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CTRI Number  CTRI/2024/11/076797 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Taking Meloxicam Before a Lidocaine and Epinephrine Injection, Combined with Mannitol, Affects Pain Relief in Dental Nerve Blocks: A Study 
Scientific Title of Study   Effect Of Premedication With Meloxicam on Anaesthetic Efficacy of A Combination of Mannitol Plus LIdocaine With Epinephrine In Inferior Alveolar Nerve Block: A Randomized Control Trial  
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 Shivi Agarwal 
Designation  MDS Students Of Conservative Dentistry And Endodontics 
Affiliation  ITS -CDSR, GHAZIABAD 
Address  Department of Conservative Dentistry And Endodontics ITS- CDSR, Delhi Meerut Road Muradnagar, Ghaziabad, UP 201206

Ghaziabad
UTTAR PRADESH
201206
India 
Phone  7300868985  
Fax    
Email  agarwalshivi31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonali Taneja  
Designation  PROFESSOR, HOD, DEAN-PG STUDIES 
Affiliation  ITS-CDSR, MURADNAGAR 
Address  Department of Conservative Dentistry And Endodontics ITS- CDSR, Delhi Meerut Road Muradnagar, Ghaziabad, UP 201206

Ghaziabad
UTTAR PRADESH
2012026
India 
Phone  9891688100  
Fax    
Email  Sonalitaneja@its.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Soanli Taneja  
Designation  PROFESSOR, HOD, DEAN-PG STUDIES 
Affiliation  ITS-CDSR, MURADNAGAR 
Address  Department of Conservative Dentistry And Endodontics ITS- CDSR, Delhi Meerut Road Muradnagar, Ghaziabad, UP 201206

Ghaziabad
UTTAR PRADESH
2012026
India 
Phone  9891688100  
Fax    
Email  Sonalitaneja@its.edu.in  
 
Source of Monetary or Material Support  
ITS Centre For Dental Studies And Research, Muradnagar, Ghaziabad 
 
Primary Sponsor  
Name  Dr Shivi Agarwal 
Address  ITS Centre For Dental Studies And Research, Muradnagar, Ghaziabad, 201206 
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 Shivi Agarwal  ITS Centre for Dental Studies and Research  Room no.6, PG Clinic, Department of Conservative Dentistry And Endodontics ITS-CDSR, Delhi Meerut Road Muradnagar, Ghaziabad, UP 201206
Ghaziabad
UTTAR PRADESH 
7300868985

agarwalshivi31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ITS INSTITUTIONAL ETHICS COMITTEE(IIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lidocaine Epinephrine  The intervention consists of a single administration of 2% lidocaine with 1:80000 epinephrine combined with 0.5 mol/L mannitol, with or without a 15 mg meloxicam premedication, provided in a single sitting for root canal treatment. This group receives the local anesthetic (lidocaine with epinephrine) alongside mannitol to enhance anesthetic diffusion, and meloxicam is used to reduce inflammation and potentially improve anesthetic effectiveness. 
Comparator Agent  Mannitol Meloxicam  GROUP 1: 1.5mL Formulation Containing 2% Lignocaine with Epinephrine (Control) GROUP 2: 1.5 mL Formulation Containing 2% Lignocaine with 1: 80000 Epinephrine And 0.5 Mol/L Mannitol GROUP 3: 1.5 mL Lignocaine with 1:80000 Epinephrine and Premedication- Meloxicam 15mg GROUP 4: 1.5 mL Lignocaine with 1: 80000 Epinephrine, 0.5 Mol/L Mannitol and Premedication- Meloxicam 15mg  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged 18-65 years with a vital, painful mandibular posterior tooth and a prolonged response to cold testing 
 
ExclusionCriteria 
Details  AGE OUTSIDE 18-65, ALLERGIES TO SPECIFIC SUBSTANCES,PREGNANCY, SIGNIFICANT MEDICAL CONDITIONS, CERTAIN MEDICATIONS, ACTIVE PATHOSIS AT THE INJECTION SITE, OR INABILITY TO GIVE INFORMED CONSENT  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the effect of premedication with meloxicam on the anaesthetic efficacy of a combination of mannitol plus lidocaine with epinephrine in inferior alveolar nerve blocks  Baseline, 6,12,24,72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
TO ASSESS THE ONSET TIME, DURATION OF ANESTHESIA, AND PATIENT COMFORT   Baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/11/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Patients with symptomatic irreversible pulpitis often face significant challenges in achieving effective anesthesia with inferior alveolar nerve (IAN) blocks. Failure rates for IAN blocks in such cases can be as high as 44% to 81%, largely due to the perineural barrier, which restricts the diffusion of anesthetic agents into the nerve trunk. The innermost layer of this barrier, known as the perilemma, acts similarly to the blood-brain barrier, presenting a formidable obstacle to complete anesthetic effectiveness. Inflammation associated with irreversible pulpitis may sometimes disrupt this barrier, temporarily increasing its permeability and improving anesthetic outcomes. However, this effect is unpredictable, prompting research into adjunctive agents that could more consistently enhance anesthesia.

Mannitol, a hyperosmolar sugar alcohol solution, has shown potential in overcoming restrictive barriers like the blood-brain barrier in other medical applications, such as treating cerebral edema. Mannitol works by temporarily increasing the permeability of the perineural membrane, thus potentially allowing more anesthetic to penetrate the nerve trunk. In the context of IAN blocks, mannitol could serve as a valuable addition to lidocaine with epinephrine, making it easier for the anesthetic to reach and affect nerve fibers. Initial studies suggest that when mannitol is used alongside lidocaine, the anesthetic effect may be enhanced, providing better pain control in patients who would otherwise remain sensitive to pain during endodontic procedures.

Additionally, meloxicam, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), offers a promising role as a premedication. Unlike other NSAIDs, meloxicam reduces inflammation with a lower risk of gastrointestinal side effects, making it suitable for short-term preoperative use. In cases of pulpitis, local inflammation exacerbates pain and increases resistance to anesthesia. Meloxicam’s anti-inflammatory effects could help lower this resistance by reducing inflammation around the affected tooth, enhancing the overall depth and duration of anesthesia. Although limited studies have examined meloxicam’s specific effect on dental anesthesia, its potential to support anesthetic efficacy makes it an intriguing option for managing difficult cases of pulpitis.

To accurately assess the combined efficacy of mannitol and meloxicam, the study employs electric pulp testing (EPT) and cavity testing as primary outcome measures. EPT offers an objective way to gauge pulpal anesthesia by measuring the tooth’s response to electric stimuli, while cavity testing directly assesses pain response during the dental procedure. Together, these methods provide a reliable assessment of anesthetic success, reflecting not only numbness but also the absence of pain under challenging conditions.

If successful, this approach could set a new standard for anesthetic protocols in endodontics, particularly for patients with symptomatic irreversible pulpitis who often experience pain despite typical anesthesia signs, such as lip numbness. By enhancing anesthetic effectiveness with mannitol and premedicating with meloxicam, clinicians could achieve a more profound and consistent anesthesia, making dental procedures more comfortable for patients with inflamed pulpal tissue. This innovative protocol has the potential to significantly reduce treatment challenges and improve patient outcomes, providing a promising solution in cases where traditional anesthetic techniques have frequently fallen short.

 
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