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.: PACTR201605001482394 Date of Approval: 22/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of postoperative pain and quantification of endotoxins in infected root canals
Official scientific title Evaluation of postoperative pain and quantification of endotoxins in infected root canals using antibiotic paste versus calcium hydroxide as intra-canal medication
Brief summary describing the background and objectives of the trial The presence of microorganisms as a result of failure to properly disinfect the canal is the most common cause of pain. Thus, endodontic therapy is primarily focused on maximum elimination of these bacteria. Antibacterial intra-canal dressing is advocated to eliminate remaining bacteria after chemicomechanical preparation. Antibiotic paste, is a mixture of metronidazole and ciprofloxacin, which is used as intra-canal medication for disinfection of necrotic teeth. Antibiotic paste has been reported to be effective at reducing bacterial numbers in the root canal systems of infected teeth. When most commonly used medicaments fail in eliminating the symptoms, then antibiotic paste could be used clinically in the treatment of teeth with large periradicular lesions. Objective of the trial is to assess the ability of antibiotic paste versus calcium hydroxide used as intra-canal medication in reducing pain and level of endotoxins in necrotic single rooted premolar teeth with apical periodontitis. Each patient will be given pain scale chart in order to record his /her pain level preoperatively,6,12,24 and 48 hours postoperatively. Endotoxin sampling will be taken after access, after preparation and after intracanal medication.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/11/2015
Actual trial start date 01/02/2016
Anticipated date of last follow up 01/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 36
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 A random sequence will be generated by computer software. eight folded numbered papers will be packed in opaque sealed envelopes to be dragged by the patients. 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 medication 18
Control Group calcium hydroxide 7 days intracanal medication 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18-55 years old. Males or Females. Maxillary or mandibular single rooted premolar teeth. Non-Vital response of pulp tissue. Slight widening in lamina dura. Tenderness to percussion. Pregnant females: Pain degree change may be due to hormonal change, and some medications are contra indicated. Patients who had received antibiotic treatment during the last 3 months. Patients having more than one tooth require root canal treatment. Teeth with periodontal probing depth > 4mm. Teeth that could not be isolated with a rubber dam. Fluctuant facial swelling (acute abscess) Previous root canal treatment. 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
Yes 30/09/2015 Research ethics committee, Cairo university
Ethics Committee Address
Street address City Postal code Country
12 Saray Elmanial Cairo - Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative Pain preoperatively 6 hours postoperatively 12 hours postoperatively 24 hours postoperatively 48 hours postoperatively
Secondary Outcome quantification of endotoxins after access cavity preparation, after mechanical preparation, after 7 days of intracanal medication
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Endodontic clinic at the faculty of oral and dental medicine, Cairo University 12 Saray Elmanial street Cairo - Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self-funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and dental medicine, cairo university 12 saray elmanial cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Geraldine Ahmed west somed 6th of october city - Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Abouelenien sarah.abouelenien@dentistry.cu.edu.eg +201000703203 Mena garden city
City Postal code Country Position/Affiliation
6th october city - Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Geraldine Ahmed geraldine.ahmed@hotmail.com +201226322227 west somed
City Postal code Country Position/Affiliation
6th of october city - Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Salsabyl Ibrahim Salsa.root@yahoo.com +201001402035 Masr elgedida
City Postal code Country Position/Affiliation
Cairo - Egypt Professor
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information