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.: PACTR201304000530301 Date of Approval: 12/04/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title saving immature teeth
Official scientific title Comparative Study between Revitalization of Necrotic Immature Permanent Anterior Teeth with and without Platelet Rich Fibrin: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Revitalization used blood clot to act as a scaffold with different growth factors to aid the in-growth of new tissue in to the empty canal space. Hargreaves et al 2008 reported that platelet-rich plasma satisfies many of these criteria.This study is conducted to Compare the rate of root formation in revitalization with and without platelet rich fibrin (PRF) for treatment of necrotic immature permanent anterior teeth.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RNIPAT
Disease(s) or condition(s) being studied chronic abscess,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2013
Actual trial start date
Anticipated date of last follow up 01/01/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 22
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 Each participant will be randomly assigned following simple randomization procedure by using closed white envelops (22 closed white envelopes) which assign the group to be followed. Those closed envelops includes 11 paper charts (fig. 2) and 11 paper charts (fig. 3), which are folded three times not to show its contents to assure random assignment. WITH PRF Figure 1: Paper inside the closed white envelopes WITHOUT PRF Figure 2: Paper inside the closed white envelopes Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Regenerative endodontic treatment by inducing bleeding and packing of platelet rich fibrin once 11
Control Group Regenerative endodontic treatment by inducing bleeding only once 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients are free from any medical, physical or mental handicapping condition. ¿ Patient's age between 7-15 years old. ¿ Necrotic immature permanent anterior teeth with open apex with apical periodontitis / abscess. ¿ Positive patient's acceptance for participation in the study. ¿ Radiographic evidence of external or internal root resorption. ¿ Any known sensitivity or adverse reactions to the antibiotics in the tri-mix. 7 Year(s) 15 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 01/05/2013 scientific research ethics committee
Ethics Committee Address
Street address City Postal code Country
el-manial , cairo university, infront of the musiam cairo 00202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of root development (mm/6month) 0 day (appointment at which bleeding is induced) 6 months 12 months
Secondary Outcome recurrence of pain baseline (first visit) second visit 1 month later 3 months 6 months 9 months 1 year
Secondary Outcome recurrence of swelling baseline (first visit) second visit 1 month later 3 months 6 months 9 months 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University, El-kasr El-Einy, Pediatric dentistry department El-manial, infront of the musiam Cairo 00202 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
rasha adel ragab (the researcher) 8138, 9 street, el-mokattam, cairo cairo 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor rasha adel ragab (the researcher) 8138, 9 street, el-mokattam, cairo cairo 00202 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
rasha adel ragab (the researcher) 8138, 9 street, el-mokattam, cairo cairo 00202 Egypt
Amr Ezzat Abdellatif pediatric dentistry department, cairo university, el-kasr el-einy cairo 00202 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasha Adel rashaadelragab@gmail.com 0020201111511145 8138, 9 street, el-mokattam, cairo
City Postal code Country Position/Affiliation
cairo 00202 Egypt Assistant lecturer, cairo university
Role Name Email Phone Street address
Public Enquiries Amr Ezzat amrezzat03@yahoo.com 0020201001640971 pediatric dentistry department, cairo university, el-kasr el-einy
City Postal code Country Position/Affiliation
cairo 00202 Egypt Associate Proffessor, cairo university
Role Name Email Phone Street address
Scientific Enquiries Rasha Adel rashaadelragab@gmail.com 0020201111511145 8138, 9 street, el-mokattam, cairo
City Postal code Country Position/Affiliation
cairo 00202 Egypt Assistant lecturer, cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information