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CTRI Number  CTRI/2024/07/070517 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of tramadol hydrochloride and lignocaine in symptomatic irreversible pulpitis. 
Scientific Title of Study   Comparative Evaluation of Perioperative Analgesic and Anaesthetic Efficacy in Supraperiosteal Infiltration of Tramadol Hydrochloride in patients with Symptomatic Irreversible Pulpitis – A Triple-blind randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalyaneswari Roopini R 
Designation  Post Graduate student 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics Out patient department 2nd floor Ramapuram Chennai
SRM Dental College Bharathi Salai TAMIL NADU India
Chennai
TAMIL NADU
600089
India 
Phone  9962556015  
Fax    
Email  ra6893@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Amirtharaj L 
Designation  Associate Professor 
Affiliation  SRM Institute of Science and Technology  
Address  Department of Conservative Dentistry and Endodontics Out patient department 2nd floor Ramapuram Chennai
SRM Dental College Bharathi Salai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9884111167  
Fax    
Email  vijaya1@srmist.edu.in  
 
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 Ramapuram Chennai
SRM Dental College Bharathi Salai TAMIL NADU 600089 India
Chennai
TAMIL NADU
600089
India 
Phone  9381018598  
Fax    
Email  researchmaha@gmail.com  
 
Source of Monetary or Material Support  
SRM Dental College Bharathi salai, Ramapuram, Chennai-600089, Tamilnadu, India. 
 
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 Kalyaneswari Roopini R  SRM Dental College   Department of Conservative Dentistry and Endodontics, Out Patient Department 2nd Floor, SRM Dental College, Bharathi Salai, Ramapuram, Chennai TAMIL NADU 600089.
Chennai
TAMIL NADU 
9962556015

ra6893@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRMDC Institutional Review Board and Institutional Ethical Committee  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 
Comparator Agent  2% (20mg/ml)Lignocaine Hydrochloride  Supraperiosteal infiltration(Infiltration anaesthesia) of 2% (20mg/ml) lignocaine with 1:80.000 epinephrine will be administered at the buccal side with respect to the maxillary molar alveolar region and evaluation of onset and duration of anaesthesia, analgesic effect during and 6,12,24,48 hr postoperatively. 
Intervention  50 mg/ml Tramadol Hydrochloride   Supraperiosteal infiltration(Infiltration anaesthesia) of tramadol HCL (50 mg/mL) solution will be administered at the buccal side with respect to the maxillary molar alveolar region and evaluation of onset and duration of anaesthesia, analgesic effect during and 6,12,24,48 hr postoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  ASA I
Pain severity with HP-VAS (85mm above) in maxillary molars.
 
 
ExclusionCriteria 
Details  ASA II and above
Patients with allergy, sensitivity or side effects to tramadol or any opioid drugs.
Negative response to electric pulp testing.
Periodontally compromised teeth.
Patients with bleeding disorders.
Calcified root canals, root resorption, open apex or unrestorable teeth.
Patients who consumed analgesics or antibiotics within 24 hours before the treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To comparatively assess the perioperative analgesic efficacy of tramadol hydrochloride as a local anaesthetic agent in maxillary molars with symptomatic irreversible pulpitis using heft-parker visual analogue scale and brief pain inventory assessment tool.  Intraoperative and 6, 12, 24 and 48 hr postoperative. 
 
Secondary Outcome  
Outcome  TimePoints 
Perioperative analgesic efficacy  6, 12, 24 & 48 hr postoperative. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   26/07/2024 
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="1"
Months="0"
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  
 

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage (Raja SN et al., 2020). Symptomatic irreversible pulpitis is generally considered to be the most difficult condition in dentistry with respect to pain control during and after treatment. Management of pain in symptomatic irreversible pulpitis is often an emergency condition that requires immediate treatment (Abbott et al., 2018). These teeth exhibit intermittent or spontaneous pain and are sensitive to thermal stimulus. Rapid exposure to dramatic temperature changes (especially to cold stimuli) will elicit heightened and prolonged episodes of pain even after the thermal stimulus has been removed (Berman LH, Hargreaves KM, 2020). Local anesthetics are used alone or in combination with adjuncts for pain control during the endodontic treatment of irreversible pulpitis. One of the most widely used methods to administer local anesthetics in maxillary teeth is local infiltration anesthesia.

Local anesthetics often fail to achieve adequate pain control in inflamed teeth, as it causes metabolic acidosis which lowers the tissue pH; greater fraction of the local anesthetic in the ionized form hindering diffusion into the axolemma (Tripathy KD, 2019). Nusstein et al. reported that only 68% patients had no pain following buccal infiltration injections in the treatment of maxillary teeth (Nusstein et al.,1998).

In maxillary molars, it has been shown that pain associated with treating the pulp in the palatal canal is the commonest reason for inadequate anaesthesia in teeth with irreversible pulpitis. The length of the roots, the presence of bone and maxillary sinus reduces the volume of the anaesthetic drug that reaches the targeted nerves (Ulusoy et al., 2013). Adjuvants or additives are often used with local anesthetics for its synergistic effect by prolonging the duration of sensory/motor block and limits the cumulative dose requirement of local anesthetics. A large array of adjuvants which include vasoconstrictors like adrenaline, alpha 2 adrenoreceptor antagonists like clonidine, dexmedetomidine, steroids like dexamethasone, benzodiazepine like midazolam, NMDA receptor antagonists like ketamine and magnesium sulphate, opioids like morphine, fentanyl, sufentanyl and tramadol have been used in medicine and surgery with varying degrees of success (Swain et al. 2017). Recent in vitro studies have shown that few opioids have anaesthetic effects (Jaffe R A et al., 1996). One of these opioids is tramadol hydrochloride, a centrally acting synthetic opioid analgesic indicated for moderate-severe pain management (Srivastava et. al., 2019).

Tramadol and its metabolite O-desmethyl-tramadol (M1) are agonists of the μ opioid receptor. Tramadol inhibits serotonin reuptake and inhibits nor-epinephrine reuptake, enhancing inhibitory effects on pain transmission in the spinal cord. The complementary and synergistic actions of the two enantiomers improves the analgesic efficacy (Grond et al., 2004). The analgesic effect of tramadol is also mediated via indirect modulation of the central monoaminergic inhibitory pain pathways. (Power et al., 1991). Pang et al. reported the local anaesthetic effect of tramadol when injected intradermally and reduces propofol injection pain. Jendi et al evaluated the soft tissue anaesthesia produced by tramadol hydrochloride on gingival tissues in maxilla and concluded that tramadol has a local anaesthetic effect similar to lignocaine when injected as infiltration in oral soft tissues and can be used as an alternative to conventional local anaesthetic agents in minor oral surgical procedures.  In dentistry, tramadol was added to known anaesthetic agents and the combined effect was investigated. In one study, Pozos et al. used 4% articaine with 1: 100,000 epinephrine to provide mandibular anaesthesia in third molar extraction and also administered tramadol 50 mg/mL into the surgical site. Aksoy et al. evaluated the effects of submucosal tramadol on the success of inferior alveolar nerve blocks during root canal treatment of mandibular molars with symptomatic irreversible pulpitis. Al Haideri reported that tramadol alone or in combination with adrenaline can be used as a local anaesthetic for the extraction of upper molar tooth under supraperiosteal infiltration. Tramadol has been used as a sole local anaesthetic agent for dental extraction of upper teeth and is recommended as an alternative to conventional local anaesthetic agents (Haideri et al., 2013). However, an overall review of the literature revealed that there were no studies stated the efficacy of tramadol by itself as a sole local anaesthetic agent used for endodontic therapy, nor there were any reports comparing it with other local anaesthetic agents. 

Hence the aim of this in vivo study is to comparatively evaluate the perioperative analgesic and anaesthetic efficacy of pure tramadol with lignocaine during the endodontic management of maxillary molars with symptomatic irreversible pulpitis.

 

                                                                                                                                                                                                                                                             
 
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