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.: PACTR201701001868213 Date of Approval: 14/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing 2 medications in management of necrotic pulp in primary molars
Official scientific title Evaluation of Postoperative Pain after Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial to compare 2 medications in treating necrotic primary molars in children one is gold standard and called calcium hydroxid iodofrom paste and the comarator is in innovative called 3-mixtatin , the objective is to treat hopless primary molars by the newly introduced material
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied necrotic primary molars
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 30/11/2016
Actual trial start date 01/12/2016
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date 01/09/2016
Anticipated target sample size (number of participants) 92
Actual target sample size (number of participants) 92
Recruitment status Not yet 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 The allocation sequence by random allocation software version 1.0,May 2004 will be generated on operator personal computer.select the number groups (2) then enter the name of each group (3-MIX-TATIN and METAPEX). Enter the sample size (82) and select Generate from the Sequence menu Each participant will be randomly assigned following simple randomization procedure by using shuffled closed white envelops(82) , which assign the number of the groups to be followed. Those closed envelops include (82) paper charts , which are folded eight times not to show its contents to assure allocation concealment. It will be withdrawn by parents or patient. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 3-mix-tatin once apllied one time triple mix antibiotics and simvastatin 46
Control Group calcium hydroxide iodoform once from day of application till extraction of teeth calcium hydroxide iodoform in a ready made preloaded syringe ready for placement . the paste will be used in necrotic pulp treated by LSTR technique 46 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Children age range from 5-8 years. ¿ Children free from any systemic diseases or medical problems. ¿ Primary molar with necrotic pulp, with pain, gingival abscess, fistula openings, or clinical mobility not exceeding grade two. ¿ Radiographic evidence of non-perforating internal resorption, external resorption not exceeding 1\3 of the root, furcation or periapical radiolucency. Exclusion criteria: ¿ Non-restorable molars or beyond repair, for example: decay reaches to bifurcation, a hard gingival margin cannot be established or infection cannot be eradicated by other mean(Balaji, 2007). ¿ Patient with known allergy to any type of antibiotics or anti-hyperlipidemia drugs. ¿ Patient on antibiotic therapy over the last 2 weeks. ¿ Patient with facial cellulitis or lymphadenopathy ¿ Lack of patient/parent compliance and cooperation. ¿ Refusal of participation or failure to obtain an informed consent 5 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 01/10/2016 ethics commitee, cairo university
Ethics Committee Address
Street address City Postal code Country
ssaray al manial, dentistry college, dean office cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative pain at 1 month pos operative 3rd motnth 6 month 9 month
Secondary Outcome mobility at the first visit 2nd visit at 3rd month 3rd visit at 6th month 4th visit at 9th month
Secondary Outcome sinus and fistula at 1st visit 2nd visit at 3rd month 3rd visit at 6th month 4th visit at 9th month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
peadiateric dentistry department, cairo university saray al manial, pediateric dentstry bulding, cairo 002 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 department of peadiatric dentistry, cairo UNIVERSITY saray al manial, pediateric dentstry bulding, cairo 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
department of peadiatric dentistry, cairo UNIVERSITY saray al manial, pediateric dentstry bulding, cairo 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dr amr ezzat ezzat amrezzat03@gamil.com 0201115082428 saay al manial cairo
City Postal code Country Position/Affiliation
cairo 002 Egypt supervisor
Role Name Email Phone Street address
Public Enquiries raadwa yousef crazy_dr4444@yahoo.com 010003590167
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Scientific Enquiries prof dr samah awad awad samah.awad@gamil.com 01062922285 pedodontic department, second floor, faculty of dentistry, cairo university
City Postal code Country Position/Affiliation
cairo 002 Egypt prof. of ppedodontics cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information