Clinical trial NCT04341636: 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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Dental Caries
Keywords: Radiography, Bitewing
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age.
2. 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).
3. Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding that required urgent treatment
4. Non-smoker.
5. Patients who have opposing teeth and no missing posterior or canine teeth in all quadrants (except third molars).

Exclusion Criteria:

1. 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).
2. Have limited mental capacity and unable to give informed consent.
3. Be a pregnant or lactating female (self-reported)
4. Have untreated malignant neoplasm.
5. Individuals opposed to participate in the study.
6. If a patient has a crown which will not be able to assess the caries boarder and cementoenamel junction.
7. if a patient has a gagging reflex or inability to open his/her mouth.

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Primary outcomes:
measure: Caries detection
timeFrame: 1 month
measure: Level of bone loss
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University , Faculty of Dentistry
Study officials:
References: