| CTRI Number |
CTRI/2024/05/067643 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect on Interleukin-6 levels in saliva of the diabetic patients having periapical lesion |
|
Scientific Title of Study
|
Evaluation of Salivary Interleukin-6 levels in Diabetic patients with periapical lesion-An In Vivo 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 Rashi Bansal |
| Designation |
MDS(Postgraduate) |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no 7, Department of Conservative Dentistry and Endodontics,
ITS Dental College Hospital And Research Centre,
47, Knowledge Park III,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9679469452 |
| Fax |
|
| Email |
rashibansal854@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Kumari |
| Designation |
Professor |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no 7, Department of Conservative Dentistry and Endodontics,
ITS Dental College Hospital And Research Centre,
47, Knowledge Park III,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9811056881 |
| Fax |
|
| Email |
dr.manjukumari.dntl.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashi Bansal |
| Designation |
MDS(Postgraduate) |
| Affiliation |
ITS Dental College Hospital And Research Centre, Greater Noida |
| Address |
Room no 7, Department of Conservative Dentistry and Endodontics,
ITS Dental College Hospital And Research Centre,
47, Knowledge Park III,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9679469452 |
| Fax |
|
| Email |
rashibansal854@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 7, Department of Conservative Dentistry and Endodontics, ITS Dental College Hospital and Research Centre,47, Knowledge park III, Greater noida- 201308,Uttar Pradesh , India |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital And Research Centre |
| Address |
Room no 7 Department of Conservative Dentistry and Endodontics
ITS Dental College
Greater Noida |
| 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 Rashi Bansal |
ITS Dental College Hospital and Research Centre, Greater Noida |
Room no 7, Department of Conservative and Endodontics,
ITS Dental College and Research Centre,
47,Knowledge Park III,
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9679469452
rashibansal854@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS Dental College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
healthy patients with no periapical lesion |
This group will evaluate the salivary interleukin-6 levels through ELISA in 15 healthy patients with vital (healthy) tooth indicated for intentional root canal treatment before root canal treatment and after BMP, on the day of obturation. |
| Comparator Agent |
Healthy patients with periapical lesion |
This group will evaluate the salivary interleukin-6 levels through ELISA in 15 healthy patients having periapical radiolucency measuring not more than 4mm diameter before root canal treatment and after BMP, on the day of obturation. |
| Intervention |
Type 2 Diabetes mellitus with no periapical lesion |
This group will evaluate the salivary interleukin-6 levels through ELISA in 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) without periapical lesion before root canal treatment and after BMP, on the day of obturation. |
| Intervention |
Type 2 Diabetes mellitus with periapical lesion |
This group will evaluate the salivary interleukin- 6 levels through ELISA in 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) with periapical lesion measuring not more than 4mm diameter before root canal treatment and after BMP,on the day of obturation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender and age between 20-65 years
2. Patients with type 2 diabetes mellitus with RBS levels not more than 160 mg/dl
3. Patient with symptomatic/ asymptomatic irreversible pulpitis
4. Patients having healthy periodontal status
5. Patients consenting to participate in the study.
6. Patients with caries will be restored prior to the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having other systemic diseases such as hypertension, cancer, Obesity, heart diseases, Alzheimer’s disease, pregnant women
2. Any use of medicaments such as anti-inflammatory or antibiotics in past 3 months.
3. Periapical lesion more than 4mm
4.Teeth with periodontal infections
5. Patients having habits like smoking, drinking alcohol etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the levels of IL-6 before and after the root canal treatment in healthy patients
2. To evaluate and compare the levels of IL-6 before and after the root canal treatment in diabetic patients
|
Baseline(on the day of onset of trial) and after 1 week(post operative) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the effect on IL-6 due to endodontic lesions |
Baseline(on the day of onset of trial) & after 1 week(post operative) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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 study will be done to evaluate the interleukin- 6 levels in the diabetic patients with periapical lesion. The forthcoming in vivo study will be carried out within the Department of Conservative Dentistry and Endodontics at ITS Dental College and Research Centre in Greater Noida, Uttar Pradesh. A total number of 60 patients including healthy and type 2 diabetes mellitus patients of age 20-65 years reporting to the OPD of Department of Conservative Dentistry will be selected as per the inclusion and exclusion criteria. Medical and dental history will be recorded for patients reporting to the Department of Conservative and Endodontics and patients will be selected according to the inclusion criteria in the study. Included patients will be informed about the study and explained in detail about the procedure of the study and requirement for the same. A preoperative radiograph will be taken to assess the size of Periapical radiolucency which should be less than 4mm. RBS levels will be checked using glucometer when the patient will report in the OPD. OPG will be done to evaluate the periodontal health.They will be divided into 4 groups. Group A- 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) with periapical lesion measuring not more than 4mm Group B- 15 patients with type 2 diabetes mellitus (patients who are on oral medications with fasting plasma less than 100 mg/dl) without periapical lesion. Group C – 15 healthy patients having periapical radiolucency measuring not more than 4mm diameter Group C - 15 healthy patients with vital (healthy) tooth indicated for intentional root canal treatment. Saliva will be collected before the treatment. Saliva will be collected after BMP, on the day of obturation. Saliva will be tested through ELISA for the interleukin 6 levels. |