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.: PACTR201502001032409 Date of Approval: 09/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A novel way to treat immature teeth
Official scientific title pulp revascularization using platelet rich plasma versus conventional blood clot technique in necrotic immature teeth to promote periapical healing and continued root development: Randomized clinical trial
Brief summary describing the background and objectives of the trial background:Dental caries and trauma to incompletely-developed, young, immature, permanent teeth are the most common causes of pulp necrosis which causes cessation of further tooth development. Pulpal necrosis in an immature tooth with an open apex can have devastating consequences for patients and presents a distinctive challenge for the endodontist. Immature teeth have open and often divergent apices that are not suitable for complete debridement and obturation with traditional materials. In addition, these teeth are susceptible to fracture after treatment because of their thin walls.For a tooth with an immature apex and necrotic pulp, the ideal outcome would be to regenerate pulp tissue into a canal capable of promoting continuation of normal root development. Before 2004, clinicians used traditional apexification procedures, where a hard-tissue barrier is induced apically, or the use of apical barriers to treat immature teeth with pulpal necrosis. In 2004, Banchs and Trope were the first to introduce a new treatment procedure for the management of the open apex called ¿revascularization¿ as a case report. . The use of PRP as an alternative source for a fibrin clot might have several advantages, including increased concentration of growth factors and removal of erythrocytes that would be expected to undergo necrosis shortly after clot formation. objective: The objective of this trial is to evaluate novel regenerative techniques, utilizing plasma preparations rich in platelets, in the management of young, permanent teeth through revascularization of non-vital, weakened, immature teeth to ensure continued root development through regaining vital tissue, hopefully pulpal, containing hard-tissue forming cells in the pulp space to allow for increased root length and canal wall thickness that can help the tooth attain higher fracture resistance to maintain its function in the oral cavity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied immature necrotic permanent teeth,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2015
Actual trial start date 01/10/2015
Anticipated date of last follow up 01/10/2017
Actual Last follow-up date 01/10/2017
Anticipated target sample size (number of participants) 26
Actual target sample size (number of participants) 26
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Blood clot Revascularization Once Blood clot inside the root canal 13 Active-Treatment of Control Group
Experimental Group Platelet rich plasma Revascularization Once PRP scaffold inside the root canal 13
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases. - Patient's age ranges between 7 and 60 years old. - Patients having non-vital, immature, permanent anterior or premolar teeth, with or without radiographic evidence of apical periodontitis. - Positive patient/Guardian compliance for participation in the study. ¿Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial. ¿Non-restorable coronal portion of teeth involved in the trial. ¿Radiographic evidence of external or internal root resorption. 7 Year(s) 60 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 13/07/2015 the Institutional review board of research ethics committee of the Faculty of Oral and Dental Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
1 el saraya street, el manial cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome resolution of infection 48 hours 72 hours 7 days
Secondary Outcome root lengthening 3 months 6 months 9 months
Secondary Outcome apical closure 3 months 6 months 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of endodontics, faculty of oral and dental medicine, cairo university 1 el saraya street, el manial cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 170 ashgar neighborhood, 6 october giza 12566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor department of endodontics, faculty of oral and dental medicine, cairo university 1 el saraya street, el manial cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Khaled mohamed ezzat 1 el saraya street, el manial cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El-Sheshtawy ahmed.shawky@dentistry.cu.edu.eg +201007577711 170 el ashgar neibgborhood, 6 october
City Postal code Country Position/Affiliation
giza 12566 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries hassan ahmed hassan.ahmed@dentistry.cu.edu.eg +201015009014 1 el saraya street, el manial
City Postal code Country Position/Affiliation
cairo 11553 Egypt executive
Role Name Email Phone Street address
Scientific Enquiries Khaled Ezzat prof.dr.khaledezzat@gmail.com +201222140180 1 el saraya street, el manial
City Postal code Country Position/Affiliation
cairo 11553 Egypt professor, head of department of endodontics
REPORTING
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