| 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
|
|
|
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
|
|
|
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. |
|
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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 · 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 |