Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001670167
Ethics application status
Approved
Date submitted
29/09/2019
Date registered
28/11/2019
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is the tooth type playing a role in the accuracy of detecting proximal caries?
Scientific title
The Relation between tooth type and the accuracy of detecting proximal caries surface by using conventional radiography
Secondary ID [1] 298994 0
none
Universal Trial Number (UTN)
U1111-1238-5217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 314000 0
Condition category
Condition code
Oral and Gastrointestinal 312389 312389 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who attended the Faculty of Dentistry at Damascus University, before receiving treatment, were consecutively screened. An experienced investigator will screen all possible candidates for inclusion and exclusion criteria. Patients that meet the inclusion criteria will be seated on a dental unit and then a thorough oral prophylaxis will be conducted using a bristle brush and pumice paste.

Including criteria:
Patients whose scored above (14) by using a DIAGNOdent device (Kavo®, Biberach, Germany) were selected and readings recorded.

Exclusion
Patients criteria:
Patients with severe systematic diseases
Tooth related criteria
Surfaces which presence of frank approximal cavitated caries lesions (e.g. The absence of a marginal ridge), restorations or crowns and the absence of an adjacent tooth.

The work has been divided into two sections,
First,
Radial examination, conventional method “F-speed film was used (Insight, Eastman Kodak, Rochester, NY, USA) and the X-ray unit (X-Mind DC, Acteon Group,La Ciotat,France) was set in 60 kV and 7mA with 0.139 s exposure time. With a bite-wing holder (The Super-Bite X-ray holder, Kerr X-ray holders, USA) and a paralleling long cone technique. ” Films processed by X-ray film automatic processor

The scoring system suggested by Marthaler was used. The frequency distribution of surfaces with radiolucency in the outer half of the enamel suggested collapsing original scores 1 and 2 (radiolucency in the outer and inner half of the enamel, respectively) into one group.
Thus, the approximal surfaces were scored as follows:
0 = no radiolucency; 1 = radiolucency in the enamel; 2 = radiolucency in the outer half of dentine; and 3 = radiolucency in the inner half of dentine.

Second
Temporary separation was carried out for selected approximal surfaces using orthodontic rubber rings (American Orthodontics, USA), which were placed around the contact points for 7 days.

A laser fluorescence device, DIAGNOdent pen (KaVo, Biberach, Germany), with an approximal tip (Probe tip 1) was used for laser fluorescence examination according to the manufacturer’s instructions
group 0 = 0-13 healthy tooth / group 1 =14-29 Enamel caries / group 2=30< dentine caries

Observers
Three experienced dentists from operative and oral medicine/radiographic departments were assessed the entire research samples and they were blinded from DIAGNOdent results. Each observer evaluated individually all research samples.
every each session, observers are received explanation of score’s classification.
All radiographic films were read using subdued lightning box and all samples were observed in a quiet room with dimmed lighting.
Intervention code [1] 315293 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321073 0
Assessment of dental approximal caries using conventional radiography
Timepoint [1] 321073 0
One week after the first appointment.
Secondary outcome [1] 377292 0
nil
Timepoint [1] 377292 0
nil

Eligibility
Key inclusion criteria
Including criteria
Patients whose scored above (14) by using a DIAGNOdent device (Kavo®, Biberach, Germany) were selected and readings recorded.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion
Patients criteria:
patents with severe systematic diseases
tooth related criteria
surfaces which presence of frank approximal cavitated caries lesions (e.g. the absence of a marginal ridge), restorations or crowns and the absence of an adjacent tooth.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 21891 0
Syrian Arab Republic
State/province [1] 21891 0
Damascus

Funding & Sponsors
Funding source category [1] 303532 0
University
Name [1] 303532 0
Damascus University
Country [1] 303532 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Dental College, Damascus University, Al-Mazzeh St., Damascus, Syria.
Country
Syrian Arab Republic
Secondary sponsor category [1] 303598 0
None
Name [1] 303598 0
null
Address [1] 303598 0
null
Country [1] 303598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304059 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 304059 0
Ethics committee country [1] 304059 0
Syrian Arab Republic
Date submitted for ethics approval [1] 304059 0
Approval date [1] 304059 0
19/09/2019
Ethics approval number [1] 304059 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95682 0
Dr Laith alsabek
Address 95682 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 95682 0
Syrian Arab Republic
Phone 95682 0
+963937178467
Fax 95682 0
Email 95682 0
[email protected]
Contact person for public queries
Name 95683 0
laith alsabek
Address 95683 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 95683 0
Syrian Arab Republic
Phone 95683 0
+963937178467
Fax 95683 0
Email 95683 0
[email protected]
Contact person for scientific queries
Name 95684 0
laith alsabek
Address 95684 0
Dental College, Damascus University,
Al-Mazzeh St.
Damascus, PO Box 30621
Country 95684 0
Syrian Arab Republic
Phone 95684 0
+963937178467
Fax 95684 0
Email 95684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5138Study protocol  [email protected]
5140Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.