Comprison of anesthetic efficacy of Buccal Infilteration versus Inferior Alveolar Nerve block for Pulpotomy in Mandibular Second Primary Molars in sedated patients
Comprison of anesthetic efficacy of Buccal Infilteration versus Inferior Alveolar Nerve block for Pulpotomy in Mandibular Second Primary Molars in sedated patients
Design
All treatment steps were performed by a pediatric dentist .Type of injection was performed randomly with a coin on each side of the jaw.
Settings and conduct
Shahid Beheshti Faculty of Dentistry Fellowship Department
Participants/Inclusion and exclusion criteria
inclusion criteria :3-6 year-old non-cooperative children (negative or completely negative based on Frankel scale)
A child with ASA Class I systemic status with 2 mandibular decayed second molar teeth.
The patient needs to undergo at least 2 similar dental treatment sessions
Exclusion criteria: Radiographic signs such as internal and external pathological resorption, radiolucency of the periapical area or physiological resorption of more than 1/3 of the root length.
Intervention groups
First, oral midazolam is administered . After 30 minutes, sedation with ketamine and propofol drugs will be started in a titrated manner.
In each treatment session, one side of the jaw will be anesthetized randomly with one of the anesthetic techniques with 1/2 carpool of 2% lidocaine or buccal infiltration with 1/3 carpool of articaine 4%. The dental treatment performed will be the pulpotomy of the second molar tooth.After removing the caries and inflamed pulp of the coronal area, formocresol will be used to fix the pulp of the orifice area.
After placing Zonalin in the pulp chamber, the tooth will be restored with a stainless steel veneer and glass ionomer cement.
The time to evaluate the behavioral and physiological parameters will be immediately after receiving the sedative (T0), during anesthesia injection (T1), during pulp exposure (T2) and after transferring the child to the recovery room (T3).
Main outcome variables
The effectiveness of both techniques is similar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190313043046N2
Registration date:2023-06-13, 1402/03/23
Registration timing:registered_while_recruiting
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Taraneh Faghihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7571
Email address
trnfaghihi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-11, 1402/03/21
Expected recruitment end date
2023-07-12, 1402/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprison of anesthetic efficacy of Buccal Infilteration versus Inferior Alveolar Nerve block for Pulpotomy in Mandibular Second Primary Molars in sedated patients
Public title
Comprison of anesthetic efficacy of Buccal Infilteration versus Inferior Alveolar Nerve block for Pulpotomy in Mandibular Second Primary Molars in sedated patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3-6 year-old non-cooperative children (negative or completely negative based on Frankel scale)
A child with ASA Class I systemic status has 2 mandibular decayed second molar teeth on the right and left sides, without clinical or radiographic symptoms, with the possibility of pulpotomy after caries removal.
The patient needs to undergo at least 2 similar dental treatment sessions with local anesthesia
Exclusion criteria:
History of any clinical symptoms such as spontaneous pain, soft tissue swelling, fistula, mobility of primary second molar teeth or abnormal bleeding during access cavity preparation.
Radiographic symptoms such as internal and external pathological resorption, radiolucency of the periapical area or furcation or physiological resorption of more than 1/3 of the root length.
History of cold in the last 14 days
Any adverse drug reaction to local anesthetics or sedatives
Age
From 3 years old to 6 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Sequentially numbered, opaque, sealed envelopes were used in this study for random allocation which were kept by the Nurse of fellowship department
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and analyzer are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Comprison of anesthetic efficacy of Buccal Infilteration versus Inferior Alveolar Nerve block
Timepoint
Comparison of the effectiveness of infiltration and block anesthesia technique in two treatment sessions
Method of measurement
according to Nonverbal pain scale revised
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Randomly a second primary molar on one side of the jaw is anesthetized by buccal infiltration technique with Articaine.
Category
Treatment - Other
2
Description
Intervention group: Randomly, the second molar tooth on the opposite side of the jaw is anesthetized using the lower alveolar nerve block method with Lidocaine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric dentistry fellowship clinic of Shahid Beheshti Dental School