| CTRI Number |
CTRI/2025/05/086091 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF VARIOUS ANALGESICS IN POST OPERATIVE PAIN MANAGEMENT AFTER IMPLANT PLACEMENT A RANDOMIZED CLINICAL TRIAL |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF VARIOUS ANALGESICS IN POST OPERATIVE PAIN MANAGEMENT AFTER IMPLANT PLACEMENT A RANDOMIZED CLINICAL 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 ALOK CHAUHAN |
| Designation |
MDS POSTGRADUATE |
| Affiliation |
INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 228 DEPARMENT OF PERIODONTOLOGY AND IMPLANTOLOGY INSTITUTE OF DENTAL SCIENCES PILIBHIT BYE PAAS ROAD SURESH SHARMA NAGAR BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8979369983 |
| Fax |
|
| Email |
alok7chauhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ALOK CHAUHAN |
| Designation |
MDS POSTGRADUATE |
| Affiliation |
INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 228 DEPARMENT OF PERIODONTOLOGY AND IMPLANTOLOGY INSTITUTE OF DENTAL SCIENCES PILIBHIT BYE PAAS ROAD SURESH SHARMA NAGAR BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8979369983 |
| Fax |
|
| Email |
alok7chauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANVI CHANDRA AGARWAL |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF DENTAL SCIENCES |
| Address |
ROOM NO 228 DEPARMENT OF PERIODONTOLOGY AND IMPLANTOLOGY INSTITUTE OF DENTAL SCIENCES PILIBHIT BYE PAAS ROAD SURESH SHARMA NAGAR BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9457540800 |
| Fax |
|
| Email |
agarwalmanvi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institue of dental sciences and hospital bareilly |
|
|
Primary Sponsor
|
| Name |
ALOK CHAUHAN |
| Address |
Room no 228 Department of periodontology and implantology Institute of dental sciences Pilibhit bypass road bareilly |
| Type of Sponsor |
Private medical college |
|
|
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 |
| ALOK CHAUHAN |
INSTITUTE OF DENTAL SCIENCES |
ROOM NO 223 DEPARTMENT OF PERIODONTOLOGY AND IMPLANTOLOGY INSTITUTE OF DENTAL SCIENCES PILIBHIT BYPASS ROAD SURESH SHARMA NAGAR
Bareilly
UTTAR PRADESH |
8979369983
alok7chauhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Dental Sciences, Bareilly, UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M952||Other acquired deformity of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
55.00 Day(s) |
| Gender |
Both |
| Details |
Subjects requiring single implant placement in either jaw (delayed or immediate).
Systemically healthy individuals.
Patients ranging from 25 - 55 years of age. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females.
Patients on anti-psychotics or antidepressants.
Immunologically compromised patients.
Patients consuming alcohol. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate and compare the effectiveness of Aceclofenac , Acetaminophen and Tramadol combination versus Aceclofenac alone. |
evaluate and compare the effectiveness of Aceclofenac , Acetaminophen and Tramadol combination versus Aceclofenac alone. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="0"
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
|
Taking into account the conflicting results of various
stand alone analgesics for the
management of post operative pain after implant therapy, combination of
analgesics will be used and compared to a single drug use, moreover, there is
paucity of research on this aspect and it would be a beneficial outcome if
supported with evidence. Therefore, this study is planned to evaluate and compare
the effectiveness of Aceclofenac and Tramadol combination with Aceclofenac and
Tramadol alone. |