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CTRI Number  CTRI/2024/06/069566 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study on the effect of two different concentration of pain reliever added to local anaesthesia agent in severe tooth pain condition. 
Scientific Title of Study   Comparative Evaluation of Peri-operative Analgesic Effect of Lidocaine Combined with Opioid Analgesic in Patients with Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis in Mandibular Molars – A Double Blind Randomized Controlled Clinical Trial. 
Trial Acronym  PAE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay Amirtharaj L 
Designation  Reader 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor SRM Dental College Bharathi Salai, Ramapuram.
Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9884111167  
Fax    
Email  vijaya1@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mary Nancy S 
Designation  Consultant Anesthesiologist 
Affiliation  SRM Prime Hospital 
Address  SRM Prime Hospital, Ramapuram, Chennai, Tamilnadu, India.

Kancheepuram
TAMIL NADU
600089
India 
Phone  9940208571  
Fax    
Email  drmarynancy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mahalaxmi S 
Designation  Professor and Head 
Affiliation  SRM Institute of Science and Technology 
Address  Department of Conservative Dentistry and Endodontics, Out patient department 2nd floor SRM Dental College Bharathi Salai, Ramapuram.
Chennai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax    
Email  mahalaxr@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Dental College Ramapuram, Chennai, Tamilnadu, India. 600089. 
 
Primary Sponsor  
Name  SRM Dental College 
Address  2nd Floor, Department of Conservative Dentistry and Endodontics, SRM Dental College, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu 600089.  
Type of Sponsor  Research institution and hospital 
 
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 Vijay Amirtharaj L  SRM Dental College  Department of Conservative Dentistry and Endodontics, Out Patient Department 2nd Floor, SRM Dental College, Bharathi Salai, Ramapuram, Chennai TAMIL NADU Chennai
Chennai
TAMIL NADU 
9884111167

vijaya1@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Institutional Ethical Committee, SRM Dental College, Ramapuram, Chennai-89.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lignocaine   1.5 ml of 2% lignocaine will be injected at the Coronoid notch and pterogomandibular raphae to locate the inferior alveolar nerve site. 
Intervention  Lignocaine and Buprenorphine  1.5 ml of freshly prepared 2% lignocaine with 75mcg and 150mcg of buprenorphine hydrochloride will be injected at the Coronoid notch and pterogomandibular raphae to locate the inferior alveolar nerve site. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  • ASA I & II
• Pain severity with HP-VAS (85-170) Moderate – Severe in mandibular molars. 
 
ExclusionCriteria 
Details  • ASA III
• Patient consumed any anti-inflammatory drugs 24 hrs before the day of reporting.
• Allergic to LA
• Pregnant & lactating women
• Patients under the influence of alcohol 24 hrs before the procedure.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To comparatively assess the perioperative analgesic efficacy of 75 mcg and 150 mcg of buprenorphine with 2% lignocaine hydrochloride as a local anaesthetic agent in mandibular molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis using heft-parker visual analogue scale.  intraoperative and 6, 12, 24, 48 hrs post operative 
 
Secondary Outcome  
Outcome  TimePoints 
Pain experience assessment   intraoperative and 6, 12, 24, 48 hrs post operative 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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 3 
Date of First Enrollment (India)   03/07/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Regardless of the advancements in innovation, the number of people experiencing dental pain remains relatively high. Amongst them, many require endodontic therapy for the relief of pain. Though the procedure prevails upon anxiety in some individuals, literature states that fear of pain and needles, failure of profound anesthesia, and anxiety are the major concerns.

Profound research has been investigated in endodontic pain management. A survey by the American Association of Endodontists (AAE) found that 67% of patients had fear of pain as their primary concern during endodontic therapy. A study by O¢Keefe stated that patients with moderate to severe preoperative pain are more analogous with intra and postoperatively during endodontic therapy. Pain management in endodontic therapy can be focused on either by blocking or reducing the nociceptive impulses or by preventing pain perception in the central nervous system. Thus, in many of the peripheral nerve block approaches, a short-acting local anesthetic with or without a vasoconstrictor is employed.

Endorphins are endogenous opioids produced naturally to provide analgesic effects. In inflammation, the opioid receptors are increased around the peripheral nerves. If an exogenous opioid is added to the local anesthetic agent to block the peripheral nerve, significant analgesia can be achieved during the procedure and postoperatively.

Buprenorphine is a partial agonist and antagonist opioid with the property of a ceiling effect. It has fewer side effects when compared to full-agonist opioids. An elimination half-life of 24–37 hours provides a significant duration of analgesia without motor or sensory blockade.

Peri-operative pain experienced by patients suffering from pulpitis is a major concern in endodontic therapy. To improve the patient’s compliance with post-operative sequelae, we intended to add Buprenorphine, a narcotic analgesic with a partial agonist and antagonist in action. With this addition to lidocaine, the post-operative analgesic effect can be prolonged.

The present study has chosen to use buprenorphine at two distinct concentrations, along with 2% lignocaine, in order to assess perioperative analgesia. Typically, a dose of 300 mcg of buprenorphine is included with the local anesthetic used in peripheral plexus blocks. Because the inferior alveolar nerve is smaller in diameter and in a highly vascularised area, a lower dose of 75 mcg and 150 mcg with 2% lignocaine will be used in this study.

However, a comprehensive review of the literature observed no studies that revealed the efficacy of mixing buprenorphine hydrochloride with lignocaine hydrochloride as a local anesthetic for endodontic therapy. Moreover, there were no reports comparing this combination of drugs with other local anesthetic agents.

Thus, the aim of this study is to compare the perioperative analgesic effect of buprenorphine hydrochloride combined with lignocaine hydrochloride during the treatment of mandibular molars with symptomatic irreversible pulpitis and symptomatic apical periodontitis.

 
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