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.: PACTR201304000531329 Date of Approval: 14/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical evaluation of the effect of MTAD versus Propolis irrigation on necrotic primary teeth in children
Official scientific title Clinical evaluation of the effect of MTAD versus Propolis
Brief summary describing the background and objectives of the trial Effective irrigation is essential in canal debridement, because instrumentation alone is insufficient, and inadequate canal debridement can leads to a decrease in successful outcomes. (Howard et al, 2011) The aim of this study is to investigate the effect of Propolis irrigation versus MTAD (Mixture of tetracycline isomer, an acid, and a detergent) irrigation on: 1-Pain assessment. 2-Count of intracanal bacteria 3-Size of periapical radiolucency.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied canal debridement,Oral Health,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2013
Actual trial start date 01/05/2013
Anticipated date of last follow up 01/05/2014
Actual Last follow-up date 01/05/2014
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Recruiting
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 using computer generated random numbers using closed envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MTAD 5ml used once in irrigation 5 minutes Mixture of tetracycline isomer, an acid, and a detergent 50 Active-Treatment of Control Group
Experimental Group Propolis irrigation 5 ml used once in irrigation 5 minutes It is composed of resin and balsams , essential oils, pollen and other constituents which are amino acids, minerals, vitamins A, B complex and E and the highly active bio-chemical substance known as bioflavinenoid 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Presence of clinical signs or symptoms suggesting a non-vital tooth, such as localized swelling, sinus, tenderness on percussion or slight mobility, or periapical or furcal radiolucency. 2-Restorable tooth. 3-Patient cooperation and parent acceptance to be included in this study and to attend regularly for follow up (concent) 1-Presence of advanced physiologic or pathologic root resorption. 2- presence of any systemic disease which would contraindicate pulp therapy e.g. infective endocarditis 4 Year(s) 8 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 07/03/2013 Ethics committee of the National Research Centre
Ethics Committee Address
Street address City Postal code Country
National Research Centre - Al bohoth St Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain at 0 day, 3months, 6 months, 9months and 1 year
Secondary Outcome bacterial count 1- Before irrigation 2- immediatly after irrigation 3- 48 hours after irrigation
Secondary Outcome size of perapical radiolucency preoperative immediatly postoperative( at 0 day) at 3months at 6 months at 9 months and at 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Evidance based committee al kasr al ainy st cairo Egypt
Faculty of oral and dental medicine cairo university al kasr al ainy st Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Centre
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine, Cairo University al kasr al ainy st Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Rasha Farouk Sharaf 1 Mohamed salem st, Pyramids street. Cairo 12211 Egypt
Prof Dr.Sherine Ezz El-Din Taha Cairo Egypt
Prof Dr. Amr Ezzat Cairo Egypt
Prof Dr. Nourhan El Dokki Cairo Egypt
Prof Dr. Mohamed Abo El Yazeed Cairo Egypt
Prof Dr.Sherine Ezz El-Din Taha Al nozha street - masr el gedeeda Cairo 1112 Egypt
Prof Dr. Mohamed Abo El Yazeed street no. 9 Maadi Cairo 12211 Egypt
Prof Dr. Nourhan El Dokki El nasr street - Nasr city Cairo 11221 Egypt
Prof Dr. Amr Ezzat El nabawy al mohandes street, Agouza Cairo 11221 Egypt
Prof Dr.Sherine Ezz El-Din Taha Al nozha street - masr el gedeeda Cairo 1112 Egypt
Prof Dr. Mohamed Abo El Yazeed street no. 9 Maadi Cairo 12211 Egypt
Prof Dr. Nourhan El Dokki El nasr street - Nasr city Cairo 11221 Egypt
Prof Dr. Amr Ezzat El nabawy al mohandes street, Agouza Cairo 11221 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Prof Dr. Sherine Ezz El Din shero2000y@yahoo.com 01005245303 Al nozha street - masr el gedeeda
City Postal code Country Position/Affiliation
Cairo 1112 Egypt professor of Pediatric and Community Dentistry
Role Name Email Phone Street address
Public Enquiries Prof Dr Nourhan El Dokki sonysony211@gmail.com 01001500723 El nasr street - Nasr city
City Postal code Country Position/Affiliation
Cairo 11221 Egypt Assoc. Prof. of Pediatric and Community Dentistry
Role Name Email Phone Street address
Scientific Enquiries Dr. Rasha sharaf rasha_sharaf@hotmail.com 01005022435 1 Mohamed salem st, Pyramids street.
City Postal code Country Position/Affiliation
Cairo 12211 Egypt Researcher Assistant in National Research Centre
REPORTING
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