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.: PACTR201602001444180 Date of Approval: 26/01/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between two intracanal medicaments, calcium hydroxide and silver nano-particle
Official scientific title Intra-canal medicament containing silver nanoparticle versus calcium hydroxide intra-canal medicament in reducing post-operative pain and bacterial endotoxins (Randomized Clinical Trial)
Brief summary describing the background and objectives of the trial To compare the ability of intra-canal medicament containing silver nanoparticle versus calcium hydroxide intra-canal medication in reducing pain and level of endotoxins in necrotic pulp of permanent teeth with apical periodontitis. ¿ PICO approach: P: population ¿Patients diagnosed with necrotic pulp permanent teeth with apical periodontitis. I: intervention ¿Intra-canal medicament containing silver nanoparticle suspension (Nanotech) (polyethylene glycol will be used to formulate the preparation). C: control ¿Using calcium hydroxide (Meta paste, Meta company, Korea) as intra-canal medication. O:outcome A)Primary outcome: Post-operative pain. -Tool measurement:Numerical rating scale (Brunelli et al, 2010) -Unit measurement: ordinal B)Secondary outcome: Endotoxins quantification. -Tool measurement:Limulus Amebocyte Lysate assay (LAL) (QCL-1000, Lonza Company) -Unit measurement:EU/mL (Endotoxin Unit/ milliliter)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied ,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2016
Actual trial start date 20/02/2016
Anticipated date of last follow up 25/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomization is carried out by G.M. (assistant supervisor) by using a computer software. (http://www.random.org/). - Numbered papers will be packed in opaque closed envelopes by G.M., where the patient will pick up an envelope. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group silver nano particle intra-canal medication one week ¿ Intra-canal medicament containing silver nanoparticle suspension (Nanotech) (polyethylene glycol will be used to formulate the preparation). 17 Active-Treatment of Control Group
Control Group calcium hydroxide intra-canal medication one week calcium hydroxide (Meta paste, Meta company, Korea) as intra-canal medication. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
oAge between 18-55 years old. oMales or females. oPositive patient's acceptance to participate in the study. oSingle rooted maxillary or mandibular teeth with: ¿Non-vital response of pulp tissue. ¿Tenderness to percussion. ¿Slight widening of lamina-dura. oPatients aging more than 55 years old. (to have an identical group of patients with approximately same age (standardization). (Raju et al, 2014). oMedically compromised patients. (as medically compromised patients could experience pain simulating odontogenic pain which will affect the results according to Vickers & Cousins 2000). oPatients who had received antibiotic treatment during the last 3 months. (as it can decrease the micro-organisms which will affect the results, Seltzer 2004). oPregnant females as pain degree change might be due to hormones. (Ibhawoh, 2015). Teeth: -That can't be isolated with rubber dam. (to avoid accidental ingestion of any endodontic material or instrument, Bondarde 2015). -With previous root canal treatment. -With mobility. -With periodontal probing more than 4 mm. (as it will be an endo-perio case). 18 Year(s) 55 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 02/02/2016 Ethics Committee of Scientific Research, Faculty of Oral and Dental Medicine, Cairo University.
Ethics Committee Address
Street address City Postal code Country
El-kasr El-Eini Hospital, El-Manial cairo 00202 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post-operative pain 4 hours 12 hours 24 hours 48 hours
Secondary Outcome endotoxin quantification Before mechanical preparation After mechanical preparation After intra-canal medication(after one week)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental Medicine, Cairo University El-Kasr El-Eini hospital, El-Manial Cairo 00202 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fatma El-Zahraa Osman El-Abbasy 32 A yehia ibrahim street, zamalek cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Salsabyl Ibrahim Cairo Egypt
Geraldine Mohamed cairo Egypt
Sarah Samir cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salsabyl Ibrahim salsa.root@yahoo.com 01001402034
City Postal code Country Position/Affiliation
cairo Egypt Proffessor in Endodontic department, Faculty of oral and dental medicine, cairo university
Role Name Email Phone Street address
Public Enquiries Sarah Samir sarahbeltagi@yahoo.com 01000703203
City Postal code Country Position/Affiliation
cairo Egypt assistant lecturer in endodontic department, faculty of oral and dental medicine, cairo university
Role Name Email Phone Street address
Scientific Enquiries Geraldine Mohamed geraldine.ahmed.7@hotmail.com 01226322227
City Postal code Country Position/Affiliation
cairo Egypt Assistant proffessor in endodontic department, faculty of oral and dental medicine, cairo university
REPORTING
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