| CTRI Number |
CTRI/2026/04/108240 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of blood based systemic inflammatory index in patients with gum disease |
|
Scientific Title of Study
|
Assessment of the aggregate index of systemic inflammation,
systemic immune inflammation index and C-Reactive protein
levels in patients with Chronic Periodontitis: An Observational
study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSakshi Sanjay Awaghad |
| Designation |
Post Graduate student |
| Affiliation |
ACPM Dental College and Hospital, Dhule |
| Address |
Department of Periodontology and Oral Implantology, Room no.3, ACPM College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Department of Periodontology and Oral Implantology, Room no.3, ACPM Dental College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
7261947903 |
| Fax |
|
| Email |
awaghadsakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Waghmare |
| Designation |
Head of the Department |
| Affiliation |
ACPM Dental College and Hospital, Dhule |
| Address |
Department of Periodontology and Oral Implantology, Room no.3, ACPM Dental College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Department of Periodontology and Oral Implantology, Room no.3, ACPM Dental College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
9423918900 |
| Fax |
|
| Email |
dralkawaghmare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alka Waghmare |
| Designation |
Head of the Department |
| Affiliation |
ACPM Dental College and Hospital, Dhule |
| Address |
Department of Periodontology and Oral Implantology, Room no.3, ACPM Dental College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Department of Periodontology and Oral Implantology, Room no.3, ACPM Dental College and Hospital, Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik.
Dhule
Maharashtra
424001
India
Dhule
MAHARASHTRA
424001
India |
| Phone |
9423918900 |
| Fax |
|
| Email |
dralkawaghmare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Sakshi Sanjay Awaghad |
| Address |
Department of Periodontology and Oral Implantology, Room no. 3, ACPM Dental College and Hospital,Sakri road, Dhule, tak. Dist. Dhule, Affilated to MUHS Nashik |
| 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 |
| DR SAKSHI AWAGHAD |
JAWAHAR MEDICAL FOUNDATIONS ANNASAHEB CHUDAMAN PATIL MEMORIAL DENTAL COLLEGE |
DEPARTMENT OF PERIODONTOLOGY AND ORAL IMPLANTOLOGY,ROOM NO.3, JAWAHAR MEDICAL FOUNDATIONS ANNASAHEB CHUDAMAN PATIL MEMOTRIAL DENTAL COLLEGE, SAKRI ROAD, DHULE, 424001
Dhule
MAHARASHTRA |
7261947903
awaghadsakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JMFs ACPMDC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Venous blood |
Venous blood will be collected by venepuncture from the antecubital vein of the left forearm under aseptic conditions with the help of 24-gauge needle of 5ml syringe and will be transferred to the vial.
Blood samples will be sent for biochemical analysis for, Neutrophil count, Platelet count, Lymphocytes count and Monocyte count.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Within the age group of 30 to 60 years.
2. Patients having at least 20 teeth (not including third molars and teeth with orthodontic appliances, bridges, crowns, or implants).
3. At least more or equal to 2 teeth with one or more sites with probing depth of at least more or equal to 4mm .
4. At least more or equal to 2 teeth with one or more sites with interdental clinical attachment loss (CAL) more or equal to of 3-4 mm.
5. Patients who are willing to participate in the study and given their written consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients having Systemic illnesses (i.e. cancer, human immunodeficiency syndrome, hepatic diseases, bone metabolic diseases, cardiovascular diseases, lung diseases, malignancies or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
2.Chronic alcoholic patients.
3.Pregnant or lactating women.
4.History of periodontal therapy within the last 6 months.
5.Patients who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
)To assess Systemic Immune-Inflammation Index (SII),
2)To assess Aggregate Index of Systemic Inflammation (AISI) and
3)To assess C-reactive protein levels
4)To assess and compare Systemic Immune Inflammation Index,
Aggregate Index of Systemic Inflammation and C-reactive protein
levels in chronic periodontitis patients. |
NIL- one point study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
21/04/2026 |
| 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="4"
Days="2" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [awaghadsakshi@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a randomized clinical trail. The primary objective is To assess and compare Systemic Immune Inflammation Index, Aggregate Index of Systemic Inflammation and C-reactive protein levels in chronic periodontitis patients. The following parameters will recorded such as CPI index and clinical attachment level. |