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Trial registered on ANZCTR


Registration number
ACTRN12618000780257
Ethics application status
Approved
Date submitted
17/02/2018
Date registered
9/05/2018
Date last updated
9/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of Different Viruses in Patients with Acute Tooth Pain
Scientific title
Detection of Humanherpes Virus-8, Human Cytomegalovirus, and Epstein-Barr Virus in Teeth with Symptomatic Irreversible Pulpitis using the Polymerase Chain Reaction Technique
Secondary ID [1] 294077 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Irreversible Pulpitis 306637 0
Condition category
Condition code
Infection 305739 305739 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 306384 306384 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detection of Humanherpes Virus-8, Human Cytomegalovirus, and Epstein-Barr Virus in Teeth with Symptomatic Irreversible Pulpitis using the Polymerase Chain Reaction Technique
The species and amount of the pathogens, as well as their relationship with each other and the host immunity, can define the variability of clinical symptoms. Therefore, specifying the different microorganisms and their role in endodontic diseases is important to develop novel medicaments.
The microbiological samples were obtained from 20 teeth with symptomatic irreversible pulpitis (Group 1).The samples were collected using a sterile paper point from the bleeding pulp chambers of the teeth during the endodontic treatment. The collection protocol of pulp specimens was as follows: After rubber-dam isolation, the crown surface, rubber-dam and clamps were rinsed with 30% H2O2 for 30 s, 2.5% NaOCl for 30 s, and 5% sodium thiosulfate for 30 s. Access cavity was prepared with a sterile bur used in high speed. The same disinfection protocol was used for the dentine just before entering the pulp chamber. When the bleeding pulp was exposed, blood samples were collected with a sterile #30 paper point (DiaDent Europe B.V., Almere, the Netherlands) held in the pulp chamber for 30 s, and then transferred to a sterile Eppendorf tube, and then stored at -20° C.
.The sample collection is an easy procedure for an endodontist. All endodontists involved in this study have experience for over three years. The endodontist collected the sample and completed the root canal treatment of volunteer patients in single visit. The procedure was carried out in Marmara University Faculty of Dentistry and all sample collections were completed in one visit.
Intervention code [1] 300348 0
Diagnosis / Prognosis
Intervention code [2] 300396 0
Early detection / Screening
Comparator / control treatment
Control group consisted of 20 orthodontically extracted healthy teeth in accordance with the inclusion criteria.
Control group
Active

Outcomes
Primary outcome [1] 304816 0
EBV presence as determined using PCR analysis completed on blood samples
Timepoint [1] 304816 0
Immediately after the PCR analysis
Primary outcome [2] 304891 0
HCMV presence as determined using PCR analysis completed on blood samples
Timepoint [2] 304891 0
Immediately after the PCR analysis
Primary outcome [3] 305504 0
HHV-8 presence as determined using PCR analysis completed on blood samples
Timepoint [3] 305504 0
Immediately after PCR analysis
Secondary outcome [1] 345511 0
Sensitivity to percussion prior to the root canal treatment assessed using a four point Verbal Rating Scale (no pain, low pain, moderate pain, severe pain)
Timepoint [1] 345511 0
Prior to the root canal treatment

Eligibility
Key inclusion criteria
• Individuals in good health without severe systemic diseases (American Society of Anesthesia I and II),
• Individuals without antibiotic or antiherpetic medication use in the last two months
• Vital teeth in acute conditions diagnosed with symptomatic irreversible pulpitis
• Radiographically normal periapical tissues
• Teeth with a probing depth of less than 4 mm and with no periodontal problems
• Teeth without pulp exposure due to caries or trauma
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals who doesn't provide American Society of Anesthesia I and II criteria
• Individuals with antibiotic or antiherpetic medication use in the last two months
• Devital teeth
• Radiographically visible periapical diseases
• Teeth with a probing depth of more than 4 mm and periodontal problems
• Teeth with pulp exposure due to caries or trauma

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/08/2015
Date of last participant enrolment
Anticipated
Actual
25/09/2015
Date of last data collection
Anticipated
Actual
25/09/2015
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 9593 0
Turkey
State/province [1] 9593 0

Funding & Sponsors
Funding source category [1] 298708 0
University
Name [1] 298708 0
Marmara University
Country [1] 298708 0
Turkey
Primary sponsor type
Individual
Name
Gülgün Cansu Öztürk
Address
Basibüyük Mahallesi, Basibüyük Yolu Marmara Üniversitesi Basibüyük Saglik Yerleskesi 9/3, 34854 Basibüyük - Maltepe/Maltepe/Istanbul
Country
Turkey
Secondary sponsor category [1] 297878 0
Individual
Name [1] 297878 0
Yildiz Garip Berker
Address [1] 297878 0
Basibüyük Mahallesi, Basibüyük Yolu Marmara Üniversitesi Basibüyük Saglik Yerleskesi 9/3, 34854 Basibüyük - Maltepe/Maltepe/Istanbul
Country [1] 297878 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299655 0
Istanbul University Faculty of Dentistry Ethical Commitee
Ethics committee address [1] 299655 0
Istanbul Tip Fakültesi Hastanesi
Bezm-i Alem Sokak
34093 Fatih Istanbul
Turkey
Ethics committee country [1] 299655 0
Turkey
Date submitted for ethics approval [1] 299655 0
10/03/2015
Approval date [1] 299655 0
17/03/2015
Ethics approval number [1] 299655 0
1500058975

Summary
Brief summary
Acute tooth pain is commonly related to the inflammation of the pulp tissue inside the root canal, referred as 'symptomatic irreversible pulpitis (SIP)'. The studies revealed that beside the bacteria; viruses and other microorganisms can also cause SIP. There are only few studies in the literature addresing the presence of viruses in the inflamed pulp tissue. Identifying different microorganisms in the pulp tissue can result in a more targeted medication use for the treatment of SIP. In this study, we are going to collect samples from root canals and analyze them with molecular biologic techniques.. The study and control groups will consist of 20 teeth with SIP and 20 teeth with orthodontic extraction indication, respectively. The pulp samples from the study group will be collected during the root canal treatment with a paper-point. The pulp samples from the control group will be collected after the extraction. The samples will be analyzed using polymerase chain reaction for the presence of the viruses.
Trial website
Trial related presentations / publications
Li H, Chen V, Chen Y, Baumgartner JC, Machida CA. Herpesviruses in endodontic pathoses: association of Epstein-Barr virus with irreversible pulpitis and apical periodontitis. J Endodont. 2009;35: 23-29.
Public notes

Contacts
Principal investigator
Name 81190 0
Dr Gülgün Cansu Öztürk
Address 81190 0
Yeni Yüzyil University, Faculty of Dentistry, Sütlüce Mahallesi, Binektasi Sokak, No:10 Beyoglu / Istanbul
Country 81190 0
Turkey
Phone 81190 0
+90 533 2343349
Fax 81190 0
Email 81190 0
[email protected]
Contact person for public queries
Name 81191 0
Dr Gülgün Cansu Öztürk
Address 81191 0
Yeni Yüzyil University, Faculty of Dentistry, Sütlüce Mahallesi, Binektasi Sokak, No:10 Beyoglu / Istanbul
Country 81191 0
Turkey
Phone 81191 0
+90 533 2343349
Fax 81191 0
Email 81191 0
[email protected]
Contact person for scientific queries
Name 81192 0
Dr Gülgün Cansu Öztürk
Address 81192 0
Yeni Yüzyil University, Faculty of Dentistry, Sütlüce Mahallesi, Binektasi Sokak, No:10 Beyoglu / Istanbul
Country 81192 0
Turkey
Phone 81192 0
+90 533 2343349
Fax 81192 0
Email 81192 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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