Back to resultsA Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images
Primary Purpose
Periodontal Diseases, Dental Caries
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bitewing X ray
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontal Diseases focused on measuring Radiography, Bitewing
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age.
- Patients who are currently be treated KAU dental clinics and meet all medical and dental requirements of the KAU clinic for treatments (e.g., subjects with no diseases contraindicating their dental treatment at KAU).
- Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding that required urgent treatment
- Non-smoker.
- Patients who have opposing teeth and no missing posterior or canine teeth in all quadrants (except third molars).
Exclusion Criteria:
- Have any known disease and would not allow the patient to be treatment planned for any procedures in the KAU clinics (e.g., severe anemia, low white blood cell count (Absolute Neutrophil Count (ANC) less than 1500, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates, endocrine-induced bone diseases (e.g. hyperparathyroidism), immunosuppressive therapy).
- Have limited mental capacity and unable to give informed consent.
- Be a pregnant or lactating female (self-reported)
- Have untreated malignant neoplasm.
- Individuals opposed to participate in the study.
- If a patient has a crown which will not be able to assess the caries boarder and cementoenamel junction.
if a patient has a gagging reflex or inability to open his/her mouth.
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vertical bitewing
horizontal bitewing
Arm Description
All of the bitewing radiographs will be evaluated by two experienced restorative dentists for caries. All observers will be instructed on the definition of the rating scale before the examination sessions. The observers will be using the following a 5-point confidence scale as follows: 1=caries definitely absent; 2=caries probably absent; 3=equal chance of caries being present or absent; 4=caries probably present; 5=caries definitely present. If caries was detected a second 5-point confidence scale as follows: 1=caries mostly absent (< 25%); 2=caries slightly presence( 25%-50%) ; 3=about half of the border are presence; 4=caries probably clear ( most boarders are presence); 5=caries definitely clear ( all borders are presence ).
All of the bitewing radiographs will be evaluated by two experienced periodontist for bone loss measurements. The steel wire will be used to determine the magnification factor as explained by G Li et al. 8 The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured mesially and distally twice and all these measurements will be adjusted using the steel measurement.9 All the measurements will be conducted using IC measure INK software.
Outcomes
Primary Outcome Measures
Caries detection
The observers will be using the following a 5-point confidence scale as follows: 1=caries definitely absent; 2=caries probably absent; 3=equal chance of caries being present or absent; 4=caries probably present; 5=caries definitely present. If caries was detected a second 5-point confidence scale as follows: 1=caries mostly absent (< 25%); 2=caries slightly presence( 25%-50%) ; 3=about half of the border are presence; 4=caries probably clear ( most boarders are presence); 5=caries definitely clear ( all borders are presence ).
Level of bone loss
All of the bitewing radiographs will be evaluated by two experienced periodontist for bone loss measurements. The steel wire will be used to determine the magnification factor as explained by G Li et al. 8 The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured mesially and distally twice and all these measurements will be adjusted using the steel measurement.9 All the measurements will be conducted using IC measure INK software.
Secondary Outcome Measures
Full Information
NCT ID
NCT04341636
First Posted
April 8, 2020
Last Updated
April 10, 2020
Sponsor
King Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT04341636
Brief Title
A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images
Official Title
A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images in Detecting Approximal Caries and Interdental Bone Loss in Posterior Teeth: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aims of this research are to determine if vertical bitewings will be more effective and more comprehensive for the diagnosis of caries and the level of alveolar bone loss than the horizontal bitewing technique for the patients at King Abdulaziz University over the age of 18. This is a cross sectional study. All the images in this study will be conducted at School of Dentistry, King Abdulaziz University. Each patients will be exposed to 4 horizontal bitewing for posterior teeth ( standard of care ) and 4 vertical bitewing for the same area ( experimental ). The radiographs will be processed digitally. All the x ray will be taken using the standard protection protocol.
Detailed Description
The aims of this research are to determine if vertical bitewings will be more effective and more comprehensive for the diagnosis of caries and the level of alveolar bone loss than the horizontal bitewing technique for the patients at King Abdulaziz University over the age of 18. This is a cross sectional study. All the images in this study will be conducted at School of Dentistry, King Abdulaziz University. Each patients will be exposed to 4 horizontal bitewing for posterior teeth ( standard of care ) and 4 vertical bitewing for the same area ( experimental ) . X ray will be taken using a film holder and a steel wire (3mm ) on the film holders. This steel wire will help to adjust for magnification later on. The x ray tube will be in the same distance (4mm from the x ray). The bitewing radiographs will be taken with double-packed Ekta speed Plus films on a radiograph machine operating at 70 kilovolt peak and 8 milliampere, having 2.5 aluminium filtration and a 0.860.8 mm focal spot, according to the manufacturer's exposure recommendations, with the parallel technique to obtain an accurate x ray as much as possible . The radiographs will be processed digitally. All the x ray will be taken using the standard protection protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Dental Caries
Keywords
Radiography, Bitewing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vertical bitewing
Arm Type
Experimental
Arm Description
All of the bitewing radiographs will be evaluated by two experienced restorative dentists for caries. All observers will be instructed on the definition of the rating scale before the examination sessions. The observers will be using the following a 5-point confidence scale as follows: 1=caries definitely absent; 2=caries probably absent; 3=equal chance of caries being present or absent; 4=caries probably present; 5=caries definitely present. If caries was detected a second 5-point confidence scale as follows: 1=caries mostly absent (< 25%); 2=caries slightly presence( 25%-50%) ; 3=about half of the border are presence; 4=caries probably clear ( most boarders are presence); 5=caries definitely clear ( all borders are presence ).
Arm Title
horizontal bitewing
Arm Type
Active Comparator
Arm Description
All of the bitewing radiographs will be evaluated by two experienced periodontist for bone loss measurements. The steel wire will be used to determine the magnification factor as explained by G Li et al. 8 The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured mesially and distally twice and all these measurements will be adjusted using the steel measurement.9 All the measurements will be conducted using IC measure INK software.
Intervention Type
Radiation
Intervention Name(s)
Bitewing X ray
Intervention Description
Each patients will be exposed to 4 horizontal bitewing for posterior teeth ( standard of care ) and 4 vertical bitewing for the same area ( experimental ) . X ray will be taken using a film holder and a steel wire (3mm ) on the film holders. This steel wire will help to adjust for magnification later on. The x ray tube will be in the same distance (4mm from the x ray).
The bitewing radiographs will be taken with double-packed Ekta speed Plus films on a radiograph machine operating at 0 kilovolt peak and 8 milliampere, having 2.5 aluminium filtration and a 0.860.8 mm focal spot, according to the manufacturer's exposure recommendations, with the parallel technique to obtain an accurate x ray as much as possible . The radiographs will be processed digitally. All the x ray will be taken using the standard protection protocol .
Primary Outcome Measure Information:
Title
Caries detection
Description
The observers will be using the following a 5-point confidence scale as follows: 1=caries definitely absent; 2=caries probably absent; 3=equal chance of caries being present or absent; 4=caries probably present; 5=caries definitely present. If caries was detected a second 5-point confidence scale as follows: 1=caries mostly absent (< 25%); 2=caries slightly presence( 25%-50%) ; 3=about half of the border are presence; 4=caries probably clear ( most boarders are presence); 5=caries definitely clear ( all borders are presence ).
Time Frame
1 month
Title
Level of bone loss
Description
All of the bitewing radiographs will be evaluated by two experienced periodontist for bone loss measurements. The steel wire will be used to determine the magnification factor as explained by G Li et al. 8 The steel wire and cemento enamel junction (CEJ) - if not obscure by caries - will be used as reference points for bone loss measurements. Each tooth will be measured mesially and distally twice and all these measurements will be adjusted using the steel measurement.9 All the measurements will be conducted using IC measure INK software.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age.
Patients who are currently be treated KAU dental clinics and meet all medical and dental requirements of the KAU clinic for treatments (e.g., subjects with no diseases contraindicating their dental treatment at KAU).
Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding that required urgent treatment
Non-smoker.
Patients who have opposing teeth and no missing posterior or canine teeth in all quadrants (except third molars).
Exclusion Criteria:
Have any known disease and would not allow the patient to be treatment planned for any procedures in the KAU clinics (e.g., severe anemia, low white blood cell count (Absolute Neutrophil Count (ANC) less than 1500, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates, endocrine-induced bone diseases (e.g. hyperparathyroidism), immunosuppressive therapy).
Have limited mental capacity and unable to give informed consent.
Be a pregnant or lactating female (self-reported)
Have untreated malignant neoplasm.
Individuals opposed to participate in the study.
If a patient has a crown which will not be able to assess the caries boarder and cementoenamel junction.
if a patient has a gagging reflex or inability to open his/her mouth.
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images
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