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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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