| CTRI Number |
CTRI/2024/03/064923 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two orally given medicines on anesthesia of lower back tooth with infection |
|
Scientific Title of Study
|
Effectiveness of oral premedication on anesthetic success of Inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis using Dexamethasone and combination of Dexamethasone and Ibuprofen
A double blinded 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 |
Poojamol P V |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room Number 404
Department of Conservative Dentistry and Endodontics
Government Dental College
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8157994852 |
| Fax |
|
| Email |
poojamolpv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shoba K |
| Designation |
Professor and HOD |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room Number 404
Department of Conservative Dentistry and Endodontics
Government Dental College
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
9745205407 |
| Fax |
|
| Email |
drshobak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poojamol P V |
| Designation |
Junior Resident |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room Number 404
Department of Conservative Dentistry and Endodontics
Government Dental College
Kottayam
Kottayam
KERALA
686008
India |
| Phone |
8157994852 |
| Fax |
|
| Email |
poojamolpv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College
Gandhinagar P O
Kottayam
Pin code 686008 |
|
|
Primary Sponsor
|
| Name |
Poojamol P V |
| Address |
Padikkaparambil
Thrukothamangalam P O
Puthuppally
kottayam
Kottayam 686011 |
| Type of Sponsor |
Other [Self] |
|
|
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 Poojamol P V |
Government Dental College Kottayam |
Room Number 404
Department of Conservative Dentistry and Endodontics
Kottayam
KERALA |
08157994852
poojamolpv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College Kottayam |
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 |
Effectiveness of oral premedication on anesthetic success of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis using combination of dexamethasone and ibuprofen |
To evaluate the effect of oral premedication with combination of 800mg Ibuprofen and 0.5mg Dexamethasone on anesthetic success of Inferior Alveolar Nerve block in Mandibular molars with Symptomatic irreversible pulpitis. The medication is given orally once before local anesthetic administration |
| Intervention |
Effectiveness of oral premedication on anesthetic success of inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis using dexamethasone |
To evaluate the effect of oral premedication with 4mg Dexamethasone on anesthetic success of Inferior Alveolar Nerve block in Mandibular molars with Symptomatic irreversible pulpitis. The medication is given once orally before local anesthetic
administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult patients aged 18 to 45 years
Presence of irreversible pulpitis with moderate to severe pain in mandibular molars, without any
signs of periapical involvement.
Patients not taken analgesics for at least 12 hours before enrollment in the study |
|
| ExclusionCriteria |
| Details |
Patients with allergies and hypersensitivity to medications, local anesthetic solution, or its
components
Pregnant or nursing women
Immunocompromised patients
Patients with active sites of pathosis in the area of injection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Before premedication
15 minutes after LA
During File insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
During Access opening
During File insertion |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An Inferior Alveolar Nerve Block (IANB)is the standardized injection technique for mandibular molar teeth. However, IANB does not always result in successful pulpal anesthesia, especially in patients with Symptomatic irreversible pulpitis. The fact that patients often feel pain during endodontic treatment of teeth with Symptomatic irreversible pulpitis is a challenge for the clinician. Successful anesthesia is only achieved if no or minimal pain is achieved during access cavity preparation and canal shaping. Pain during access opening and instrumentation caused by anesthetic failure was even recorded in patients who had demonstrated positive signs of anesthesia such as numbness in the lower lip and the tip of the tongue. Thus, lip numbness was shown not to be always related to successful pulpal anesthesia. The Successful management of pain during root canal treatment is important for both patients and dentist. Various Studies have shown that the success rate of anesthesia for pain -free endodontic access and instrumentation in teeth with irreversible pulpitis can be increased by using Supplemental buccal infiltration, periodontal ligament injection, Intraosseous anesthesia and Oral premedication. Studies have shown that use of oral premedication with NSAIDS and Steroids improved the success rate of IANB in Symptomatic irreversible pulpitis. The purpose of this study is to evaluate the effect of oral premedication with 4mg Dexamethasone and combination of 800mg Ibuprofen and .5mg Dexamethasone on the anesthetic success of IANB in patients with Symptomatic irreversible pulpitis. |