1999 compared linear measurements of interproximal bone loss on digitized radiographic images after application of different filters to the gold standard of intrasurgical measurements they concluded that all radiographic assessments on the digitized images came close to the intasurgical gold standard.
2D technologies do not allow for measurement of the bucco-lingual (B-L) width of the defect. Only the vertical height and the mesio-distal (M-D) width of the defect can be measured with 2D images.
Use of 3D volumetric images and 2D images in artificial bone defects have shown that CBCT has a sensitivity of 80% to 100% in detection and classification of bone defects, while intraoral radiographs present a sensitivity of 63% to 67%.
When compared with periapical and panoramic images, the CBCT has also shown an absence of distortion and overlapping, and the dimensions of the images that it presents were compatible with the actual size of the individual.
A few studies have been published comparing CBCT with digital radiography for the detection and measurements of periodontal bone defects.
Read the detailed description
Periodontal disease is caused by an imbalance between bone formation and resorption, leading to an ultimate reduction in bone height. Detection of periodontal disease is important in the prevention of tooth loss. The detection and accurate assessment of the location, extent and configuration of the endosseous defect is important for the determination of the tooth prognosis, the treatment plan and the maintenance procedures.
Regenerative therapies for both intrabony and furcation defects are viable options, but early management of these defects offers the greatest potential for periodontal health. Intrabony defect morphology as well as degree of furcation involvement may affect overall regenerative outcomes and/or optimal treatment strategies.
Radiographic bone loss is also useful for assigning descriptors to indicate severity of periodontitis: <1/3 bone loss = mild, 1/3 to ½ bone loss = moderate, and >½ bone loss = severe. Classification of bony defects given by Papapanou et al. 2000 was used to differentiate bone defects into: Suprabony defects (SB), Infrabony defects (IB), Interradicular defects (IR).For classifying the intrabony defects (IT), the investigators used classification system by Goldman and Cohen 1958 which classified the IT defects into: 1 wall, 2 wall , 3 wall and Combined bone defects (CB). Other bone defects (OB) were classified by their topography as:Bulbous bone contour (BB), Reversed architecture (RA), Dehiscence (DH).
The potentially existing radiological furcation involvement was examined by identifying the furcation upper boundary and furcation lower boundary and was classified as Subclass A, B, and C according to the classification system by Tarnow and Fletcher 1984, where he added the vertical component to the diagnosis of furcation involvement. Subclass based on the vertical bone resorption from the furcation fornix was added.
- Subclass A: Denotes furcation involvements with vertical bone loss of 3 mm or less.
- Subclass B: Denotes furcation involvements with vertical bone loss from 4 to 6 mm.
- Subclass C: Presents with bone loss from the fornix of 7 mm or more.
- The SB, IB, and OB defects were considered as absolute defects while IR defects were considered as relative defects because IR defects do not depict a particular bone lesion or defect rather they represent the stage in progress of periodontitis, i.e., once the periodontal disease progresses or its severity increases, it is bound to erode the bone between the multirooted teeth and involve the furcation.
Digital radiography is changing the diagnosis and treatment of dental diseases by incorporating computer technology into the field of dentistry. digital radiography have several advantages over film radiography, including immediate image production with solid-state devices; interactive display on a monitor with the ability to enhance image features and make direct linear and densitometric measurements; integrated storage; fast communication of images; lower contamination of the environment; security mechanisms to identify original images; ability to tag information such as a patient identifier, date of exposure and other relevant details; interoperability of the Digital Imaging and Communications in Medicine (DICOM) file format, which enables practitioners with different equipment and software to view and enhance the same images.
Furthermore, digital radiography offers a plethora of technical innovations to dentistry and is sure to significantly influence the arts of diagnosis, monitoring, research, as well as the treatment of dental diseases.
Cone beam computed tomography (CBCT) is a relatively new extra-oral imaging system which was specifically developed to overcome the limitations of periapical radiographs as it produces undistorted 3D information of the maxillofacial skeleton with a substantially lower radiation dose compared to conventional CT.
Consequently, CBCT has the potential to become non-invasive diagnostic instrument for various dental applications in which defect characterization, localization and volume measurements are important.
CBCT is currently being considered as a superior diagnostic tool for applications in periodontology. CBCT scanning was found to be more effective than other 2D imaging modalities in assessing periodontal structures. As CBCT had better potential of detecting periodontal bone defects in all directions compared with periapical radiographs. More over interproximal areas also, buccal and lingual defects could not be recognized from each other with intraoral radiographs.
- Being tested
- CBCT and intraoral digital radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT and intraoral digital radiographyRadiation
Simulated periodontal bone defects will be measured by 2 techniques: group I detected and measured using CBCT and group II intraoral digital radiography and all the measurements will be compared with the gold standard real measurements on the dry jaws
| Study group | Role | What they receive |
|---|---|---|
| CBCT and intraoral digital radiography | simulated bone defects will be detected and measured by 2 techniques using CBCT and using intraoral digital radiography and the all measurements will be compared with the gold standard real measurements on the dry jaws Receives: Radiation: CBCT and intraoral digital radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCT and Intraoral Digital Radiography
Detection and measuring of artificially prepared periodontal bone defects.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start10 Nov 2018 (estimated)
- Primary completion10 Nov 2019 (estimated)
- Study completion10 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Bone Defects Will be Detected and Measured by 2 Techniques CBCT and Intraoral Digital Radiography to Compare the Accuracy of These TechniquesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Mohamed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Mohamed Ali, Cairo University
- Investigators
- Hossam Kandil, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729843
- Sponsor's protocol ID
- HPHH
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cone Beam Computed Tomography Versus Intraoral Digital Radiography in Detection and Measurements of Simulated Periodontal Bone Defects Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03729843
- Acronym / sponsor ID
- HPHH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Marwa Mohamed AliUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 10 Nov 2019 (estimated)
- Study completion
- 10 Nov 2020 (estimated)
- First posted
- 5 Nov 2018 (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.
The selection of a regenerative approach is primarily based on the configuration of the intrabony defect and esthetic risk of treatment. Accurate diagnosis of periodontal bone defects, such as vertical bone defects or furcation involvements, is a challenge for dental clinicians. A deficiency in comprehensive diagnosis may result in: 1) compromised prognosis of teeth; 2) changes in treatment plan; 3) unnecessary treatment; 4) longer treatment time; and 5) unanticipated treatment costs.
Thus, it is very important to have access to accurate diagnostic tools that can aid clinicians in cultivating an appropriate treatment choice. Periodontal assessments utilizing both clinical and radiographic examinations allow for the establishment of an accurate diagnosis as well as subsequent treatment choices.
Radiography plays an important role in periodontal diagnosis mainly because radiographs can reveal the amount and type of damage caused to the alveolar bone.
Digital imaging technique has created challenging opportunities for dental radiographic diagnosis. Digora was the first digital system for dental radiography based on a photostimulable phosphor technology.
E9ickholz et al. at 1999 compared linear measurements of interproximal bone loss on digitized radiographic images after application of different filters to the gold standard of intrasurgical measurements they concluded that all radiographic assessments on the digitized images came close to the intasurgical gold standard.
2D technologies do not allow for measurement of the bucco-lingual (B-L) width of the defect. Only the vertical height and the mesio-distal (M-D) width of the defect can be measured with 2D images.
Use of 3D volumetric images and 2D images in artificial bone defects have shown that CBCT has a sensitivity of 80% to 100% in detection and classification of bone defects, while intraoral radiographs present a sensitivity of 63% to 67%.
When compared with periapical and panoramic images, the CBCT has also shown an absence of distortion and overlapping, and the dimensions of the images that it presents were compatible with the actual size of the individual.
A few studies have been published comparing CBCT with digital radiography for the detection and measurements of periodontal bone defects.
Detailed description
Periodontal disease is caused by an imbalance between bone formation and resorption, leading to an ultimate reduction in bone height. Detection of periodontal disease is important in the prevention of tooth loss. The detection and accurate assessment of the location, extent and configuration of the endosseous defect is important for the determination of the tooth prognosis, the treatment plan and the maintenance procedures.
Regenerative therapies for both intrabony and furcation defects are viable options, but early management of these defects offers the greatest potential for periodontal health. Intrabony defect morphology as well as degree of furcation involvement may affect overall regenerative outcomes and/or optimal treatment strategies.
Radiographic bone loss is also useful for assigning descriptors to indicate severity of periodontitis: <1/3 bone loss = mild, 1/3 to ½ bone loss = moderate, and >½ bone loss = severe. Classification of bony defects given by Papapanou et al. 2000 was used to differentiate bone defects into: Suprabony defects (SB), Infrabony defects (IB), Interradicular defects (IR).For classifying the intrabony defects (IT), the investigators used classification system by Goldman and Cohen 1958 which classified the IT defects into: 1 wall, 2 wall , 3 wall and Combined bone defects (CB). Other bone defects (OB) were classified by their topography as:Bulbous bone contour (BB), Reversed architecture (RA), Dehiscence (DH).
The potentially existing radiological furcation involvement was examined by identifying the furcation upper boundary and furcation lower boundary and was classified as Subclass A, B, and C according to the classification system by Tarnow and Fletcher 1984, where he added the vertical component to the diagnosis of furcation involvement. Subclass based on the vertical bone resorption from the furcation fornix was added.
- Subclass A: Denotes furcation involvements with vertical bone loss of 3 mm or less.
- Subclass B: Denotes furcation involvements with vertical bone loss from 4 to 6 mm.
- Subclass C: Presents with bone loss from the fornix of 7 mm or more.
- The SB, IB, and OB defects were considered as absolute defects while IR defects were considered as relative defects because IR defects do not depict a particular bone lesion or defect rather they represent the stage in progress of periodontitis, i.e., once the periodontal disease progresses or its severity increases, it is bound to erode the bone between the multirooted teeth and involve the furcation.
Digital radiography is changing the diagnosis and treatment of dental diseases by incorporating computer technology into the field of dentistry. digital radiography have several advantages over film radiography, including immediate image production with solid-state devices; interactive display on a monitor with the ability to enhance image features and make direct linear and densitometric measurements; integrated storage; fast communication of images; lower contamination of the environment; security mechanisms to identify original images; ability to tag information such as a patient identifier, date of exposure and other relevant details; interoperability of the Digital Imaging and Communications in Medicine (DICOM) file format, which enables practitioners with different equipment and software to view and enhance the same images.
Furthermore, digital radiography offers a plethora of technical innovations to dentistry and is sure to significantly influence the arts of diagnosis, monitoring, research, as well as the treatment of dental diseases.
Cone beam computed tomography (CBCT) is a relatively new extra-oral imaging system which was specifically developed to overcome the limitations of periapical radiographs as it produces undistorted 3D information of the maxillofacial skeleton with a substantially lower radiation dose compared to conventional CT.
Consequently, CBCT has the potential to become non-invasive diagnostic instrument for various dental applications in which defect characterization, localization and volume measurements are important.
CBCT is currently being considered as a superior diagnostic tool for applications in periodontology. CBCT scanning was found to be more effective than other 2D imaging modalities in assessing periodontal structures. As CBCT had better potential of detecting periodontal bone defects in all directions compared with periapical radiographs. More over interproximal areas also, buccal and lingual defects could not be recognized from each other with intraoral radiographs.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT and intraoral digital radiography | – | Radiation: CBCT and intraoral digital radiographysimulated bone defects will be detected and measured by 2 techniques using CBCT and using intraoral digital radiography and the all measurements will be compared with the gold standard real measurements on the dry jaws |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patially or fully dentate dry jaws that match with the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- • The selected dry jaws should be intact with no mechanical damage (chips, cracks, or fractures in the alveolar process).
Key exclusion criteria (2 listed)
- • teeth with metallic restorations to avoid artifacts generation on CBCT scanning.
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 and intraoral digital radiographySimulated periodontal bone defects will be measured by 2 techniques: group I detected and measured using CBCT and group II intraoral digital radiography and all the measurements will be compared with the gold standard real measurements on the dry jaws | Radiation | CBCT and intraoral digital radiography |
Primary outcome
CBCT and Intraoral Digital Radiography
Time frame: 24 months
Detection and measuring of artificially prepared periodontal bone defects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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.
Hossam Kandil, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Bone Defects Will be Detected and Measured by 2 Techniques CBCT and Intraoral Digital Radiography to Compare the Accuracy of These Techniques, run by Marwa Mohamed Ali.
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 3 inclusion and 2 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact marwa m ali, master (00201091608076, dentist-86-2009@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBCT and Intraoral Digital Radiography (time frame: 24 months). 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 6 Nov 2018.