| CTRI Number |
CTRI/2024/05/067668 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Comparing Pain Relief Methods for Tooth Nerve Treatment: Standard Nerve Block vs. Nerve Block with Extra Gum Injection vs. Nerve Block with Laser Therapy, Using 4% Articaine, in Patients with Severe Toothache in Lower Molars: A Randomized Clinical Study |
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Scientific Title of Study
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“Comparative evaluation of anesthetic efficacy of conventional Inferior alveolar nerve block (IANB) versus IANB with supplemental intraligamentary injection and IANB with low level laser therapy (LLLT) using 4% Articaine as an anesthetic agent in patients with Symptomatic irreversible pulpitis in mandibular molars: A Randomized clinical study.â€
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manalee Manish Mapara |
| Designation |
PG Student |
| Affiliation |
K M Shah dental college |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7383664845 |
| Fax |
|
| Email |
drmmapara23@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Professor and head |
| Affiliation |
K M Shah dental college |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Professor and head |
| Affiliation |
K M Shah dental college |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
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Source of Monetary or Material Support
|
| K M shah dental college and hospital, Sumandeep vidyapeeth University, Waghodia road, Vadodara, Gujarat, India
Pincode-391760 |
|
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Primary Sponsor
|
| Name |
Dr Manalee Mapara |
| Address |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760 |
| Type of Sponsor |
Other [self] |
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Details of Secondary Sponsor
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|
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nimisha Shah |
K m shah dental college |
8, Department of conservative dentistry and endodontics, K M Shah Dental college, Sumandeep Vidyapeeth University, Waghodia road, Vadodara, 391760
Vadodara
GUJARAT |
9998994299
nshsh7873@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
IANB with low level laser therapy (LLLT) |
firstly IANB using 4% Articaine will be induced using intraoral route with the speed of 1ml/min then low level laser therapy (LLLT) will be done using 980nm wavelength diode LASER. LASER will be set to pain therapy mode and activated at 0.5 watt power and will be applied for 30 seconds. |
| Intervention |
IANB with supplemental intraligamentary injection |
firstly IANB using 4% Articaine will be induced using intraoral route then supplemental intraligamentary injection will be given using 4% Articaine induced by intraoral route with speed of 1ml/min |
| Comparator Agent |
Inferior alveolar nerve block |
Inferior alveolar nerve block using 4% Articaine as an anesthetic agent induced by intraoral route with the speed of 1ml/min. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1)Systemically healthy patients (Category: American Society of Anaesthesiologists class 11. Systemically healthy patients (Category: American Society of Anaesthesiologists class 1
(2)Patients who will diagnose with symptomatic irreversible pulpitis with or without apical periodontitis giving prolonged response to cold test and positive response to electric pulp test in mandibular molars
(3)Patient who will actively experience moderate to severe pain pre operatively on VAS scale above 4 (on 0-10 point scale)
(4)only those patients ready to sign the consent form |
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| ExclusionCriteria |
| Details |
(1)Patients allergic to local anesthetics or known allergy to articaine
(2)Pregnant and lactating patients
(3)Patients taking any analgesics, sedatives, and antianxiety drugs on regular basis or before 24 hrs. of treatment
(4)Patient having necrosed tooth with sinus tracts/local gum swelling around the affected tooth
(5)Patients with severe periodontitis and poor oral hygiene |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Help the clinician to decide which method of IANB nerve block ( Only IANB, IANB with intraligamentary, IANB with LLLT) will provide better anesthetic efficacy in cases of symptomatic irreversible pulpitis in lower permanent molars |
30 min |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Help to know about the duration of onset of anesthesia using different supplemental techniques |
0-5 minutes, 6-10 minutes, 11-15 minutes |
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Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
03/06/2024 |
| 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 |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study is done to compare and evaluate the anesthetic efficacy of conventional IANB(Inferior alveolar nerve block) versus IANB WITH supplemental intraligamentary injection and IANB with low level laser therapy using 4% Articaine as an anesthetic agent in cases of symptomatic irreversible pulpitis in mandibular molar teeth. The outcome of this study will help clinician to decide which method of IANB will provide better anesthetic efficacy in cases of symptomatic irreversible pulpitis cases and will also help to know about duration of onset of anesthesia using different supplemental techniques. This findings hold promise for both patients and clinicians, offering benefits in pain reduction and enhanced comfort during dental procedures.
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