A Comparison of the Accurate Diagnosis of the Horizontal & Vertical Bitewing Images

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04341636
• Other study ID #: 0530517
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2020
• Est. completion date: February 2021

Study information

• Verified date: April 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Dental Caries
• Periodontal Diseases

Intervention

Radiation:
• Bitewing X ray
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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ).	1 month
Primary	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.	1 month