| CTRI Number |
CTRI/2021/10/037571 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
25/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
a clinical study of cold application after main block using 4% articaine in acute dental pain of mandibular molar teeth. |
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Scientific Title of Study
|
Efficacy of Endo-Ice intrapulpal application after inferior alveolar nerve block and articaine buccal infiltration in patients with symptomatic irreversible pulpitis of mandibular molars—a randomized placebo controlled trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UMESH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
post graduate institute of medical education and research |
| Address |
room no. 101, division of conservative dentistry and endodontics, department of oral health science centre, post graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
UMESH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
post graduate institute of medical education and research |
| Address |
room no. 101, division of conservative dentistry and endodontics, department of oral health science centre, post graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
UMESH KUMAR |
| Designation |
Associate Professor |
| Affiliation |
post graduate institute of medical education and research |
| Address |
room no. 101, division of conservative dentistry and endodontics, department of oral health science centre, post graduate institute of medical education and research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09862969792 |
| Fax |
|
| Email |
odharmani911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of medical education and research |
|
|
Primary Sponsor
|
| Name |
Dr Umesh Kumar |
| Address |
Department of Oral Health Science Centre,PGIMER, CHANDIGARH |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| UMESH KUMAR |
PGIMER |
room no. 101,Ohsc, pgimer,chandigarh
Chandigarh
CHANDIGARH |
9862969792
odharmani911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER, Institute Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, (2) ICD-10 Condition: K040||Pulpitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
endo ice |
lignocaine (2%) adrenaline (1:80000)+buccal infiltration with articaine (4%) with adrenaline (1:100000) and intra-pulpal cold application with endo ice. |
| Comparator Agent |
lignocaine |
lignocaine (2%) adrenaline (1:80000)+buccal infiltration with articaine (4%) with adrenaline (1:100000) and intra-pulpal cold application with endo ice. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria for the study were as follows: moderate to severe pain in the mandibular first molar, a prolonged response to cold testing with an ice stick and an electric pulp tester (Kerr Pulp Tester; Analytic Technology Corp, Redmond, WA), the absence of any periapical radiolucency on radiographs except for a widened periodontal ligament, a vital coronal pulp on access opening, and the ability of the subject to understand the use of pain scales. The subjects were in good health, and none were taking any medication that would alter pain perception, as determined by oral questioning and a written questionnaire. |
|
| ExclusionCriteria |
| Details |
The exclusion criteria for the study were as follows: subjects younger than 18 years of age or older than 50 years of age, any known sensitivity to either 2% lidocaine or 4% articaine or epinephrine, patients having active pain in more than 1 mandibular molar, subject taking any pain-relieving medication including over-the-counter analgesics at least 12 hours before enrollment in the study, and swelling near the tooth in question and having a tooth not suitable for simple restorative treatment because of extensive caries or periodontal problems. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| endo ice efficacy as intra pulpal anesthetic agent in patient with symptomatic irreversible pulpitis after IANB with 2% lidocaine and buccal infiltration with 4% articaine. |
1 hour |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of primary block IANB with 2% lidocaine and buccal infiltration with 4% articaine as intrapulpal anaesthesia |
30 minutes |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the present study is to evaluate the effect of Endo-Ice followed by intrapulpal ice application for reducing pain during pulp extirpation in mandibular molars with symptomatic irreversible pulpitis. Sixty six adult volunteer subjects will be selected from dental OPD. The subjects should be actively experiencing pain and in good health and will be randomly divided into three groups twenty each. Patients will mark their pretreatment pain on a 170-mm HP VAS (12). Patients will receive in Control group—inferior alveolar nerve block with lignocaine (2%) adrenaline (1:80000), buccal infiltration of 4% articaine with adrenaline (1:100000) and intra-pulpal injection using normal saline as placebo. Lidocaine group- inferior alveolar nerve block with lignocaine (2%) adrenaline (1:80000)+buccal infiltration with articaine (4%) with adrenaline (1:100000) and intra-pulpal injection using 2% lidocaine; Endo Ice group—inferior alveolar nerve block with lignocaine (2%) adrenaline (1:80000)+buccal infiltration with articaine (4%) with adrenaline (1:100000) and intra-pulpal cold application with endo ice. The patients will be asked to rate their pain on HP VAS after 15 minutes of the infiltration during the conventional access opening procedure after rubber dam application. Success will be defined as no pain or weak/mild pain during endodontic access preparation and instrumentation (Heft-Parker VAS score<55mm). Age with initial and post injection pain of the subjects will be evaluated using multiple comparison analyses of variance (Kruskal-Wallis) and t tests at P < .05. Anesthetic success of all groups will be compared by using nonparametric chi-square χ2 test. |