| CTRI Number |
CTRI/2024/04/066299 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Prospective Study to Evaluate the Role of Acute Phase Reactants in the Management of Odontogenic Space Infections |
|
Scientific Title of Study
|
A Prospective Study To Evaluate The Role Of Acute Phase Reactants In The Management Of Odontogenic Space Infections |
| Trial Acronym |
APSERAPRMOSI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin Verma |
| Designation |
Head and Professor |
| Affiliation |
Punjab Government Dental College and Hospital, Amritsar |
| Address |
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar.
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar.
Amritsar
PUNJAB
143001
India |
| Phone |
9814164068 |
| Fax |
|
| Email |
nitinvermagdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Verma |
| Designation |
Head and Professor |
| Affiliation |
Punjab Government Dental College and Hospital, Amritsar |
| Address |
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814164068 |
| Fax |
|
| Email |
nitinvermagdc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Verma |
| Designation |
Head and Professor |
| Affiliation |
Punjab Government Dental College and Hospital, Amritsar |
| Address |
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar
Room no 3, Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814164068 |
| Fax |
|
| Email |
nitinvermagdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery,Punjab Government Dental College and Hospital, Amritsar |
|
|
Primary Sponsor
|
| Name |
Punjab Government Dental College and Hospital,Amritsar |
| Address |
Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road ,Amritsar |
| Type of Sponsor |
Government 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 |
| Dr Damini Singh |
Punjab Government Dental College and Hospital |
Room no 3, Department of Oral and Maxillofacial surgery, Punjab Government Dental College and Hospital, SSSS Chownk , Majitha Road ,Amritsar
Amritsar
PUNJAB |
9781234650
damininagah99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Punjab Government Dental College and Hospital , Amritsar(BFUHS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
preoperative and postoperative values of serum procalcitonin , ESR , CRP ,TLC |
preoperative and postoperative values of serum procalcitonin , ESR , CRP ,TLC after incision and drainage and antibiotic prophylaxis |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients, aged 19 years or older with fascial space infection of odontogenic origin.
2. Any carious/ periodontally compromised teeth which can be considered as foci of infection.
3. Patients falling in ASA class 1, 2 and 3.
4. Patients willing for procedure and subsequent follow ups.
|
|
| ExclusionCriteria |
| Details |
1. Patients falling in ASA class 4 and 5.
2. Patents who are on oral / I.V antibiotic therapy prior to blood investigations.
3. Patients on long term steroids.
4. Patients who are pregnant.
5. Patients with facial space infection of non odontogenic origin.
6. Patients previously radiated maxillofacial region.
7. Patents who are not willing to give consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient’s CBC, ESR, CRP and serum procalcitonin levels will be evaluated on 1st day followed by incision and drainage and /or extraction of offending tooth. Patient’s post operative levels of CBC, ESR, CRP and serum procalcitonin will be evaluated on the 5th day after intervention |
1st day , 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| other postoperative parameters include 1.) Maximum mouth opening.2.) Swelling 3.) Pain |
patient will be followed up on first, third, fifth, seventh and tenth post-operative day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
10/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
Maxillofacial infections are life-threatening diseases commonly caused by
odontogenic origin. Facial space infections of odontogenic origin have latent spaces
that are anatomically connected to each other, thus allowing
the infections to spread
which can progress to sepsis. Acute phase reactants (APR) are inflammation
markers that exhibit significant changes
Maxillofacial in serum concentration during inflammation. CRP (C-Reactive
protein), ESR (Erythrocyte Sedimentation Rate, TLC (Total Leucocyte Count )and
serum procalcitonin are important mediators reduced in the liver during acute
and chronic inflammatory states. This purpose of this study is to evaluate the
values of acute phase reactants such
as Erythrocyte Sedimentation Rate (ESR), TLC ,CRP (C-Reactive protein)
and serum procalcitonin in patients having
odontogenic space infections both preoperatively and postoperatively . |