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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: www.pactr.org

Trial no.: PACTR201304000530301 Date registered: 2013/04/12
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
Purpose of the trial Treatment
Anticipated trial start date 2013-01-01
Actual trial start date
Anticipated date of last follow up 2014-01-01
Actual date of last follow up
Anticipated target sample size (number of participants) 40   
Actual target sample size (number of participants) 22   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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 Min age Max 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 Years 15 Years 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 2013/05/01 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 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 Fax
Principal Investigator Dr Rasha Adel rashaadelragab@gmail.com 0020201111511145
Street address City Postal code Country Position / Affiliation
8138, 9 street, el-mokattam, cairo cairo 00202 Egypt Assistant lecturer, cairo university
Role Name Email Phone Fax
Public Enquiries Prof Amr Ezzat amrezzat03@yahoo.com 0020201001640971
Street address City Postal code Country Position / Affiliation
pediatric dentistry department, cairo university, el-kasr el-einy cairo 00202 Egypt Associate Proffessor, cairo university
Role Name Email Phone Fax
Scientific Enquiries Dr Rasha Adel rashaadelragab@gmail.com 0020201111511145
Street address City Postal code Country Position / Affiliation
8138, 9 street, el-mokattam, cairo cairo 00202 Egypt Assistant lecturer, cairo university