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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vertical bitewing | Experimental | 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 ). |
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| horizontal bitewing | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bitewing X ray | Radiation | 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Caries Detection | Count number of teeth with caries | baseline and 15 minutes |
| Level of Bone Loss | All of the bitewing radiographs will be evaluated for bone loss measurements. The steel wire will be used to determine the magnification factor . 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 from the CEJ to the bone crest. | baseline and at 15 minutes |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University , Faculty of Dentistry | Jeddah | Saudi Arabia |
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20 participants were randomized.
20 patients were screened for eligibility at the dental clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Vertical Bitewing, Then Horizontal Bitewing | Participants first received vertical bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received horizontal bitewing in the same day for 15 minutes. 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 ). |
| FG001 | Horizontal Bitewing, Then Vertical Bitewing | Participants first received horizontal bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received vertical bitewing in the same day for 15 minutes. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (15 Minutes) |
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| Washout (10 Minutes) |
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| Second Intervention (15 Minutes) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Vertical Bitewing, Then Horizontal Bitewing | Participants first received vertical bitewing. After a washout period of 15 min, they then received Horizontal bitewing. |
| BG001 | Experimental: Horizontal Bitewing, Then Vertical Bitewing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caries Detection | Count number of teeth with caries | Posted | Mean | 95% Confidence Interval | teeth | baseline and 15 minutes | Teeth | Teeth |
|
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vertical Bitewing | Participants first received vertical bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received horizontal bitewing in the same day for 15 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zuhair Natto | King Abdulaziz University | 9666943899 | znatto@kau.edu.sa |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2020 | Apr 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
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|
| NOT COMPLETED |
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| NOT COMPLETED |
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Participants first received horizontal bitewing. After a washout period of 15 min, they then received vertical bitewing. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of radiography | Mean | Standard Deviation | x ray |
|
| Participants |
|
| Teeth |
|
|
| Primary | Level of Bone Loss | All of the bitewing radiographs will be evaluated for bone loss measurements. The steel wire will be used to determine the magnification factor . 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 from the CEJ to the bone crest. | Posted | Mean | Standard Deviation | mm of bone loss | baseline and at 15 minutes | Teeth | Teeth |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Horizontal Bitewing | Participants first received horizontal bitewing in one day for 15 minutes . After a washout period of 10 minutes, they then received vertical bitewing in the same day for 15 minutes. | 0 | 20 | 0 | 20 | 0 | 20 |
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