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.: PACTR201511001275414 Date of Approval: 23/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title POSTOPERATIVE PAIN, ANTIBACTERIAL EFFECT AND HEALING OF CHRONIC PERIAPICAL LESIONS TREATED WITH DIODE LASER VERSUS ENDODONTIC SURGERY: A Randomized Co
Official scientific title POSTOPERATIVE PAIN, ANTIBACTERIAL EFFECT AND HEALING OF CHRONIC PERIAPICAL LESIONS TREATED WITH DIODE LASER VERSUS ENDODONTIC SURGERY: A Randomized Control Trial
Brief summary describing the background and objectives of the trial The aim of this study is to investigate the use of diode laser inside the root canals of necrotic teeth with chronic periapical lesion and its antibacterial effect, healing and its ability to decrease the postoperative pain without the need of endodontic surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied endodontic,Infections and Infestations,Surgery
Sub-Disease(s) or condition(s) being studied endodontic
Purpose of the trial Treatment: Other
Anticipated trial start date 12/10/2015
Actual trial start date
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Parallel: different groups receive different interventions at same time during study Randomised A random sequence will be generated by computer software sealed opaque envelope Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group diode laser application inside the root canal 4 irradiation of 5 seconds each with 5 rest period between each irradiation 2 times with one week interval 980 nm diode laser coupled with 200 um fiber optic 25
Control Group Endodontic surgery No laser application N/A N/A 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults Medically free patients Upper anterior teeth with necrotic pulp and chronic periapical lesion with Evidence of radiological periapical lesion (<5mm) Healthy dental and periodontal status Teeth with open apex Pregnant or nursing female patients Acute pain at time of the intervention 18 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 Ethics Committee of Scientific Research, faculty of oral and dental medicine, Cairo University.
Ethics Committee Address
Street address City Postal code Country
11 el Saraya st. El manial cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain 6 hours 12 hours 24 hours 48 hours 7 days
Secondary Outcome healing 3 months 6 months
Secondary Outcome Antibacterial effect After access After mechanical preparation After laser application for the experimental group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of oral and dental medicine 11 el-Saraya st. El manial cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 33 green heights compound, 6 october Giza 12311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of oral and dental medicine 11 el Saraya st. El manial cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
maged negm 3 Mohamed kamel Morsy, mohandessine cairo 12311 Egypt
Alaa diab 11 el Saraya st. El manial Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dina morsy dina.amorsy@dentistry.cu.edu.eg +201223980157 33 green heights, 6 october
City Postal code Country Position/Affiliation
cairo 12311 Egypt assistant lecturer in endodontic department, faculty of oral and dental medicine. Cairo university
Role Name Email Phone Street address
Public Enquiries Maged Negm Maged.negm@dentistry.cu.edu.eg 01006162637 3 Mohamed kamel Morsy st., mohandessine
City Postal code Country Position/Affiliation
Giza 12311 Egypt Professor in department of endodontic, faculty of oral and dental medicine, Cairo university
Role Name Email Phone Street address
Scientific Enquiries Alaa Diab Alaa.diab@dentistry.cu.edu.eg 01223417025 11el Saraya st., al manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Professor of endodontic, faculty of oral and dental medicine, Cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information