- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04341636
A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jeddah, Saudi Arabia
- King Abdulaziz University , Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vertical bitewing
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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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 . |
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Active Comparator: horizontal bitewing
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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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 . |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Caries Detection
Time Frame: baseline and 15 minutes
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Count number of teeth with caries
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baseline and 15 minutes
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Level of Bone Loss
Time Frame: baseline and at 15 minutes
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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.
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baseline and at 15 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0530517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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