| CTRI Number |
CTRI/2024/11/076382 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does Applying Cold Therapy along with anesthesia Help Nerve Blocks Work Better for Severe Tooth Pain ? A Clinical Study. |
|
Scientific Title of Study
|
Efficacy of cryotherapy as an adjunct to inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: A randomized 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 |
DrRicha Ratanrao Chaure |
| Designation |
MDS Student |
| Affiliation |
Bharati Vidyapeeth Deemed to be university Dental college and Hospital,,Pune |
| Address |
Room number 104,Department of conservative dentistry and endodontics,Bharati Vidyapeeth Deemed to be University Dental College And Hospital,Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9028181944 |
| Fax |
|
| Email |
richachaure123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarita Vikram Singh |
| Designation |
Associate Professor and Guide |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune |
| Address |
Room number 104,Department of conservative dentistry and endodontics,Bharati Vidyapeeth Deemed to be University Dental College And Hospital,Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9765746178 |
| Fax |
|
| Email |
sarita.sing@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrRicha Ratanrao Chaure |
| Designation |
MDS Student |
| Affiliation |
Bharati Vidyapeeth Deemed to be university Dental college and Hospital,,Pune |
| Address |
Room number 104,Department of conservative dentistry and endodontics,Bharati Vidyapeeth Deemed to be University Dental College And Hospital,Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9028181944 |
| Fax |
|
| Email |
richachaure123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University Dental College and Hospital,Satara road Pune(Maharashtra)India-411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital,Pune |
| Address |
Bharati Vidyapeeth Deemed to be University Dental College and Hospital,Satara road Pune(Maharashtra)India-411043 |
| 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 Richa Chaure |
Bharati Vidyapeeth Deemed to be Universty,Dental College & Hospital. Pune |
Room number 104
Department of Conservative Dentistry and Endodontics
Pune
MAHARASHTRA |
9028181944
richachaure123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth(Deemed to be University)Dental College and Hospital,Pune Institutional Ethics Comittee |
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 |
Local anesthesia |
Standard Inferior alveolar nerve block (IANB) will be administered using 3 ml of 2% lignocaine hydrochloride with adrenaline 1: 80000 deposited at a rate of 1 ml/min. The block will be administered with 26×1 ½ G long (38 mm) needle inserted slightly laterally at the middle portion of the pterygomandibular raphe to contact bone with the needle bevel directed towards bone, slightly withdrawn and aspirated and solution will be deposited. |
| Comparator Agent |
Local Anesthesia and cryotherapy |
After the access opening ice sticks (8 mm diameter and 2 cm length) will be carried with the help of tweezer and directly placed on the pulp chamber for a period of 4 min |
| Comparator Agent |
Local anesthesia and Cryotherapy |
In one group: small ice pack wrapped in sterile gauze will be applied on the buccal, lingual (3 sec/surface), and the occlusal surfaces (4 sec) for a total of 10 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with symptomatic irreversible pulpitis (SIP)in mandibular molars.
2. Patients of the age between 18-50 years.
3. Patients with a preoperative Visual Analog Scale (VAS) score greater than 4, indicating moderate to severe pain |
|
| ExclusionCriteria |
| Details |
1. Patients below age 18 and over age of 50 years
2. Cases of acute apical abscess and chronic apical abscess with or without sinus.
3. Teeth with calcified pulp chamber and root canals.
4. Previously filled root canals.
5. Periodontally compromised teeth.
6. Cases of necrotic pulp.
7. Medically compromised patients.
8. Patients with a recent history (within the past 21 hours) of taking analgesics, steroids, and/or antibiotics. 9. Any sensitivity or allergy to lignocaine
10. Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cryotherapy is as an adjunct to inferior alveolar nerve block in patients with symptomatic irreversible pulpitis to relive pain. By using the cryotherapy, other painful injections will be avoided to relieve the pain. |
Pain response of patient will be assessed at three time interval by VAS(visual analogue scale)on the same day-
1. preoperative
2. During access opening
3. After pulp extirpation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cryotherapy is another method to get effective pulpal anesthesia which is an important prerequisite for successful endodontic treatment. |
Pain response of patient will be assessed at three time interval by VAS(visual analogue scale)on the same day-
1. preoperative
2. During access opening
3. After pulp extirpation
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
02/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/12/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [richachaure123@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 01-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this study we will be comparing effect of local anesthesia alone and along with cryotherapy in the treatment of patients with symptomatic irreversible pulpitis. The purpose of this study is to provide painless rootcanal treatment to patients. |