| CTRI Number |
CTRI/2024/05/066981 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To Compare The Effectiveness Of Inferior Alveolar Nerve Block For Pain Management During Root Canal Treatment Using Lignocaine With Articaine And Cryotherapy as an adjunct |
|
Scientific Title of Study
|
To Evaluate And Compare The Efficacy Of Inferior Alveolar
Nerve Block In Symptomatic Irreversible Pulpitis Cases Using
Lignocaine With Articaine And Cryotherapy As An Adjunct, In Pain
Reduction During Endodontic Procedures - A Clinical 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 |
Ridha Iqbal |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9596951861 |
| Fax |
|
| Email |
ridhaiqbal5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ridha Iqbal |
| Designation |
Post Graduate Student (MDS) |
| Affiliation |
I.T.S Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9596951861 |
| Fax |
|
| Email |
ridhaiqbal5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, 201308, India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital And Research Centre |
| Address |
Room No 7, Department Of Conservative Dentistry And Endodontics, I.T.S Dental College, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh, 201308, India |
| 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 Ridha Iqbal |
I.T.S Dental College, Hospital And Research Centre |
Room No 7, Department Of Conservative Dentistry And Endodontics, Knowledge Park 3, Greater Noida, 201308
Gautam Buddha Nagar
UTTAR PRADESH |
9596951861
ridhaiqbal5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental college hospital and research centre institutional ethics 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 |
| Intervention |
standard Inferior alveolar nerve block with
lignocaine hydrochloride and
supplementary buccal
infiltration with
articaine
|
Topical anaesthetic gel will be applied for 60 sec at the site of injection prior to administration of IANB. Standard IANB with 2ml of 2% lignocaine hydrochloride with adrenaline 1:80000 and supplementary buccal infiltration with 2ml of 4% articaine with adrenaline 1:100000 will be administered. After 15 min success of anaesthesia will be confirmed with EPT. Access opening will be performed. After access opening pulp extirpation will be performed. The patient will be asked to quantify the pain at 3 intervals that is pre operative, during access opening and immediately after pulp extirpation. Root canals will be medicated with calcium hydroxide and temporarily sealed with IRM. NRS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. The endodontic treatment will be completed 1 week later. |
| Intervention |
cryotherapy |
Topical anaesthetic gel will be applied for 60 sec at the site of injection prior to administration of IANB. Standard IANB with 2ml of 2% lignocaine hydrochloride with adrenaline 1:80000 will be administered. After 15 min success of anaesthesia will be confirmed with EPT. Prior to access opening endo ice will be applied on buccal (3 sec), lingual (3 sec) and occlusal surface (4 sec) for total 10 sec. Access opening will be performed. Pulp will be exposed and deroofing will be done. Ice sticks will be directly placed on pulp chamber for a period of 4 min. After access opening pulp extirpation will be performed. The patient will be asked to quantify the pain at 3 intervals that is pre operative, during access opening and immediately after pulp extirpation. Root canals will be medicated with calcium hydroxide and temporarily sealed with IRM. NRS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. The endodontic treatment will be completed 1 week later.
|
| Comparator Agent |
standard Inferior alveolar nerve block using
lignocaine hydrochloride with
adrenaline |
Topical anaesthetic gel will be applied for 60 sec at the site of injection prior to administration of IANB. Standard IANB with 2ml of 2% lignocaine hydrochloride with adrenaline 1:80000 will be administered. After 15 min success of anaesthesia will be confirmed with EPT. Access opening will be performed. After access opening pulp extirpation will be performed. The patient will be asked to quantify the pain at 3 intervals that is pre operative, during access opening and immediately after pulp extirpation. Root canals will be medicated with calcium hydroxide and temporarily sealed with IRM. NRS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. The endodontic treatment will be completed 1 week later.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with symptomatic irreversible pulpitis (SIP) planned for endodontic treatment in mandibular molars. Patients within the age group of 20–50 years. Teeth responding to cold and EPT test with lingering pain sensation for more than 30 sec. Preoperative NRS score greater than 4 (Moderate to severe pain). Patient consenting to be a part of this study. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study. Age less than 20 years and more than 50 years. Patients allergic to lignocaine or articaine. Immature young permanent teeth. Teeth that do not respond to vitality tests (Cold test and EPT). Acute and chronic alveolar abscess. Calcified pulp chamber and root canals. Previously filled root canals. Periodontally compromised teeth. Medically compromised patients. Patients with a history of intake of analgesics, steroids or antibiotics in the recent past 48 h. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy of IANB with 2% lignocaine hydrochloride , lignocaine with
articaine and cryotherapy as an adjunct in symptomatic irreversible pulpitis cases. |
The patient will be asked to quantify the pain at 3 intervals i.e pre operative, during access opening and
immediately after pulp extirpation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of IANB with 2% lignocaine hydrochloride , lignocaine with
articaine and cryotherapy as an adjunct in symptomatic irreversible pulpitis cases. |
The patient will be asked to quantify the pain at 3 intervals i.e pre operative, during access opening and
immediately after pulp extirpation |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study will be done to evaluate and compare the efficacy of inferior alveolar nerve block in symptomatic irreversible pulpitis cases using lignocaine with articaine and cryotherapy as an adjunct, in pain reduction during endodontic procedures. The forthcoming clinical study will be carried out within the Department of Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater Noida, Uttar Pradesh. The sample size for the study will encompass a total of 150 patients drawn from the Outpatient Department (O.P.D) of the Department of Conservative Dentistry and Endodontics, adhering meticulously to predefined inclusion and exclusion criteria. Patients will be screened according to the degree of baseline pain which will be determined before the selection of the sample using numerical rating scale (NRS). If a patient met all the inclusion criteria, he/she will be informed of the nature of the study and will be invited to participate by signing the consent forms. Patients will be then allocated to 3 groups of 50 patients each receiving standard inferior alveolar nerve block with lignocaine, standard inferior alveolar nerve block with lignocaine hydrochloride and supplementary buccal infiltration with articaine, Standard inferior alveolar nerve block with lignocaine hydrochloride followed by application of endo ice and ice sticks during access opening. The patient will be asked to quantify the pain at 3 intervals i.e pre operative, during access opening and immediately after pulp extirpation. NRS scale will be used to evaluate the intensity of pain experienced by the patients on a scale of 0-10. |