| CTRI Number |
CTRI/2019/12/022334 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of one injection during removal of tooth/teeth of upper jaw |
|
Scientific Title of Study
|
Effect of buccal infiltration injections of 4% Articaine hydrochloride on palatal tissue in maxillary teeth/tooth extraction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monalisa |
| Designation |
MDS Oral & maxillofacial surgery 1st year |
| Affiliation |
School of dental sciences,Sharda University |
| Address |
B8,604,Gardenia Glory,Sector 46,Noida
Knowledge Park III, Ruhallapur, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8867253243 |
| Fax |
|
| Email |
drmonalisa93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan M Patil |
| Designation |
Professor and HOD, Department of Oral & maxillofacial surgery |
| Affiliation |
School of dental sciences,Sharda University |
| Address |
School of dental sciences,Sharda University, knowledge park,greater noida
Knowledge Park III, Ruhallapur, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9999970260 |
| Fax |
|
| Email |
pavan.patil@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monalisa |
| Designation |
MDS Oral & maxillofacial surgery 1st year |
| Affiliation |
School of dental sciences,Sharda University |
| Address |
B8,604,Gardenia Glory,Sector 46,Noida
Knowledge Park III, Ruhallapur, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
8867253243 |
| Fax |
|
| Email |
drmonalisa93@gmail.com |
|
|
Source of Monetary or Material Support
|
| school of dental sciences,sharda university |
|
|
Primary Sponsor
|
| Name |
Dr Monalisa |
| Address |
B8,604,Gardenia Glory,sector 46,Noida |
| 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 Monalisa |
school of dental sciences,sharda university |
Department of oral and maxillofacial surgery, Room no 4
Gautam Buddha Nagar
UTTAR PRADESH |
8867253243
drmonalisa93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Sharda University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Lignocaine Hydrochloride with 1:80000 adrenaline |
1.8 ml will be injected as buccal infiltration and a greater Palatine nerve block if needed |
| Intervention |
4% Articaine Hydrochloride with 1:100000 adrenaline |
1.8 ml will be injected as buccal infiltration and a greater Palatine nerve block if needed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group- above 18 years
2. Physical status - ASA I and ASA II
3. Maxillary posterior teeth without mobility or associated pathology
|
|
| ExclusionCriteria |
| Details |
1. Immunocompromised patients
2. Physical status ASA III and above
3. History of allergy to local anaesthetics
4. Withdrawn consent
5. Pregnant and Lactating Women
6. Active Periodontitis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Injection pain
2.Procedure pain
3.Frequecy of requirement of palatal injection |
10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of analgesics used
2. Duration of anaesthesia
|
1.1 week
2.3 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain associated with administration of injectable local anaesthesia has been subject of research from the time of advent of local anaesthetic agents. Among the different injection techniques used, palatal anaesthesia is the most painful, and from a long time research has been directed at reducing the pain associated with intra oral palatal injections. Different methods such as topical anesthetic application, topical cooling of palate, computerized injection systems, pressure administration, Eutectic mixture of local anaesthesia (EMLA) and Transcutaneous electronic nerve stimulation have been tried but still are in the process of getting universal acceptance. The reason for the pain is attributable to adherence of palatal mucoperiosteum to the bone and lack of a subcutaneous tissue layer which leaves minimal space for deposition of the local anesthetic solution. Recentreports have suggested that removal of a maxillary tooth was possible without use of palatal anaesthesia with Articaine Hydrochloride 4% as a local anesthetic agent. However, other researchers have refuted these claims. It still remains to be established whether Articaine alone is effective for use in maxilla during removal of maxillary teeth without any palatal injection. The scope of current research is to compare and examine the effectiveness, safety and side effects of Lignocaine Hydrochloride 2% and Articaine Hydrochloride 4% in the extraction of maxillary posterior teeth with specific regard to avoidance of a palatal injection to establish palatal anesthesia. The pharmacologic properties of Articaine, which is capable of diffusing greater distances than other local anesthetics, coupled with the uniformly thin, cancellous maxillary bone, provide a plausible explanation for the success of palatal anesthesia achieved through buccal infiltration of Articaine, obviating the need for a palatal injection. |