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.: PACTR202202848424858 Date of Approval: 22/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing the efficacy of two different anesthetic solutions in pain control during extraction of mandibular primary molars
Official scientific title Biological Evaluation of the efficacy of two different anesthetic solutions in pain control during extraction of mandibular second primary molars
Brief summary describing the background and objectives of the trial The current study will compare between alexadricaine 4% and mepevacaine 2% in pain control during extraction of mandibular primary molars in primary teeth, when administered by infiltration technique and the change that occurs in pulse rate before and after extraction in each group will be recorded.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial treatment using the least invasive anesthetic technique in dentistry for children
Anticipated trial start date 01/11/2021
Actual trial start date 10/11/2021
Anticipated date of last follow up 11/01/2022
Actual Last follow-up date 18/01/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Alexadricaine 1.8 ml of the anesthetic solution injected once by infiltration technique injection of the anesthesia is performed over 30 seconds it is an Articaine type of local anesthesia 25
Control Group Mepecaine 1.8 ml of the anesthetic solution injected once using infiltration technique injection of the local anesthesia over 30 seconds it is Mepivacaine type of local anesthesia 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Co-operative children their age range 6-8years, with behavior rating scale 3 or 4 according to the Frankle behavior scale. • Children with non restorable mandibular second primary molar indicated for extraction due to root caries. • Children attending their first dental visit. • Both sexes were included. • Children with an acute dental abscess. • Children with marked root or bone resorption. • Children with a history of bleeding disorders or hypersensitivity. • Patients who had taken analgesics in the 12-hours preceding the injection. • Children whose parents refuse to sign the informed consent. Child: 6 Year-12 Year 6 Year(s) 8 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 28/10/2021 Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
bohoth st Cairo 12211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in the pulse rate before and after extraction in each group Before extraction and After extraction
Secondary Outcome Pain assessment using Wong Baker Facial Pain Scale Immediately after extraction
Secondary Outcome Pain assessment using Sound Eye Motor scale During extraction
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Research Centre Elbohoos street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rasha F. Sharaf pyramids street Cairo 12211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rasha Sharaf Haram st Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rasha Sharaf rasha_sharaf@hotmail.com 00201005022546 haram st
City Postal code Country Position/Affiliation
Cairo Egypt Researcher at the National Research Centre
Role Name Email Phone Street address
Scientific Enquiries Nihal Kabel Nihalkabel@live.com 00101001918141 Zayed st
City Postal code Country Position/Affiliation
Cairo Egypt Ass. Prof of Pediatric Dentistry
Role Name Email Phone Street address
Public Enquiries Rasha Sharaf rasha_sharaf@hotmail.com 00201005022435 haram st
City Postal code Country Position/Affiliation
Cairo Egypt Researcher at the National Research Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the data will be available including the study protocol, data statistical analysis and results for anyone interested in the study after publication Informed Consent Form,Statistical Analysis Plan,Study Protocol The study time frame is 2 months to be able to perform the clinical procedures to all the participants the data will be available to anyone interested in the study after publication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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