| CTRI Number |
CTRI/2025/02/080538 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"How Gum Disease Treatment Affects Inflammation in Diabetic and Non-Diabetic Patients" |
|
Scientific Title of Study
|
Effect of Non-surgical periodontal treatment (NSPT) on the IL-20 levels in Periodontitis patients with and without Diabetes Mellitus (Type 2) : A Clinico-Biochemical 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 |
Dr Manisha Kumari |
| Designation |
2nd year Post graduate |
| Affiliation |
Government Dental College, Raipur C.G |
| Address |
Room no.12 , 3rd Floor , Department of Periodontics, Government Dental College , Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8168649948 |
| Fax |
|
| Email |
whymanisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VINEETA GUPTA |
| Designation |
PROFESSOR & HEAD |
| Affiliation |
Government Dental College, Raipur C.G |
| Address |
Room no.12 , 3rd Floor , Department of Periodontics, Government Dental College , Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8168649948 |
| Fax |
|
| Email |
vinleo76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Kumari |
| Designation |
2nd year Post graduate |
| Affiliation |
Government Dental College, Raipur C.G |
| Address |
Room no.12 , 3rd Floor , Department of Periodontics, Government Dental College , Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492001
India |
| Phone |
8168649948 |
| Fax |
|
| Email |
whymanisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College , Raipur, Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Kumari |
| Address |
Room no. 12 , 3rd floor , Dept of Periodontics, Government Dental College, Rajbandha Maidan
Raipur(C.G)
Pincode - 492001 |
| Type of Sponsor |
Other [Dr Manisha Kumari] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Manisha Kumari |
oom no. 12 , 3rd floor , Dept of Periodontics, Government Dental College, Rajbandha Maidan
Raipur(C.G)
Pincode - 492001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Kumari |
Government Dental College , Raipur, Chhattisgarh |
Room no.12 , 3rd floor , Dept of Periodontics, Government Dental College, Rajbandha Maidan
Raipur(C.G)
Pincode - 492001
Raipur
CHHATTISGARH |
8168649948
whymanisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-Surgical Periodontal Treatment (NSPT) |
Non-Surgical Periodontal Treatment (NSPT) typically involves scaling and root planing (SRP) in diabetic patients to remove plaque and calculus from the tooth surfaces, followed by sample collection |
| Comparator Agent |
The comparator could be a control group that receive NSPT but do not have diabetes |
The comparison will be between the two groups:
Group 1: Periodontitis patients with Type 2 Diabetes Mellitus (DM)
Group 2: Periodontitis patients without Diabetes Mellitus (Non-DM)
So, the comparison is about the effect of NSPT on IL-20 levels in these two groups, rather than comparing different treatments. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Both men and women of 35 to 55 years of age.
2. Presence of at least 20 teeth in the oral cavity.
3. Patients belonging to Chhattisgarh state.
4. Patient willing to undergo periodontal treatment procedure. |
|
| ExclusionCriteria |
| Details |
1. Participants with any known systemic disease other than diabetes mellitus (type 2).
2. History of smoking or any other form of tobacco use, alcohol intake and drug abuse will be
excluded from the study.
3. Pregnant women or lactating women.
4. History of any form of periodontal treatment in the past 3 months.
5. Patients who used antibiotics or other drugs that affect periodontal status in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will help us to correlate between variation in
Interleukin-20 levels in periodontitis patients with and without diabetic mellitus (type 2). |
Baseline, 6 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome of the study of the study is that non
surgical periodontal treatment (NSPT) will have significant impact on Interleukin-20 levels and
will be well correlated with clinical parameters of periodontal tissue destruction and glycemic
status. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Hypothesis / Research Question –
1.Whether post non-surgical periodontal treatment (NSPT) has any significant impact on
levels of Interleukin-20 in periodontitis patients with and without diabetes mellitus (type 2) ?
2.Whether Interleukin-20 levels can be associated with poor glycemic control and periodontal
disease? |