| CTRI Number |
CTRI/2024/06/068456 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To Compare and evaluate the effect of Nonsurgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2(AIM2) Interferon γ inducible protein(IFI16) Cytokine interleukin(IL18) in Stage III periodontitis with and without Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Comparative evaluation of effect of Non surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon gamma inducible protein (IFI16) Cytokine interleukin (IL18) in Stage III periodontitis with and without Type 2 Diabetes Mellitus an interventional 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 Radhika Rathi |
| Designation |
Post Graduate student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9607428287 |
| Fax |
|
| Email |
rathiradhika549@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna road Nagpur |
| Address |
104 Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills, Hingna road
Nagpur 440019
Maharashtra India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajashri Kolte |
Ranjeet Deshmukh Dental College and Research Centre |
104 Department of Periodontics and Implantology
Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills Hingna road
Nagpur 440019
Maharashtra India
Nagpur
MAHARASHTRA |
9011071468
drrajashrikolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non surgical periodontal therapy |
This interventional study is conducted to compare and evaluate the effect of Non-surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon γ inducible protein (IFI16) Cytokine interleukin (IL 18 ) in Stage III periodontitis with and without Type 2 Diabetes Mellitus .
The study will comprise three group Group I Periodontally healthy patients, blood samples will be obtained at baseline Group II Stage III periodontitis blood samples will be obtained at baseline and 6 weeks after Non Surgical Periodontal Therapy Group III Stage III periodontitis with type 2 diabetes mellitus blood samples will be obtained at baseline and 6 weeks after Non Surgical Periodontal Therapy
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Group I Periodontally healthy patients presence of good oral hygiene with no visual signs of gingival inflammation bleeding on probing(BOP) in less than equal to 1 probing depth(PPD) less than equal to 3 mm
Group II Stage III periodontitis with a minimum of 15 teeth having PPD and clinical attachment level of greater than equal to four mm.
Group III Stage III periodontitis with T2DM PPD and CAL greater than equal to four mm. HbAonec levels in between 6.5 to 8 percentage
|
|
| ExclusionCriteria |
| Details |
1 Patients who have undergone any periodontal therapy in the past 6 months
2 Patients with systemic diseases other than diabetes
3History of any medication including antibiotic treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues
4 Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of NSPT on serum levels of DNA sensing inflammasomes AIM2, IFI-16, cytokine IL18 in Stage III periodontitis with and without T2DM. |
at baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare PPD CAL and PISA in periodontally healthy Stage III periodontitis with and without T2DM patients.
To evaluate and compare the serum levels of DNA sensing inflammasomes AIM2 IFI-16 cytokine IL18 Random blood sugar (RBS) HbA1c in periodontally healthy Stage III periodontitis with and without T2DM patients.
|
at baseline and 6 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
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
|
This interventional study is conducted to compare and evaluate the effect of Non-surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon γ inducible protein (IFI16) Cytokine interleukin (IL 18 ) in Stage III periodontitis with and without Type 2 Diabetes Mellitus . The study will comprise of 90 patients, both males and females, visiting the Department of Periodontology and Implantology divided equally into three group Group I Periodontally healthy patients, presence of good oral hygiene with no visual signs of gingival inflammation bleeding on probing (BOP) in < 1 probing depth(PPD) ≤3 mm Group II Stage III periodontitis with a minimum of 15 teeth having PPD and clinical attachment level (CAL) of ≥4 mm. Group III Stage III periodontitis with T2DM (type 2 diabetes mellitus) PPD and CAL ≥ 4mm. HbA1c levels in between 6.5 % to 8. Informed consent will be taken from the patients who wish to enroll in the study. For Group I blood samples will be obtained at baseline. For Group II and Group III blood samples will be obtained at baseline and 6 weeks after Non Surgical Periodontal Therapy. Comparison and evaluation of the effect of Non-surgical periodontal therapy on serum levels of DNA sensing inflammasomes Absent in Melanoma 2 (AIM2) Interferon γ inducible protein (IFI16) Cytokine interleukin (IL 18 ) in Stage III periodontitis with and without Type 2 Diabetes Mellitus. |