| CTRI Number |
CTRI/2024/11/076944 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate effectiveness of cold application in addition to articaine injection in patients with painful pulpal condition |
|
Scientific Title of Study
|
Randomized Controlled Trial to Evaluate the Anaesthetic Efficacy of Cryotherapy Application as an Adjunct to Articaine in Patients with Symptomatic Irreversible Pulpitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KHUSHBU |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
GURUGRAM, HARYANA 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9868226062 |
| Fax |
|
| Email |
khushbubarak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHTHA ARYA |
| Designation |
MDS, PhD, PROFESSOR |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
GURUGRAM, HARYANA 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
ashtha.arya@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHTHA ARYA |
| Designation |
MDS, PhD, PROFESSOR |
| Affiliation |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
GURUGRAM, HARYANA 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
ashtha.arya@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT Dental College Hospital and Research Institute, Gurugram, Haryana, India Pin code 122505 |
|
|
Primary Sponsor
|
| Name |
SGT UNIVERSITY |
| Address |
SGT Dental College Hospital and Research Institue
Gurugram, Haryana, India Pin code 122505 |
| 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 KHUSHBU |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences
Gurgaon
HARYANA |
9868226062
khushbubarak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT UNIVERSITY ETHICAL COMMITTEE |
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 |
1)Local Anesthetic Agents
2)Cryotherapy |
1. To evaluate the anaesthetic efficacy of 4% articaine in IANB as compared to buccal infiltration techniques.
2. To compare the anaesthetic efficacy of cryotherapy as an adjunct to articaine and determine the best technique that provide maximum success in patients with symptomatic irreversible pulpitis.
|
| Intervention |
Different anesthetic methods |
1. To evaluate the anaesthetic efficacy of 4% articaine in IANB as compared to buccal infiltration techniques.
2. To compare the anaesthetic efficacy of cryotherapy as an adjunct to articaine and determine the best technique that provide maximum success in patients with symptomatic irreversible pulpitis.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
57.00 Year(s) |
| Gender |
Both |
| Details |
1)Mature permanent mandibular molars diagnosed with symptomatic irreversible pulpitis.
2)Teeth having sufficient tooth structure for adequate isolation.
3)No history of previous endodontic therapy.
4)Patients with no relevant medical history. |
|
| ExclusionCriteria |
| Details |
1)Immunocompromised patients, pregnant and lactating females.
2)Periodontally compromised teeth.
3)Patients with pulp necrosis, periapical radiolucency, sinus tract, and periapical abscess.
4)Allergy, sensitivity or contraindications to articaine.
5)Patients who had taken analgesics within 12 hours before root canal therapy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the anaesthetic efficacy of 4% articaine in IANB as compared to buccal infiltration techniques. |
Baseline, 30mins and 1hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the anaesthetic efficacy of cryotherapy as an adjunct to articaine & determine the best technique that provide maximum success in patients with symptomatic irreversible pulpitis. |
Baseline, 30mins & 1hour |
|
|
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)
|
01/12/2024 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
AIM:
Evaluation of anaesthetic efficacy of cryotherapy application as an adjunct to
articaine in patients with symptomatic irreversible pulpitis.OBJECTIVE: To
evaluate the anaesthetic efficacy of 4% articaine in IANB as compared to buccal
infiltration techniques. To compare the anaesthetic efficacy of cryotherapy as
an adjunct to articaine and determine the best technique that provide maximum
success in patients with symptomatic irreversible pulpitis.MATERIALS AND METHOD
The proposed study will be conducted at Department of Conservative Dentistry
and Endodontics, Faculty of Dental Sciences, SGT University, Gurugram, Haryana
after the approval from the ethical committee.PATIENT SELECTION: GROUP 1 (n 15)
Inferior alveolar nerve block with articaine. GROUP 2 (n 15) Inferior alveolar
nerve block with articaine plus application of ice stick in the pulp chamber. GROUP
3 (n 15) Buccal infiltration with articaine plus application of ice stick in
the pulp chamber.There is paucity of clinical studies in evaluating the
anaesthetic efficacy of cryotherapy application as an adjunct to articaine in
patients with symptomatic irreversible pulpitis. Thus, the purpose of current
randomized controlled trial is evaluation of anaesthetic efficacy of
cryotherapy application as an adjunct to articaine in patients with symptomatic
irreversible pulpitis. RESULTS: On going research CONCLUSION: On going research |