| CTRI Number |
CTRI/2024/01/062104 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Measuring A Disintegrin and Metalloproteinase 17 Marker levels in diabetic and obese patients with periodontitis |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF A DISINTEGRIN AND
METALLOPROTEINASE (ADAM )17 MARKER RESPONSE TO
PERIODONTAL THERAPY IN DIABETES AND OBESE
PATIENTS WITH AND WITHOUT PERIODONTITIS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAMMULA SURYA PRASANNA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Researchcentre |
| Address |
Room no 101, Department of periodontics , PanineeyaMahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JAMMULA SURYA PRASANNA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Researchcentre |
| Address |
Room no 101, Department of periodontics , PanineeyaMahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MUTHYALA SOUMYA SAGAR |
| Designation |
POST GRADUATE |
| Affiliation |
Panineeya Mahavidyalaya Institute of Dental Sciences and Researchcentre |
| Address |
Room no 101, Department of periodontics , PanineeyaMahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad.
Hyderabad
TELANGANA
500060
India |
| Phone |
9705537018 |
| Fax |
|
| Email |
bunnycutie728@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and Research centre,road no 5, kamalanagar Dilsukhnagar, Hyderabad. |
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research centrer |
| Address |
road no 5 kamalanagar Dilsukhnagar Hyderabad. |
| 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 MUTHYALA SOUMYA SAGAR |
Panineeya Mahavidyalaya Institute of Dental Sciences and Researchcentre |
Room no 101, Department of periodontics road no 5 kamalanagar Dilsukhnagar Hyderabad
Hyderabad
TELANGANA |
9705537018
bunnycutie728@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
Group 1(20) – a. diabetics with periodontitis(10)Serum will be collected from the patients at baseline and 3 months after periodontal therapy
b. diabetics without periodontitis(10) |
3 months |
| Intervention |
Group 2 (20)– a. obese patients with peroiodontitis(10)Serum will be collected from the patients at baseline and 3 months after periodontal therapy
b. obese patients without periodontitis(10) |
3 months |
| Intervention |
ï¬Group 3(20)- systemically healthy patients with periodontitis Serum will be collected from the patients at baseline and 3 months after periodontal therapy |
3 months |
| Intervention |
ï¬Group 4 (20)– systemically healthy patients without periodontitis Serum will be collected from the patients at baseline and 3 months after periodontal therapy |
3 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Known diabetic patients(Test group)
patients with BMI values greater than 30(test group)
Individuals with moderate periodontitis( according to 2017 classification)
Patients who have not received periodontal therapy within preceeding
3months.
Patients should have atleast 15 teeth. |
|
| ExclusionCriteria |
| Details |
Presence of any other systemic diseases,genetic diseases,and diseases which
effect periodontitium
Smokers,tobacco chewers and alcholics.
Patients with present and past history of antibiotics and anti inflammatory
drugs in last 3 months.
Patients taking high dose of steroid therapy,radiation therapy or
immunosuppressive therapy and any other medication for systemic diseases.Pregnant and lactating women.
patients undergoing treatment for obesity.
Mentally challenged and un cooperative patients.
Patients not complaint to oral hygiene instuctions and recall
maintenance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Is there any difference in ADAM 17 levels in diabetic and
obese patients
Is there any variation in the ADAM 17 levels before and after
periodontal therapy |
BASE LINE AND 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Is there any variation in the clinical parameters after
periodontal therapy |
BASE LINE AND 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 4 |
|
Date of First Enrollment (India)
|
10/02/2024 |
| 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="0"
Months="3"
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
|
Periodontitis is a local inflammatory process mediating the destruction of periodontium triggered by bacterial insult leading to systemic inflammatory mayhem in the host. It is a prototype of low-grade local infection associated with a moderate systemic inflammatory response. Patients suffering from severe forms of this disease seem to have perturbation of their systemic homeostasis. Another way glycaemic levels and other factors like obesity are also likely to affect the risk of periodontitis.
Epidemiological studies confirm that diabetes is a significant risk factor for periodontitis, and the risk of periodontitis is greater if glycaemic control is poor; people with poorly controlled diabetes, who are also most at risk for the other macrovascular and microvascular complications are at an increased risk of periodontitis and alveolar bone loss
Obesity is a chronic metabolic disease that predisposes to a variety of comorbidities including arterial hypertension, type 2 diabetes mellitus, atherosclerosis, and cardiovascular diseases. Furthermore, obesity has been suggested to be a risk factor for periodontitis.
A Disintegrin And Metalloproteinase (ADAM) are proteins with characteristics of proteases that are regularly found in the membrane of various cell types. It has been reported to cleave tumor growth factor from the membrane. These ADAMs are implicated in a large number of diseases, including diabetes, obesity, etc . Patients with periodontitis may have elevated circulating levels of specific inflammatory markers that can be correlated to the severity of other systemic diseases. These biomarkers of host response can be found in gingival crevicular fluid saliva and serum samples can potentially be used as diagnostic markers. Would like to correlate how ADAM17 will be interlinked with these three conditions. |