| 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
|
|
|
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
|
|
|
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 |
|
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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. |