| CTRI Number |
CTRI/2018/01/011639 [Registered on: 31/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
omparative evaluation of 4% articaine with 2% lignocaine for extractions of deciduous maxillary teeth. |
|
Scientific Title of Study
|
Comparative evaluation of anesthetic efficacy of buccal infiltration anesthesia using 4% articaine with buccal and palatal infiltration using 2% lignocaine for extractions of deciduous maxillary teeth. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashree Jankar |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pedodontics and Preventive Dentistry, MGVs KBH Dental College and Hospital, Nashik |
| Address |
Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik
Nashik MAHARASHTRA 422003 India |
| Phone |
|
| Fax |
|
| Email |
jayashreejankar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhushan Pustake |
| Designation |
Professor and Guide |
| Affiliation |
Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik |
| Address |
Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik
Nashik MAHARASHTRA 422003 India |
| Phone |
|
| Fax |
|
| Email |
bhushanpustake@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jayashree Jankar |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik |
| Address |
Department of Pedodontics and Preventive Dentistry,MGVs KBH Dental College and Hospital, Nashik
Nashik MAHARASHTRA 422003 India |
| Phone |
|
| Fax |
|
| Email |
jayashreejankar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Jayashree Jankar |
| Address |
D-703, Sumer Castle, Castle Mill Naka, LBS Road, Thane-West |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayashree Jankar |
MGVs KBH Dental College and Hospital, Nashik. |
Room no-605,Department of Pedodontics and Preventive Dentistry. Nashik MAHARASHTRA |
9820656654
jayashreejankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGVs KBH Dental College and Hospital, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
indicated for bilateral maxillary deciduous teeth extraction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine Hydrochloride |
2% Lignocaine Hydrochloride with 1:80,000 Epinephrine |
| Intervention |
4% Articaine Hydrochloride |
4% Articaine Hydrochloride with 1:100,000 Epinephrine |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 5-10 years requiring administration of local anesthetic agent for bilateral extractions of maxillary deciduous teeth, Children falling in the Frankel behaviour rating scale of positive and definitely positive, No history of intra-oral injections, Only children whose parental consent is obtained before procedure.
|
|
| ExclusionCriteria |
| Details |
Allergy to sulfites or amide type of local anesthetics, Severe systemic disease contraindicating tooth extraction, Evidence of soft tissue infection near the proposed injection site, Inability to give informed consent, Taking any medications that might alter pain perception or anesthetic assessment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of anesthesia |
At the day of intervention (0 day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effects |
At the day of intervention (0 day) |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2016 |
| Date of Study Completion (India) |
14/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain
control in dentistry is an important part in reducing the fear and anxiety
associated with dental procedures especially in children. Pain on palatal injection is a very commonly experienced symptom
in dentistry and as such is a major concern to dentist. A number of techniques may be
used to reduce the discomfort of intra-oral injections, the application of
topical anaesthetic being a well-known and frequently used option. However, it is effective only on
surface tissues (2–3 mm) and tissues deep to the area of application are poorly
anesthetized. Surface anaesthesia does allow
for atraumatic needle penetration, but because of the density of the palatal
soft tissues and their firm adherence to the underlying bone, palatal injection
is still painful. Local anaesthetics form the backbone of pain
control in dentistry and there has been substantial research for safe and
effective local anaesthetic agent. 2% lignocaine is the “gold standard†to which
all new local anaesthetics are compared and considered most efficacious anaesthetic
agent for use in pediatric and adult patients. Articaine is unique amide local anaesthetics
that consist of ester group and thiophene ring which makes it more potent and
more lipid soluble and accounts for faster diffusion properties within tissues
and bone. Due to this property of diffusion, profound anaesthesia can be
achieved on palatal side with buccal infiltration. It has been claimed
that articaine is able to diffuse through soft and hard tissues more reliably
than other local anaesthetics and that maxillary buccal infiltration of
articaine provides palatal soft tissue anaesthesia, obviating the need for a
palatal injection which in many hands, is traumatic. Hence, the present study was conducted to
evaluate clinically the anesthetic efficacy of only buccal infiltration
anesthesia using 4% articaine with buccal plus palatal infiltration using 2%
lignocaine for extractions of deciduous maxillary teeth. |