| CTRI Number |
CTRI/2024/11/076805 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Evaluation of different transdermal patches and oral painkiller on postoperative pain after root canal treatment in permanent lower molars with irreversible pulpitis |
|
Scientific Title of Study
|
Comparative Evaluation of effect of Various Transdermal Patches and Oral NSAID on Post-Operative Endodontic Pain and Quality of Life - A Randomized Controlled 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 |
Dr A Balaram |
| Designation |
Post-Graduate Student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Room No 14, Staff and PG Quarters, Meenakshi Ammal Dental College and Hospital, Alappakkam Main Road, Maduravoyal
Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
7397549144 |
| Fax |
|
| Email |
balaram.1997@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Sundar |
| Designation |
Associate Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Conservative Dentistry & Endodontics, Room No 9 & 10, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9884511763 |
| Fax |
|
| Email |
sathsundar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Velmurugan |
| Designation |
Head of the Department, Dept of Cons and Endo |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Conservative Dentistry & Endodontics, Room No 9 & 10, Meenakshi Ammal Dental College and Hospital, Alapakkam Main Road, Maduravoyal, Chennai-600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9840164167 |
| Fax |
|
| Email |
velu9911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded Trial, to be conducted in the outpatient department of Department of Conservative Denstistry and Endodontics, Meenakshi Ammal Dental College and Hospital, MAHER, Maduravoyal, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Balaram A |
| Address |
MADCH, Alapakkam, Maduravoyal, Chennai - 600095 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Satish Sundar |
Meenakshi Ammal Dental College and Hospital |
Room No 10, Department of Conservative Dentistry and Endodontics,Meenakshi Ammal Dental College and Hospital, Alapakkam, Maduravoyal, Chennai - 600095
Chennai
TAMIL NADU |
9884511763
sathsundar87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Meenakshi Ammal dental college and Hospital. |
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 |
Ibuprofen Oral 400 mg |
Recommeded dose for post treatment pain is 400 mg BD, but in our trial only a single dose is given for 24 hours. Backup medicine will be provided (Ketorol DT 10 mg only in case of severe pain) |
| Intervention |
Ketoprofen Patch 30mg |
30 mg Of Ketoprofen is given as a patch. One patch for 24 hours of action. No patch administration after 24 hours. Only one patch per patient |
| Comparator Agent |
Placebo Oral Tablet |
Vitamin C 500 mg (for 24 hours duration of action) single dose 1 hour before the procedure is given. No other doses are given. |
| Comparator Agent |
Placebo Patch |
Transdermal Placebo Patch with B Complex Vitamins ,1 patch for 1 patient, for 24 hour duration of action. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically Healthy Individuals with symptomatic irreversible pulpitis and apical periodontitis |
|
| ExclusionCriteria |
| Details |
Systemic Disease
Pregnancy
Lactation
PA Abscess
Drug Allergies
Analgesic intake within last 24 hours |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain relief |
0 hours, 12 hours , 24 hours , 48 hours and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life Assessment |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Post-operative
pain occurs only in 25-40 % patients and can last up to several
days, depending upon peripheral and central mechanisms of hyperalgesia. Pulpal
inflammation and necrosis with the corresponding peri radicular tissue changes
cause the release of inflammatory mediators, including prostaglandins which are
involved in pain medication. The rationale for the pharmacological management
of post-endodontic pain is focused on the reduction of chemical inflammatory
mediators that activate or sensitize peripheral nociceptors and the subsequent
events involved in pain perception. Prostaglandin suppression is important as
it lowers the pain threshold (i.e. allodynia) and sensitizes nociceptors to
other pain mediators. Ibuprofen is the most frequently used NSAID for control
of pain associated with root canal treatment. This trial will compare the efficacy of transdermal and oral analgesic delivery systems in managing post-operative endodontic pain. |