Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201604001600174 Date of Approval: 23/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laboratory evaluation of a self-adhering flowable composite resin as a pit and fissure sealant
Official scientific title Laboratory evaluation of a self-adhering flowable composite resin as a pit and fissure sealant
Brief summary describing the background and objectives of the trial Current dentistry privileges minimal intervention methods, among which pit and fissure sealing is widely accepted approach for preventing occlusal caries. Recently, innovative resin-based material were introduced to market combining the properties of self-adhesion and flowabilitiy. This trial aimed to evaluate the shear bond strength and microleakage of Vertise Flow (a self-adhering flowable composite) and compare it with conventional sealant used with self-adhesive bonding system.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 31/05/2016
Actual Last follow-up date 31/05/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vertise flow-shear bond strength Incrementally applied 3mm cylinder to flate buccal enamel surface Force was applied with rate of 1mm/min using universal testing machine at interface between material and tooth surface Shear bond strength was measured by determining the force needed to dislodge the sealant from enamel 15
Experimental Group Vertise flow - microleakage Occlusal pits and fissures were sealed Specimen were thermocycled for 500 cycles and then stained Stained samples were sectioned, examined under microscope and dye penetration for each was then scored and recorded 15
Control Group Adper L Pop+ Clinpro sealant_shear bond strength Adper l pop was applied and Clinpro sealant Incrementally applied 3mm cylinder to flate buccal enamel surface Force was applied with rate of 1mm/min using universal testing machine Shear bond strength was measured by determining the force needed to dislodge the sealant from enamel 15 Active-Treatment of Control Group
Control Group Adper L Pop+ Clinpro sealant - microleakage Occlusal pits and fissures were sealed Specimen were thermocycled for 500 cycles and then stained Stained samples were sectioned, examined under microscope and dye penetration for each was then scored and recorded 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
presence of deep and retentive pits and fissures. No caries No previous fillings 12 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/09/2014 Faculty of Dentistry, Alexandria University IRB
Ethics Committee Address
Street address City Postal code Country
Chambillion st. Azarita, Alexandria 21526 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Shear bond strength After 24hr stored100% humidity at 37°C prior to shear bond strength testing using universal testing machine
Primary Outcome Microleakage test after thermocycling between 5±2°C and 55±2°C for 500 cycles prior to staining
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Pediatric Dentistry and Dental Public Health, Alexandria university chambillion st. Azarita, Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Pediatric Dentistry and Dental Public Health, Alexandria university chambillion st. Azarita, Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of dentistry, Alexandria university, Egypt chambillion st. Azarita, Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nadia Aziz Wahba chambillion st. Azarita, Alexandria 21526 Egypt
Dalia Mamdouh Talaat chambillion st. Azarita, Alexandria 21526 Egypt
Bassem Elmallakh chambillion st. Azarita, Alexandria 21526 Egypt
Nour Mohamed abdelfattah owida chambillion st. Azarita, Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadia Wahba drnadiawahba@gmail.com +2012284000520 305 Elhorria Street, Cleopatra
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor, Head of Depratment
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Dalia Talaat daliatalaat7576@hotmail.com +201221037275 134 Abdel-Salam Aref St, Zezenia
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Associate Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information