| CTRI Number |
CTRI/2024/04/065243 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of the analgesic effectiveness of oral and topical ketoprofen administration for postoperative pain management following Periodontal flap surgery. |
|
Scientific Title of Study
|
Comparision of Analgesic Efficacy of Ketoprofen delivered through Transdermal and oral routes in Post operative Pain management following Periodontal Flap Surgery. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADE RAMESH |
| Designation |
PG STUDENT |
| Affiliation |
|
| Address |
Room no 8,
Second floor
Department of periodontics
Sibar institute of Dental sciences, Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
7093123001 |
| Fax |
|
| Email |
dr.aderamesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A Chaitanya |
| Designation |
Reader |
| Affiliation |
|
| Address |
Room no 8,
Second floor
Department of periodontics
Sibar institute of Dental sciences, Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8885267278 |
| Fax |
|
| Email |
chaitanyaadurty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A Chaitanya |
| Designation |
Reader |
| Affiliation |
|
| Address |
Room no 8,
Second floor
Department of periodontics
Sibar institute of Dental sciences, Takkellapadu
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8885267278 |
| Fax |
|
| Email |
chaitanyaadurty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of periodontics
Sibar institute of Dental sciences, Takkellapadu |
|
|
Primary Sponsor
|
| Name |
ade.ramesh |
| Address |
ROOM NO. 8 , SECOND FLOOR, SIBAR INSTITUTE OF DENTAL
SCIENCES, TAKKELLAPADU, GUNTUR |
| 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 |
| Aderamesh |
Sibar institute of dental sciences |
Room no:8
sibar institute of dental sciences
Guntur
ANDHRA PRADESH |
7093123001
dr.aderamesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SIBAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
50 mg of oral ketoprofen |
Following the flap surgery on one quadrant, 50 mg of oral ketoprofen, twice daily for 3 days, will be prescribed |
| Intervention |
20 mg ketoprofen transdermal patch |
Following the flap surgery on one quadrant,a 20 mg ketoprofen transdermal patch (ketoplast) will be placed once daily for 3 days. The transdermal patch would be administered 1 h after flap surgery. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) apparently healthy individuals.
2)patient who are giving informed consent.
3)age group of 25-55 years
4)patient with chronic periodontis. |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of allergy to propionic
acid derivatives.
2. Subjects under chronic treatment with NSAIDs
within 1 month.
3. Pregnancy and lactating woman.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the analgesic efficacy of ketoprofen administered through oral and transdermal routes following flap surgery.
|
24, 48, and 72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the analgesic efficacy of ketoprofen administered through oral & transdermal routes following flap surgery. |
24, 48, & 72hrs |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
03/05/2024 |
| 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="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A total of 10 apparently healthy subjects with chronic periodontitis will be selected into the study according to the inclusion and exclusion criteria. Following the flap surgery on one quadrant, 50 mg of oral ketoprofen, twice daily for 3 days, will be prescribed. When the same patient returned for the flap surgery on the contralateral side, a 20 mg ketoprofen transdermal patch (ketoplast) will be placed once daily for 3 days.Patients will be asked verbally to assign a score for pain intensity at , 24, 48, and 72hrs postoperatively. |