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.: PACTR201403000667409 Date of Approval: 06/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Incidence of Postoperative Pain and intra canal bacterial reduction Following Multiple visit Root Canal Treatment of Non Vital Teeth with Different In
Official scientific title Incidence of Postoperative Pain and intra canal bacterial reduction Following Multiple visit Root Canal Treatment of Non Vital Teeth with Different Intracanal Medicaments
Brief summary describing the background and objectives of the trial A flare-up following root canal appointment is upsetting to both patient and dentist. Flare-ups are more likely to occur in necrotic cases than in vital cases.Multiple-visit root canal treatment with medicament between root canal preparation and obturation is well-accepted as a safe and common therapy. The use of intracanal medicament has been widely accepted to eliminate residual bacteria within root canal system, reduce periapical inflammation and pain.Root canal medicament can be classified according to their chemical basis into phenolic compounds, aldehyde, halides, calcium hydroxide and antibiotic. Antibiotics can be used as an adjunct to endodontic treatment in a number of ways locally (intracanal medicament), systemically and prophylactically. local application of antibiotics may be a more effective mode for delivering antibiotics .The infection of the root canal system is considered to be a polymicrobial infection, consisting of both aerobic and anaerobic bacterial. Because of the complexity of the root canal infection, it is unlikely that any single antibiotic could result in effective sterilization of the canal. More likely a combination would be needed to address the diverse flora encountered. A combination of antibiotics would also decrease the likelihood of the development of resistant bacterial strains.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied non vital permanent teeth,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/09/2014
Actual trial start date 05/10/2014
Anticipated date of last follow up 06/12/2015
Actual Last follow-up date 31/12/2015
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
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 computer generated randomization Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised computer generated randomization 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 antibiotic paste 7 days intracanal medicament 24
Control Group calcium hydroxide 7 days intracanal medicament 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Medically free patients. 2- Permanent teeth with non vital plup. 3- Two visit root canal treatment using calcium hydroxide or antibiotic paste as intracanal medicament. 4- Clinical study. 5- Initial root canal treatment. 6- For bacterial sampling should be taken during the course of the treatment, before canal preparation (s1), after canal preparation (s2) and after canal medication (s3). 1- Primary teeth. 2- Permanent teeth with immature apex. 3- Single visit root canal treatment. 4- Vital cases. 5- Retreatment cases. 6- In vitro study. 7- Two visit root canal treatment not using calcium hydroxide or antibiotic paste as intracanal medicament. 18 Year(s) 50 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 ethics committee at national research center
Ethics Committee Address
Street address City Postal code Country
dokki giza 03 Egypt
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 10/10/2013 ethics committee at faculty of oral and dental medicine cairo university
Ethics Committee Address
Street address City Postal code Country
El manial cairo Egypt
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 10/10/2013 ethics committee at faculty of oral and dental medicine cairo university
Ethics Committee Address
Street address City Postal code Country
El manial cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain every 24 hours for 72 days
Secondary Outcome intra canal bacterial reduction preoperative sample, post instrumentation sample, post medication sample
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic of endodontic department- cairo university El manial cairo 02 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding Helipoplice cairo 02 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif el shershaby 22 ebn basam heliopolice cairo 11351 Egypt Funding Agency
Primary Sponsor sherif el shershaby 22 ebn basam heliopolice cairo 11351 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif el shershaby 22 ebn basam heliopolice cairo 11351 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif El Shershaby sherifelshershaby@gmail.com 01005268663 22 Ebn bassam Heliopolice
City Postal code Country Position/Affiliation
cairo 11351 Egypt
Role Name Email Phone Street address
Public Enquiries Sherif El Shershaby sherifelshershaby@gmail.com 01005268663 22 Ebn bassam Heliopolice
City Postal code Country Position/Affiliation
cairo 11351 Egypt
Role Name Email Phone Street address
Scientific Enquiries Sherif El Shershaby sherifelshershaby@gmail.com 01005268663 22 Ebn bassam Heliopolice
City Postal code Country Position/Affiliation
cairo 11351 Egypt
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