| CTRI Number |
CTRI/2024/05/066734 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
8-Isoprostane biomarker levels in patients with high blood pressure and pulp necrosis with symptomatic apical periodontitis |
|
Scientific Title of Study
|
Gingival Crevicular Fluid Levels Of 8-Isoprostane In Hypertensive Patients Diagnosed With Pulp Necrosis And Symptomatic Apical Periodontitis:Cross Sectional 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 |
Chahat Singhal |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room number QS 27,Department Of Conservative Dentistry And Endodontics, Manav Rachna Dental College, Sector 43 Delhi Surajkund Badkhal Road ,Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971818427 |
| Fax |
|
| Email |
chahat0397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Jala |
| Designation |
Reader |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room No QS 27 ,Department Of Conservative Dentistry And Endodontics, Manav Rachna Dental College, Sector 43 Delhi Surajkund Badkhal Road ,Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
7042643666 |
| Fax |
|
| Email |
sucheta.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Chahat Singhal |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Room number QS 27 ,Department Of Conservative Dentistry And Endodontics, Manav Rachna Dental College, Sector 43 Delhi Surajkund Badkhal Road ,Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971818427 |
| Fax |
|
| Email |
chahat0397@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chahat Singhal (Self Funded)
Room No QS 27,Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Sector 43 Delhi Surajkund Badkhal Road, Faridabad, Haryana 121004
|
|
|
Primary Sponsor
|
| Name |
Chahat Singhal |
| Address |
Room No QS 27 ,Department Of Conservative Dentistry And Endodontics, Manav Rachna Dental College, Sector 43 Delhi Surajkund Badkhal Road,Faridabad,Haryana-121004 |
| 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 Chahat Singhal |
Manav Rachna Dental College |
Room number QS 27,Department Of Conservative Dentistry and Endodontics, Manav Rachna Dental College Sector 43 Delhi Surajkund Badkhal Road
Faridabad
HARYANA |
9971818427
chahat0397@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: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with relevant history of hypertension blood pressure in range of 140 to 159 mm Hg Systolic blood pressure and 90 to 99 mm Hg diastolic blood pressure i.e. Hypertension Grade I
2.Patients on medications for hypertension
3.Patients diagnosed with Pulp necrosis and Symptomatic Apical periodontitis according to AAE guidelines
4.Patients with OHI index of 0 and Russells Periodontal index not more than 0.9 |
|
| ExclusionCriteria |
| Details |
1.Patients having negative response to percussion testing
2.Patients with chronic periodontitis
3.Patients with any other underlying systemic diseases
4.Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be increased levels of 8 Isoprostane in hypertensive patients diagnosed with pulp necrosis and symptomatic apical periodontitis as compared to patients diagnosed with hypertension measured only at one point of time ie at time of sample collection. |
The levels of Biomarker 8-Isoprostane in gingival crevicular fluid will be measured only at time of Sample Collection.The estimation will be done at the time of sample collection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/05/2024 |
| 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="15" |
|
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
|
In the present study attempt will be made to estimate levels of 8 -Isoprostane in gingival crevicular fluid samples in hypertensive patients diagnosed with pulp necrosis and Symptomatic apical peridontitis.The study is based on the null hypothesis that there will be no difference in baseline levels of 8- isoprostane in gingival crevicular fluid samples of patients diagnosed with hypertension as compared to patients diagnosed with hypertension and pulp necrosis with symptomatic apical periodontitis.The study samples will be recruited into 4 groups with total sample size of 200 with 50 samples in each group-Group I-Healthy controls with no evidence of caries and systemic disease Group II-Patients diagnosed with hypertension Group III-Patients diagnosed with Pulp necrosis and Symptomatic Apical Periodontitis without systemic diseases and Group IV-Hypertensive Patients diagnosed with Pulp necrosis and Symptomatic Apical periodontitis .Gingival crevicular samples will be collected and 8-Isoprostane levels will be estimated using Sandwich ELISA tests. |