| CTRI Number |
CTRI/2023/05/053284 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing the effect of peppermint oil and lignocaine spray application before giving local injection |
|
Scientific Title of Study
|
Comparative Evaluation of Topical Application of Peppermint oil and Lignocaine spray prior to Local Anesthesia Administration: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Petluru Harika |
| Designation |
PG Student |
| Affiliation |
Narayana dental college and hospital |
| Address |
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9154642062 |
| Fax |
|
| Email |
harikahary95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S V S G Nirmala |
| Designation |
Assistant professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9440206976 |
| Fax |
|
| Email |
nimskrishna2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Narayana Dental College and Hospital
Department of Paediatric and Preventive dentistry
Division-dental block
Room no-7
Chintareddy Palem
Nellore
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Petluru Harika |
| Address |
Narayana dental college and hospital
Chintareddypalem
Nellore
Andhrapradesh |
| Type of Sponsor |
Other [Self Sponser] |
|
|
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 Petluru Harika |
Narayana dental college and hospital |
Division7
Department of Paediatric and Preventive dentistry
Andhra Pradesh
Nellore
ANDHRA PRADESH |
9154642062
harikahary95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Narayana dental college and hospital |
Approved |
| Institutional Ethical Committee Narayana dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental anxiety and Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peppermint Oil |
Peppermint oil has a variety of therapeutic properties such as analgesic, anesthetic and antiseptic etc. When used in mouthwashes, toothpastes, and topical applications. Fresh cooling effect of Menthol can produce anesthetic property to peppermint oil. thus application of one minute peppermint oil can help to reduce needle prick pain sensation. Application time 1 minute. |
| Comparator Agent |
Topical Lignocaine Spray |
Lignocaine spray reduces needle prick pain sensation. Applied onto the surface of injection site for a minute. Effective only up to very few millimeters(2-3mm) on to the surface of mucosa applied. Application time 1 minute |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Children aged 8-13 years who attending dental hospital
2.Children indicated for dental procedures under local anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Children with Acute infections or Systemic diseases
2. Children with special care needs
3. Children with dental emergency which include trauma, acute pulpitis, dental abscess, cysts, pericoronitis etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of topical application of peppermint oil with lignocaine spray in reducing dental anxiety among children |
Baseline
During administration of LA
After administration of LA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of topical application of peppermint oil with lignocaine spray in reducing pain among children |
During administration of LA
After administration of LA |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2023 |
| 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="0"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Among the various methods used to alleviate pain
caused by needle penetration, Topical anesthetics stand apart as the gold
standard method. PEPPERMINT (Mentha piperita) is a popular herb that
can be used in numerous forms (ie, oil, leaf, leaf extract, and leaf water). It is a colourless or
pale-yellow liquid with a fresh sharp menthol odour, when
applied to the skin, it causes a cooling sensation. The anesthetic property of Peppermint oil remains
unexplored, even though they have been widely used for various ailments.
Peppermint oil has a variety of therapeutic properties such as analgesic,
anesthetic and antiseptic etc. When used in mouthwashes, toothpastes, and
topical applications.
AIM: To compare and evaluate the pain perception following topical
application of a peppermint oil and lignocaine spray prior to intra oral
injection in children aged 8-13 years.
OBJECTIVES:
·
To evaluate the topical
anesthetic effect of peppermint oil during intra oral injection in children
·
To evaluate the topical
anesthetic effect of lignocaine spray during intra oral injection in children
·
To compare the effectiveness of
topical anesthetic effects of peppermint oil and Lignocaine spray during intra oral
injection in children
|