| CTRI Number |
CTRI/2024/10/075310 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Screening Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of light therapy on pain and anxiety levels in local anesthesia injection technique |
|
Scientific Title of Study
|
Evaluation of low level laser therapy on pain perception and anxiety levels in conventional local anesthesia injection. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Lalasa |
| Designation |
Post graduate |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India
Guntur ANDHRA PRADESH 522509 India |
| Phone |
09963720228 |
| Fax |
|
| Email |
lalasagaddam65@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anumala Deepa |
| Designation |
Professor |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India
Guntur ANDHRA PRADESH 522509 India |
| Phone |
09618501146 |
| Fax |
|
| Email |
anumala.deepas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr G Lalasa |
| Designation |
Post graduate |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India
Guntur ANDHRA PRADESH 522509 India |
| Phone |
09963720228 |
| Fax |
|
| Email |
lalasagaddam65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh, India,
PINCODE-522509 |
|
|
Primary Sponsor
|
| Name |
G.lalasa |
| Address |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra
Pradesh,India, PIN CODE-522509 |
| 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 GLALASA |
Sibar Institute Of Dental Sciences |
Department of Periodontology, Second floor, Room number-8, Sibar
Institute of Dental Sciences, Takkellapadu, Guntur, Andhra Pradesh,
PIN CODE-522509 India
Guntur
ANDHRA PRADESH
522509
India Guntur ANDHRA PRADESH |
09963720228
lalasagaddam65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIBAR INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lignocaine |
2ml of lignocaine is loaded into syringe and injected |
| Intervention |
low level laser light |
Low level laser therapy (LLLT) recently named as photobiomodulation therapy (PBMT) is a form of non-thermal light therapy with several clinical outcomes in favor of pain and inflammation reduction, immunomodulation, and tissue regeneration. LLLT is a monochromatic and coherent light of single wavelength, which works on the principle of photobiostimulation of the cells. This effect causes modifications in the function of cells and tissues. about 656 nm wavelength, with 5/J of energy for 25 sec at a 1mm distance is passed.The low level laser light is passed once for about 25 sec before local anesthesia administration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are apparently healthy.
2. Patients requiring bilateral periodontal therapy
|
|
| ExclusionCriteria |
| Details |
1. Patients under medication.
2. Pregnant or lactating females
3. Drug and alcohol abuse.
4. Tobacco users
5. Patients who are allergic to local amide anesthetics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess HAM-A, VAS and WBFR in both groups. |
baseline, after application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hamilton anxiety ating scale, visual analogue scale, wong becker faces rating rate |
baseline, after application |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
09/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal diseases are a
range inflammatory diseases caused due to bacterial buildup. If left untreated
these diseases can lead to the deterioration of tooth supporting structures and
eventually tooth loss. Depending upon the severity of the disease periodontal
treatment can be restricted to nonsurgical or could involve surgical
intervention. Both treatments could be an unpleasant experience for the
patients and hampers the patient’s day to day activity. Several
strategies can be used to reduce pain perception in dental anesthetic
injection, including the use of a higher gauze needle, slow speed of anesthetic
injection, optimization of the pH at the injection site, and selection of a proper
type of anesthetic agent. Low level
laser therapy (LLLT) recently named as photobiomodulation therapy (PBMT) is a
form of non-thermal light therapy with several clinical outcomes in favor of
pain and inflammation reduction, immunomodulation, and tissue regeneration.
LLLT is a monochromatic and coherent light of single wavelength, which works on
the principle of photobiostimulation of the cells. This effect causes
modifications in the function of cells and tissues. Following
the absorption of light by the cellular photo-acceptors, cell reaction and
proliferation and protein synthesis, vasodilatation and activation of several
signaling pathways takes place. The optimal laser wavelengths for
the therapeutic effects are usually in the red to near infrared spectrum (600
to 1000nm) with an energy density up to 10J/cm2 on the target sites, which has
been confirmed to stimulate biological process.The use
of LLLT to decrease the level of pain perception during injection.
The use of LLLT to reduce pain of injection of the local anesthetic agent in
the oral cavity is not yet well established. Therefore the purpose of this
study was to evaluate the effect of LLLT before needle insertion in an adult
population in reducing pain of injection of the local anesthetic agent. Subjects will be assessed based on inclusion and exclusion criteria. Subjects with maxillary bilateral surgical intervention in a split-mouth
design will be performed. Prior to injection low level
laser therapy (LLLT) application will be performed in non contact pulse mode at
the selected site in Group I, The irradiation was done by using a hand piece
0.5cm2 spot size at 650nm wavelength, with 5/J of energy for 25 sec at a1mm distance. In the Group II, laser
irradiation will be done for 25 sec similar to the Group I in off mode. For
safety, laser irradiation will be carried out with use of protection eyewear. Later
2% lidocaine plus 1: 100000 epinephrine was injected with conventional needle
at a speed of 1ml/min by operator in both the groups.
|