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.: PACTR201711002568284 Date of Approval: 28/08/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical and Radiographic Evaluation of Vital Pulpotomy in Primary Molar Using Antioxidant Mix as A Novel Pulotomy Medication Versus Formcresol:
Official scientific title Clinical and Radiographic Evaluation of Vital Pulpotomy in Primary Molar Using Antioxidant Mix as A Novel Pulotomy Medication Versus Formcresol
Brief summary describing the background and objectives of the trial This study aims to evaluate the clinical and radiographic success rate of antioxidant mix as a pulpotomy agent
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,pulpotomy in vital primary molars
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/07/2016
Actual trial start date 20/08/2016
Anticipated date of last follow up 20/07/2017
Actual Last follow-up date 20/08/2017
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Completed
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 randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Commercially available antioxidant, namely Centrum 3,6,9 multivitamin and mineral which will be used in pulp capping 26
Control Group formocresol 3 ,6, ,9 mateial used for mumification of pulp 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Tooth with no spontaneous pain ¿ At least two-thirds of the root length is still present ¿ No sign of internal or other kind root resorption ¿ Hemorrhage from the amputation site is easy to control. ¿ Patients with systemic diseases )congenital or rheumatic heart disease ,hepatitis ,nephritis ,tumor ,cyclic neutropenia, leukemia and children on long term corticosteroid therapy)as they shouldn¿t be subjected to the possibility of acute infection resulting from pulp therapy aside from the fact the pulp might not possess normal regeneration power . ¿ Un-cooperative patients ¿ Unrestorable teeth ( Grossly broken down teeth that have decay extending way under the gingiva in which restoration would be impossible following pulp treatment) 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 26/05/2015 Ethics Committee, Faculty of dentistry -Cairo University
Ethics Committee Address
Street address City Postal code Country
11 Al Saraya, Al Manial, Giza cairo 11311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain 3 months 6 months 9 months
Secondary Outcome swelling pain on perrcusion and mobility 3 6 9 months
Secondary Outcome 5. Adverse radiographic findings (eg. internal or external root resorption or other pathologic changes): 3 6 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of dentistry, Cairo Universtity 11 Al Saraya, Al Manial, Giza Cairo 11311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Pediatric and Community Dentistry, Faculty of Oral and Dental medicine, Cairo University- Egypt. 11 Al Saraya, Al Manial, Giza cairo 11311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Department of Pediatric and Community Dentistry, Faculty of Oral and Dental medicine, Cairo University- Egypt. 11 Al Saraya, Al Manial, Giza cairo 11311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator randa youssef Randa.youssef@yahoo.com 01222272010
City Postal code Country Position/Affiliation
cairo 11311 Egypt Assistant professor
Role Name Email Phone Street address
Principal Investigator amr ezzat Amrezzat03@gmail.com 01001640971 11 Al Saraya, Al Manial, Giza
City Postal code Country Position/Affiliation
cairo 11311 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries randa youssef Randa.youssef@yahoo.com 01222272010 11 Al Saraya, Al Manial, Giza
City Postal code Country Position/Affiliation
cairo 11311 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries randa youssef Randa.youssef@yahoo.com 01222272010 11 Al Saraya, Al Manial, Giza
City Postal code Country Position/Affiliation
cairo 11311 Egypt Assistant professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information