Comparing anesthetic efficacy of 4% Articaine and 2% Lidocaine as buccal infiltration in mandibular ramus block harvesting for bone augmentation in implant patients requirin bone augmentation
The purpose of this study is to investigate the possibility of anesthetizing the target tissues during bone removal surgery from the ramus of the mandible, using the buccal infiltration technique instead of block injection.
Design
Controlled, parallel-group, double-blind and randomized phase 3 clinical trial on 20 patients. The rand function of Excel software is used for randomization.
Settings and conduct
The study is carried out in the surgical department of Qazvin Dental Faculty. After the examination and diagnosis of the need for bone grafting before the implant, the patients enter the study voluntarily. Before the surgery, 2% chlorhexidine mouthwash is swirled in the mouth for 30 seconds and then, one of the two types of anesthesia according to the sealed envelope that has been prepared in advance, is given to the surgeon to inject. Patients and researchers are not aware of the type of anesthesia. The surgeon is one of the researchers and isn't aware of the type of anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18-65 years old
Systemically healthy people
capable of filling out questionnaires
Exclusion criteria:
Patient withdrawal/reluctance to participate in the study
Intervention groups
The intervention group includes patients who are candidates for graft surgery, and 2% lidocaine will be used for anesthesia.
The comparison group includes patients who are candidates for graft surgery, and 4% articaine will be used for anesthesia.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230210057378N1
Registration date:2023-03-18, 1401/12/27
Registration timing:registered_while_recruiting
Last update:2023-03-18, 1401/12/27
Update count:0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Amir Hasanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 4815
Email address
a.hasanpour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing anesthetic efficacy of 4% Articaine and 2% Lidocaine as buccal infiltration in mandibular ramus block harvesting for bone augmentation in implant patients requirin bone augmentation
Public title
Comparing anesthetic efficacy of 4% Articaine and 2% Lidocaine in mandibular bone grafts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between 18 and 65 years old
Systemically healthy people
Having the ability to fill out questionnaires
People with bone defects in the edentulous area and candidate for bone graft
People who need implants in the upper jaw or the opposite side of the bone removal area in the lower jaw (contralateral)
Exclusion criteria:
Presence of an abscess or any pathological lesion at the injection site
History of diabetes, cardiovascular diseases, hypertension and kidney diseases
History of allergy to Lidocaine or Articaine local anesthetics
Consumption of alcohol or any pain reliever
Mentally unable to give informed consent
pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be divided into two groups of 4% Artecaine and 2% Lidocaine in the form of blocked randomization. Blocking and sequencing of samples will be done with random allocation software. In order to conceal the random allocation process, the names of the groups are placed in envelopes, numbered on these envelopes from 1 to ... and arranged in a box in order. The researcher who performs the random allocation will not be aware of the contents of the envelopes. The contents of the envelopes indicate the study groups (intervention or placebo) and after ensuring that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and according to the contents of the envelope in are included in one of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be done in a double-blind manner. In this way, the examined patients and the observer will be unaware of the type of intervention. Patients will be given a full explanation of the intervention to be performed with details, but the type of local anesthetic used will remain hidden from them. The type of local anesthetic is determined according to the sealed letter that has been prepared in advance, but the therapist, who is also a researcher, is unaware of the type of local anesthetic and will only know whether it is group one or two. Grouping is done randomly as described above. Cartridges containing anesthetic solutions, with the type of solution and its specifications written on it, are covered with a opaque cover so that only their expiration date is known. On the opaque cover, the anesthetic group (one or two) is written.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.QUMS.REC.1401.360
Health conditions studied
1
Description of health condition studied
Severe bone defects in the jaws
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of people who have pain during surgery
Timepoint
The presence of pain during surgery and throughout its duration
Method of measurement
Asking the patient about the presence or absence of pain
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Lidocaine local anesthetic 2% - Persocaine-E (lidocaine) 2% manufactured by Daroopakhsh company - each cartridge contains 1.8 ml anesthetic solution - 12.5 micrograms epinephrine - 38 mg lidocaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration.
Category
Treatment - Drugs
2
Description
Intervention group: Articaine local anesthetic 4%- Artheek 4% manufactured by New Stetic Company - each cartridge contains 1.8 ml anesthetic solution - 18 micrograms of epinephrine - 72 mg of articaine hydrochloride. For each patient, an anesthetic cartridge is injected in the posterior buccal of the mandible in the form of infiltration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin university of medical sciences
Full name of responsible person
Amir Hasanpour
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 3061
Email
ahasanpour23@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Hasanpour
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 3061
Email
ahasanpour23@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?