| 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
|
|
|
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
|
|
|
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. | |