| CTRI Number |
CTRI/2017/02/007922 [Registered on: 20/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluating the effect of conventional local anaesthesia anaesthesia (lignocaine), warming it and adding a buffer on the success of a nerve block in lower primary posterior teeth |
|
Scientific Title of Study
|
Comparative Evaluation Of Anaesthetic Efficacy Of warm, Buffered And Conventional 2% Lignocaine For The Success Of Inferior Alveolar Nerve Block In Mandibular Primary Molars- A Randomized Clinical Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reenu Sarah Kurien |
| Designation |
Post Graduate student (MDS) |
| Affiliation |
ITS Dental College, Hospital And Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre
Plot No. 47
Knowledge Park III
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9873825939 |
| Fax |
|
| Email |
kurienreenu7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Professor and Head, Department Of Pedodontics And Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital And Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre
Plot No. 47
Knowledge Park III
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi_leo@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Reenu Sarah Kurien |
| Designation |
Post Graduate student (MDS) |
| Affiliation |
ITS Dental College, Hospital And Research Centre |
| Address |
ITS Dental College, Hospital and Research Centre
Plot No. 47
Knowledge Park III
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9873825939 |
| Fax |
|
| Email |
kurienreenu7@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Hospital And Research Centre
Plot No. 47
Knowledge Park III
Greater Noida
Uttar Pradesh 201308 |
|
|
Primary Sponsor
|
| Name |
Reenu Sarah Kurien |
| Address |
ITS Dental College Hospital And Research Centre
Plot No. 47
Knowledge Park III
Greater Noida
Uttar Pradesh 201308 |
| 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 |
| Reenu Sarah Kurien |
I.T.S Dental College, Hospital And Research Centre |
Department Of Pedodontics and Preventive Dentistry
Room no. 8
Fourth Floor
ITS dental College, Hospital And Research Centre
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9873825939
kurienreenu7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
children aged 6-12 years, with bilateral vital pulp involvement in primary mandibular molars., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buffered, warmed lignocaine local anaesthesia |
2% buffered lignocaine, 2% warmed lignociane provided as Inferior Alveolar Nerve Block. |
| Comparator Agent |
Conventional lignocaine local anaesthesia |
2% conventional lignocaine provided as Inferior Alveolar Nerve Block |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.patients having deep dentinal caries extending through half the dentinal depth wrt 74, 75, 84, 85
2. patients complaining of mild to moderate pain.
3.teeth with vital pulp
4.children with frankl behaviour rating of 3 or 4
5.patients whose parents/guardians give consent
6.subjects should be free of systemic disease
7.the agreement to comply with study visits and procedures.
|
|
| ExclusionCriteria |
| Details |
1.patients who are physically or medically compromised/ systemic disease
2.patients with allergies to local anaesthetics, sulphites or sodium bicarbonate
3.patients on any medication
4.presence of abscess or sinus openings at the site of injection or at the tooth involved.
5.children with frankl behaviour rating of 1 or 2 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Anaesthetic efficacy
2.The patient’s pain reaction |
3-5 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain during administration of anaesthesia
2.Onset of anaesthesia
3.Pain while performing pulp therapy
4.Duration of anaesthesia |
3-5 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2015 |
| Date of Study Completion (India) |
Date Missing |
| 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
Modification(s)
|
Published in Journal Of Dental Research Dental Clinics Dental Prospects spring 2018, Vol 12, No.2
doi:10.15171/joddd.2018.016 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blinded, split mouth clinical trial, comparing the anaesthetic efficacy and patient’s pain reaction to warm lignocaine, buffered lignocaine and conventional 2% lignocaine during pulp therapy in primary mandibular molars. 50 patients were randomly divided into 2 groups and were given conventional lignocaine on one visit on one side and either buffered or warmed lignocaine on the other side during the next visit. The results showed that the pain on administration, mean onset of anaesthesia, pain during pulp therapy, the parameters of the SEM score and the duration of anaesthesia were all significantly lower for the buffered and warmed solutions compared to the conventional solution. However there was no significant difference on comparing the warmed and buffered groups with each other. Thus it can be concluded that modifying local anaesthesia by either buffering it or warming it can be beneficial in reducing the pain on injection and during pulp therapy, especially in children. |