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CTRI Number  CTRI/2023/11/060116 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 20/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of long acting anesthetic on pain during and after root canal treatment  
Scientific Title of Study   Effect of long acting supplementary local anesthetic on intra and post operative pain in single visit root canal treatment – a randomised control trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Apeksha Rao  
Designation  PG Student 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics, Room no 6, Vokkaligara Sangha Dental College and Hospital, Bangalore

Bangalore
KARNATAKA
560004
India 
Phone  8050956884  
Fax    
Email  rao.apeksha97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anitha R Kumari 
Designation  Guide 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics, Room no 6, Vokkaligara Sangha Dental College and Hospital, Bangalore

Bangalore
KARNATAKA
560004
India 
Phone  9845919324  
Fax    
Email  anithamanasi18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Apeksha Rao  
Designation  PG Student 
Affiliation  Vokkaligara Sangha Dental College and Hospital 
Address  Department of Conservative Dentistry and Endodontics, Room no 6, Vokkaligara Sangha Dental College and Hospital, Bangalore


KARNATAKA
560004
India 
Phone  8050956884  
Fax    
Email  rao.apeksha97@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Room no 6, Vokkaligara Sangha Dental College and Hospital, Bangalore for infrastructural support 
 
Primary Sponsor  
Name  Dr Apeksha Rao 
Address  room no 6, department of conservative dentistry and endododntics, Vokkaligara Sangha Dental College and Hospital, Bangalore-560004 
Type of Sponsor  Other [self sponsor] 
 
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 Apeksha Rao  Vokkaligara Sangha Dental College And Hospital  Department of Conservative Dentistry and Endodontics, Room no 6
Bangalore
KARNATAKA 
8050956884

rao.apeksha97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kempegowda Institute of Medical science, Institutional ethics committee, bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lignox A  2% Lignocaine 1:80,000 epinephrine for a duration of 48 hours 
Intervention  Ropin  0.5% Ropivacaine for a duration of 48 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who require endodontic treatment in Single rooted pre molar teeth with a clinical diagnosis of symptomatic irreversible pulpitis or symptomatic apical periodontitis
Patients giving history of spontaneous, continuous, lingering, gnawing or throbbing type of pain with a VAS score > 6.
On cold vitality testing, eliciting response of lingering pain, delayed or negative response
Only one teeth involved in the quadrant
Teeth without anatomic variations, for example, receded pulp chamber, calcified canals, or sharply curved canals
Patients not on analgesics or sedative medications 24-48hrs before root canal therapy
 
 
ExclusionCriteria 
Details  Patients with known allergy to anaesthetics
Asymptomatic irreversible pulpitis and other pulpal or periodontal disease diagnosis
Patients who are diabetic, pregnant or any other systemic illness
Retreatment
 
 
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 
intra operative and post operative pain assessment using VAS scale  2,6,12,24,48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
intro operative and post operative pain assessment difference in age and gender using VAS scale and use of post operative analgesic  2,6,12,24,48 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   30/11/2023 
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="0"
Days="30" 
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  

The main rationale of endodontic treatment is the elimination of microorganisms from the infected root canal system by adequate chemo mechanical debridement followed by a three dimensional obturation to achieve hermetic seal that will promote healing in the periradicular region. 1

 

There are various factors associated with the occurrence of pain during and post endodontic treatment such as the condition of pulp and periradicular tissues before treatment, immune system mediated phenomena, psychological factors, level of pre-operative pain, periapical tissue pressure etc. Which in confluence with iatrogenic factors such as inadequate root canal instrumentation, extrusion of periapical debris, type of files used in endodontic treatment etc.2

 

The pain accompanying endodontic treatment, despite being considered as a poor indicator of pathology and unreliable predictor for the long term success of root canal treatment, needs to be addressed as it could have sustained impact on the patient’s mental perception of root canal treatment.

 

Moderate to severe pain during endododntic treatment has ranged from 11% to 35% and even as high as 100% as reported by Abbot et at, 2018 3. Intra-operative pain management in endodontics centers around the achievement of profound local anesthesia. Unfortunately, patients suffering from severe pain of endodontic origin, particularly symptomatic irreversible pulpitis, may experience difficulties in achieving adequate pulpal anesthesia due to issues with techniques, altered ph, or inflammation of the surrounding tissues resulting in pharmacologic failure. Since neither patients nor providers wish to experience breakthrough pain during treatment, and poor past experiences can lead patients to avoid dental care in the future, it is imperative that clinicians provide pain-free care.4

 

The time, volume, type of aneasthetic including additives as well as use of supplemental techniques have been employed in controlling peri operative pain. Meechan in 2002, reported that in 80% of patients with irreversible pulpitis, the inferior alveolar block is ineffective. Supplementary injections have proven to aid in achieving substantial anaesthetia. The use of supplementary intra pdl injections resulted in 56–70% having successful anaesthesia. The findings support the pursuit of an effective pain management solution during endodontic treatment.5

 

Managing postoperative pain can be one of the more challenging aspects of clinical practice in endodontics and one by which the skill of the clinician is often judged. Good anesthetic technique could eliminate pain during the procedure, but post treatment endodontic pain remains a significant predicament to date.6

 

The incidence of this post endodontic pain (PEP), as reported by Sathorn et al, 2008 7, ranges from 3 - 58%. Pak and White et al, 2011 8, concluded that the prevalence of PEP was 40% at 24 hours, whereas it reduced to 11% at 1 week and it was most intense in the first six hours following a gradual decline after a week.

 

Several strategies have been adopted to manage the PEP such as premedication using corticosteroids, prophylactic analgesics, occlusal reduction, cryotherapy etc. The effects of these strategies on short as well as long term prevention of pain caused due to endodontic treatment has been studied extensively to determine the most suitable protocol to alleviate pain caused due to endodontic treatment. PEP is usually controlled by the use of mild oral analgesics or nonsteroidal anti-inflammatory drugs. However, nonsteroidal anti-inflammatory drugs may manifest side effects such as gastrointestinal irritation, systemic bleeding tendency, and allergic reactions. These observations justify efforts to find a method of postoperative pain control that does not provoke side effects.

 

A considerable number of literatures on intraligamentary anaesthetic technique (ILA) as alternative technique for inferior alveolar nerve block (IANB) were generated over the last years. ILA only requires an injection directly into the periodontal space of the tooth with relatively high pressure. The injected solution spreads to the cancellous bone adjacent to the tooth to be anesthetized. This results in a localized area of anesthetization, without the ill effects of nerve block with soft tissue anesthesia.

 

Among the advantages of this technique are the rapid onset of action, a reasonable duration of 30–49 min, for generally employed lignocaine which is in line with standard dental treatment, as well as a low and safe amount of anesthetic solution (about 0.2 ml for each root). It is of high safety in pediatric patients, patients with bleeding disorders as well as in medically compromised patients.9

 

Ropivacaine, a long-acting anesthetic, having an onset of action of 2-4 mins, demonstrates a duration of anesthesia ranging between 7 and 11 h for inferior alveolar nerve block and a mean of 9 h for infiltration.10 Hypothetically, this extended duration of anesthesia covers the time of greatest incidence and intensity of postoperative pain following endodontic therapy.

 

Most of the evidence based on PubMed search is on the effect of using long‑acting anesthetic on postoperative pain after tooth extraction or periodontal surgery, and this is why such a study is important where the model used is on postoperative pain after RCT. 11,12 Further, there is minimal clinical research into the comparison of incidence of postoperative pain following single visit endodontics between patients anesthetized with lignocaine and ropivacaine with use of supplementary technique of ILA.Hence, an in vivo double‑blind study is proposed to evaluate the effect of supplementary intraligamentary ropivacine on intra as well as post-operative pain in single visit root canal treatment in teeth with symptomatic irreversible pulpitis and to compare the observations of both groups.

 

The study hypothesis proposed is as follows:

Null hypothesis (H0) – There is no difference in incidence of postoperative pain in single sitting RCT under lignocaine alone as IANB , LIOGNOCAINE as a supplementary ILA and ropivacaine as a supplementary ILA and used as local anesthetic agent.

 
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