| CTRI Number |
CTRI/2017/03/008218 [Registered on: 27/03/2017] Trial Registered Prospectively |
| Last Modified On: |
06/10/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
effect of ice application on pain relief during root canal treatment |
|
Scientific Title of Study
|
Effect of Cold on Reducing Pain During Pulp Extirpation -A Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vishnupriya |
| Designation |
post graduate student |
| Affiliation |
meenakshi ammal dental college |
| Address |
Meenakshi Ammal Dental College and Hospital,
Alapakkam Main road, Maduravoyal , Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9791005463 |
| Fax |
|
| Email |
kvp_92@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Velmurugan |
| Designation |
prof and Head of the department |
| Affiliation |
Meenakshi Ammal Dental College |
| Address |
Room no- 9, Dept of Conservative dentistry and Endodontics, Meenakshi Ammal Dental College and Hospital,
Alapakkam Main road, Maduravoyal , Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9840164167 |
| Fax |
|
| Email |
vel9911@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
vishnupriya |
| Designation |
post graduate student |
| Affiliation |
meenakshi ammal dental college |
| Address |
Meenakshi Ammal Dental College and Hospital,
Alapakkam Main road, Maduravoyal , Chennai 95
Chennai
TAMIL NADU
600095
India |
| Phone |
9791005463 |
| Fax |
|
| Email |
kvp_92@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
Meenakshi Ammal Dental College and Hospital,
Alapakkam Main road, Maduravoyal , Chennai 95 |
|
|
Primary Sponsor
|
| Name |
Meenakshi Academy of Higher Education and Research Institute |
| Address |
Meenakshi Ammal Dental College and Hospital,
Alapakkam main road, Maduravoyal , Chennai 95 |
| 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 |
| Vishnupriya |
Meenakshi Ammal Dental College |
Room NO- 9 (PG Clinic) , Dept of Conservative Dentistry And Endodontics
Chennai
TAMIL NADU |
9791005463
kvp_92@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Meenakshi ammal dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients suffering from symptomatic irreversible pulpitis in lower molars , in need for endodontic treatment (root canal treatment), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
articaine group |
following inferior alveolar nerve block with lignocaine , 4% articaine is administered (0.5 ml) as buccal infiltration prior to endodontic treatment |
| Intervention |
cold group |
Cold application following inferior alveolar nerve with 2% lignocaine hydrochloride with adrenalin 1: 1,00,000.
Cold in the form of EndoIce (containing 1,1,1,4–tetrafluroethane at temperature of -500 C) is applied on the buccal and lingual surface of the tooth for 2.5 seconds/ surface following rubber dam isolation.
2. Following access opening, ice sticks 2 cm long cm, temperature range of 0 degree C to 10 degree C is applied within the pulp chamber for 2 mins.
|
| Comparator Agent |
control group - standard lignocaine group |
2% lignocaine hydrochloride with adrenaline will be given for nerve block and root canal treatment will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
2. Patients diagnosed with symptomatic irreversible pulpitis planned for endodontic treatment in mandibular molars. (VAS score > 4) |
|
| ExclusionCriteria |
| Details |
1. Age > 50 years.
2. Immature young permanent teeth.
3. Teeth that do not respond to traditional vitality tests.
4. Cases of necrotic pulp.
5. Medically compromised patients.
6. Patients under long term medications that influence pain threshold.
7. Patients with a history of intake of analgesics, steroids and / or antibiotics in the recent past 48 hours.
8. pregnant and lactating women |
|
|
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 |
| pain assessed using Visual analogue scale |
during pulp extirpation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain assessed ussing Visual Analogue Scale |
during access opening |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/04/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Adequate anesthesia is one of the fundamental requisite for a successful endodontic treatment. Standard inferior alveolar nerve block is the primary method to achieve anesthesia in mandibular posterior teeth. However optimal pulpal analgesia following single inferior alveolar nerve block, especially of an inflamed mandibular tooth remains a challenge with clinical studies. Vreeland et al reported a failure rate of 57% in mandibular molars after inferior alveolar nerve block 1. The cold application is one of the trusted first aid remedy in managing pain and inflammation practiced in the field of medicine . There is a proportional decrease in the velocity of impulse conduction in nerve fibres irrespective of its functional variations and vasoconstriction following cold application.2 Topical cold application on the injection site prior to palatal anesthesia and mandibular anesthesia significantly reduced the pain on injection 3,4. However, the effect of topical cooling in managing intraoperative pain has not been addressed. The purpose of this study is to determine whether cold application during root canal treatment will result in significant pain reduction during pulp extirpation. |