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.: PACTR201602001466307 Date of Approval: 10/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical evaluation of direct resin composite restorations of endodontically treated molars using dual cured self-adhesive system with bulk fill compo
Official scientific title Clinical evaluation of direct resin composite restorations of endodontically treated molars using dual cured self-adhesive system with bulk fill composite versus incremental packing technique.
Brief summary describing the background and objectives of the trial To evaluate the clinical success of the restorations of the endodontically treated molars with remaining 3 walls restored using dual cured self-etch adhesives and bulk fill resin composite at a time interval of 3 ,6 and 12 months.
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 01/03/2016
Actual trial start date
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group xtra base by VOCO once 1 year bulk fill resin composite 50
Control Group Grandio by Voco once 1 year Incremental packing composite 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients with endodotically treated molars with remaining three walls. 2) Patients who need root canal treatment for molars with proximal caries. 3) Good oral hygiene. 4) Medically free adult patients. Teeth with fractured roots. 2) Teeth with severe dilacerations. 3) Teeth with lesions or fractures. 4) Teeth with visible cracks. 5) Teeth with internal or external root resorption. 6) Teeth with calcified. root canals 7) Teeth with mobility 8) Teeth with undermined enamel walls. 9) poor oral hygiene. 20 Year(s) 50 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
No 28/02/2016 Ethical Committee of Faculty of Oral and Dental Medicine.
Ethics Committee Address
Street address City Postal code Country
11 saraya el manyal cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome USPHS criteria for clinical success of restorations 3 months 6 months 1 year
Primary Outcome Retention 3 months, 6 months, 1 year
Primary Outcome Color match 3 months, 6 months, 1 year
Primary Outcome Marginal discoloration 3 months, 6 months, 1 year
Primary Outcome Marginal adaptation 3 months, 6 months, 1 year
Primary Outcome Secondary caries 3 months, 6 months, 1 year
Primary Outcome Surface texture 3 months, 6 months, 1 year
Primary Outcome Anatomic form 3 months, 6 months, 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Outpatient Clinics of Conservative dentistry department in Faculty of Oral and Dental Medicine saraya el manyal cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and dental medicine ,cairo university 11 saraya elmanyal st. cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nancy Helmy
Mohamed Refaat
Ahmed saggan
Nancy Helmy 11 saraya elmanial, Kasr El Ainy Cairo 11553 Egypt
Mohamed Refaat 11 saraya elmanial, Kasr El Ainy Cairo 11553 Egypt
Ahmed saggan 11 saraya elmanial, Kasr El Ainy Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed refaat ahmed.refaat@dentistry.cu.edu.eg 011 46 46 46 96 15 sudan street
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries mohamed fouad mfouad25877@yahoo.com 01229157840 2 abdelwahab selim st. , maadi
City Postal code Country Position/Affiliation
Egypt lecturer , faculty of oral and dental medicine ,cairo university
Role Name Email Phone Street address
Scientific Enquiries mohsen abi elhassan mohsen.abielhassan@dentistry.cu.edu.eg 01003805500 11 saraya elmanial, kasr el ainy
City Postal code Country Position/Affiliation
cairo 11553 Egypt professor,faculty of oral and dental medicine ,cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information