| CTRI Number |
CTRI/2019/03/018153 [Registered on: 18/03/2019] Trial Registered Prospectively |
| Last Modified On: |
26/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the effect of supplementary therapies on post-operative pain after single visit root canal treatment |
|
Scientific Title of Study
|
Comparative evaluation of the effect of cryotherapy, low level laser therapy and intraligamentary injection of dexamethasone on the onset and severity of post-treatment pain after single visit root canal treatment - a randomized 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 |
Sana Fatima |
| Designation |
MDS Student |
| Affiliation |
ITS Dental College Muradnagar |
| Address |
Department of Conservative Dentistry and Endodontics
I.T.S. Dental College Murad Nagar
Delhi- Meerut Road, Murad Nagar,
Ghaziabad-201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8791753268 |
| Fax |
|
| Email |
dentistsanafatima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Taneja |
| Designation |
Professor and Head of Department of Conservative Dentistry and Endodontics ITS Muradnagar |
| Affiliation |
ITS Dental College Muradnagar |
| Address |
Department of Conservative Dentistry and Endodontics
I.T.S. Dental College Murad Nagar
Delhi- Meerut Road, Murad Nagar,
Ghaziabad-201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9891688100 |
| Fax |
|
| Email |
drsonali_taneja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Fatima |
| Designation |
MDS Student |
| Affiliation |
ITS Dental College Muradnagar |
| Address |
Department of Conservative Dentistry and Endodontics
I.T.S. Dental College Murad Nagar
Delhi- Meerut Road, Murad Nagar,
Ghaziabad-201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8791753268 |
| Fax |
|
| Email |
dentistsanafatima@gmail.com |
|
|
Source of Monetary or Material Support
|
| I.T.S. Dental College Murad Nagar, Ghaziabad 201206 |
|
|
Primary Sponsor
|
| Name |
Sana Fatima |
| Address |
Department of Conservative Dentistry and Endodontics
I.T.S. Dental College Murad Nagar
Delhi- Meerut Road, Murad Nagar,
Ghaziabad-201206 |
| 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 |
| Sana Fatima |
ITS Dental College Muradnagar |
ITS Dental college, NH 58 Delhi Meerut Road Muradnagar Ghaziabad
Ghaziabad
UTTAR PRADESH |
08791753268
dentistsanafatima@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Committee of I.T.S Centre for Dental Studies and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gp 1,single visit root canal treatment |
Normal saline as final irrigant and mock laser therapy(placebo) |
| Intervention |
Groups 2,3,4 single visit root canal treatment with adjunctive therapies |
Gp2 Intraligamentary injection with dexamethasone therapy given before start of treatment, Gp3 Cryotherapy given during the treatment i.e. as final rinse after cleaning and shaping.Gp 4,LLLT given after root canal treatment
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with moderate to severe pain in mandibular molars and a diagnosis of symptomatic apical periodontitis needing a primary endodontic procedure |
|
| ExclusionCriteria |
| Details |
patients with systematic or allergic reactions,
root canal retreatment,
pregnancy,
a history of medication within 3 days for chronic pain or those compromising the immune response ,
any contraindication or sensitivity to corticosteroids,
failure to obtain authorization from patients,
internal or external resorption,
teeth with open apices,
or any accident or complication occurring during treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess post-operative pain using Visual Analogue Scale |
After 6,12,24,48 and 72 hours of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amount Of Analgesics used by the patients post operatively |
After 6,12,24,48 and 72 hours of treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2019 |
| Date of Study Completion (India) |
28/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
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
|
This study is a randomized, triple blind (patient,outcome assessor and data analyst), parallel group, placebo controlled trial which aims to compare and evaluate the efficacy of 3 modes of adjunctive therapies (namely cryotherapy, low level laser therapy and intraligamentary injection of dexamethasone) on onset and severity of post treatment pain after single-visit root canal treatment. According to previously published data, frequency of post operative endodontic pain ranges from 1.4 to 16% and sometimes up to 50% in some studies. The strategies recommended to prevent endodontic postoperative pain can be categorized as pharmacologic or nonpharmacologic. Cryotherapy affects the conduction capacity of nociceptors and activates thermoreceptors thereby blocking nociception within the spiral cord. In dentistry, cold application has been frequently utilised following intraoral surgical procedures for postoperative pain control. Studies have shown that supra periosteal infiltration or intraligamentary infiltration of dexamethasone can reduce or even prevent postoperative pain in patients. Low level laser therapy or LLLT exerts neuron-regenerative and anti-inflammatory effects to provide pain control. The most common and reliable method for evaluating the outcome of treatments is randomized controlled clinical trial (Elwood 1998), because of minimum confounders and maximum control over the trial environment. Therefore, this randomized controlled trial will be done to evaluate and compare the effect of 3 modes of adjunctive therapies (namely cryotherapy, low level laser therapy and intraligamentary injection of dexamethasone) on onset and severity of post treatment pain after single-visit root canal treatment. |