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CTRI Number  CTRI/2024/12/078326 [Registered on: 19/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison and evaluation of pain while giving intrapulpal injection in patients with painful pulpal conditions. 
Scientific Title of Study   Comparative Evaluation of Pain Perception while Administering Intrapulpal Injection in Mandibular Molars with Symptomatic Irreversible Pulpitis with Three Different Techniques: A Randomized Controlled 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  SHIVANSH AGGROHIYA 
Designation  POST GRADUATE STUDENT 
Affiliation  SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURUGRAM, HARYANA 122505 
Address  SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURUGRAM, HARYANA 122505

Gurgaon
HARYANA
122505
India 
Phone  8750868570  
Fax    
Email  shivanshaggrohiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SUMEET SHARMA 
Designation  PROFESSOR AND HEAD 
Affiliation  SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURUGRAM, HARYANA 122505 
Address  SGT Dental College Hospital and Research Institute Gurugram Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  9873122335  
Fax    
Email  drsharma.endo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SUMEET SHARMA 
Designation  PROFESSOR AND HEAD 
Affiliation  SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURUGRAM, HARYANA 122505 
Address  SGT Dental College Hospital and Research Institute Gurugram Haryana 122505

Gurgaon
HARYANA
122505
India 
Phone  9873122335  
Fax    
Email  drsharma.endo@gmail.com  
 
Source of Monetary or Material Support  
SGT Dental College Hospital and Research Institute Gurugram Haryana India 122505 
 
Primary Sponsor  
Name  SGT UNIVERSITY 
Address  SGT Dental College Hospital and Research Institute Gurugram Haryana 122505 
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 SHIVANSH AGGROHIYA  SGT Dental College Hospital and Research Institute  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences
Gurgaon
HARYANA 
8750868570

shivanshaggrohiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGT UNIVERSITY 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  1)Endo Ice and Ice stick 2)Benzocaine gel 3)Intrapulpal injection of local anesthetic agent   1)1 spray on wick of cotton for 5 mins intrapulpal 2) 1 drop of gel 5mins intrapulpal 3)0.5 ml injection intrapulpal 
Intervention  Comparison of different anesthetic agents  1.Intrapulpal injection with Endo Ice and Ice Stick 2.Intrapulpal injection with Benzocaine Gel 3. Intrapulpal injection alone 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)Mature permanent mandibular molars diagnosed with symptomatic irreversible pulpitis.
2)Patients who need supplemental anaesthesia (Patient with Endodontic Emergency During Treatment: HOT TOOTH)
 
 
ExclusionCriteria 
Details  1)Immunocompromised patients, pregnant and lactating females
2)Periodontally compromised teeth
3)In patient where tooth is un-restorable, inadequate length.
4)Patient with pulp necrosis, periapical radiolucency, sinus tract, periapical abscess.
5)Patients who had taken analgesics within 12 hours before root canal therapy
6)Patients with communication barriers hindering their understanding of the study procedures and requirements. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the efficacy of intrapulpal injection with endo-ice and ice stick, intrapulpal injection with benzocaine gel and intrapulpal injection alone in reducing pain perception during administration of intrapulpal injections for symptomatic irreversible pulpitis in mandibular molars.  During administration of intrapulpal injection 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the extent of pain relief achieved with each intrapulpal anesthetic technique.  Immediately after injection,
5minutes,
15minutes 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   31/12/2024 
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 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  

AIM:

To compare the pain perception in mandibular molars with Symptomatic Irreversible Pulpitis with three techniques viz Intrapulpal Injection with Endo Ice and Ice Sticks, Intrapulpal Injection with Benzocaine Gel and Intrapulpal Injection alone: A Randomized Controlled Trial

OBJECTIVE:

     1) To compare and evaluate the efficacy of intrapulpal injection with Endo Ice and Ice Stick, intrapulpal injection with Benzocaine Gel and intrapulpal injection alone in reducing pain perception during administration of intrapulpal injections for symptomatic irreversible pulpitis in mandibular molars.

2.    2) To evaluate the extent of pain relief achieved with each intrapulpal anesthetic technique.

METHODOLOGY:

30 patients with a non-contributory medical history, will be selected and divided Â·         into three groups.

GROUP 1 (n = 10)- Endo Ice and Ice stick application followed by Intrapulpal Injection

GROUP 2 (n = 10)- Benzocaine Gel application followed by Intrapulpal Injection

GROUP 3 (n = 10)- Intrapulpal Injection alone

Patients diagnosed with symptomatic irreversible pulpitis will receive standard IANB injections by using 1.8ml of 2% lidocaine with 1:80,000 epinephrine for the root canal treatment. The anaesthetic solution will be administered with a 27-G, long (31-mm) needle inserted slightly laterally at the middle portion of the pterygomandibular raphe to contact bone with the needle bevel directed toward the bone, slightly withdrawn, and aspirated, and solution will be deposited over a period of 60 seconds.

 

After 15 minutes of IANB, each patient will be asked whether his or her ipsilateral lip and tongue are numb. If profound lip numbness is not recorded within 15 minutes, the block will be considered unsuccessful, and the patient will be excluded from the study. When the ipsilateral lip and tongue numbness appear, the involved teeth will be isolated with a rubber dam, and a conventional access opening will be initiated.

 

Access opening will be done into the pulpal chamber using high- and low-speed instrumentation with light and intermittent pressure to minimize the patient’s discomfort.

 

In case of pain during access opening procedures, patient’s tooth will be classified under Endodontic Emergencies During Treatment as “HOT TOOTH” and the treatment procedure will be stopped. The patient will then be allocated to 1 of the 3 study groups using randomization method mentioned.

 

For GROUP 1, Endo-ice (1,1,1,2 tetrafluoroethane) will be applied for a total of 20 seconds (10 seconds on buccal and 10 seconds on lingual surface) of the affected tooth. Subsequently Ice Sticks will be placed directly in pulp chamber for 5 minutes and followed immediately by intrapulpal LA injection. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

 

For GROUP 2, after deroofing the pulp chamber, anaesthetic gel (20% Benzocaine) will be applied on exposed pulp for 5 minutes followed by intrapulpal injection. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

For GROUP 3, patient will be given intrapulpal injection alone. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

 

Anesthesia will be categorized as determined to be effective when the patient could tolerate continuation of the treatment.

 

The working length will be confirmed using an electronic apex locator and periapical radiographs. A glide path will be established with K-files up to a size #15, and the canals will be prepared using nickel titanium rotary files. Biomechanical preparation will be done and the root canal procedure will be carried out.

RESULTS: On going research
CONCLUSION: On going research 
 
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