| CTRI Number |
CTRI/2024/06/068425 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Understanding inflammatory markers in gum fluid and their role in gum disease |
|
Scientific Title of Study
|
Association of Interleukin-35 levels in gingival crevicular fluid in periodontal health and disease: A comparative 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 |
Radhika Singh |
| Designation |
Postgraduate Student |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9760613666 |
| Fax |
|
| Email |
radhikasingh26071994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Singh |
| Designation |
Reader |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7081222230 |
| Fax |
|
| Email |
akkisingh014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Singh |
| Designation |
Reader |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7081222230 |
| Fax |
|
| Email |
akkisingh014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh India 243006 |
|
|
Primary Sponsor
|
| Name |
Radhika Singh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh India 243006 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Akanksha Singh |
Institute of dental sciences pilibhit byepaas road Bareilly Uttar pradesh India 243006 |
Room no 228 Department of Periodontology and Implantology Institute of Dental sciences pilibhit byepass road Bareilly Uttar pradesh 243006
Bareilly
UTTAR PRADESH |
7081222230
akkisingh014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,IDS,BAREILLY,UP |
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 |
| Comparator Agent |
Interleukin 35 |
Interleukin 35 is a new anti inflammatory cytokine from family of Interleukin 12 secreted by regulatory T cells It has an inhibitory function on the proliferation of T cell by arresting the G 1 phase of Mitosis cycle in somatic cells Biomarkers are found in Gingival crevicular fluid |
| Intervention |
Non surgical periodontal treatment |
Scaling and root planing with the help of ultrasonic scalers
Total duration 0 days 3 months follow up |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with age group between 25-60 years
2.Diagnosis of periodontal disease that is chronic periodontitis with probing pocket depth greater than 3 mm and Clinical attachment loss greater than 3 mm
3.Gingivitis that is patients showing clinical evidence of gingival inflammation but no CAL PPD of less than 3 mm and Gingival index score greater than 1
4. Periodontally healthy individuals that is showing no sign of clinical inflammation and periodontitis |
|
| ExclusionCriteria |
| Details |
1.Systemic illnesses affecting periodontal disease.
2.Alcohol and tobacco consumers (in whatever form).
3.Females- pregnant or nursing.
4.Patient who has undergone periodontal treatment in six months back. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF NON-SURGICAL PERIODONTAL THERAPY ON IL-35 INCREASED OR DECREASED IN CHRONIC PERIODONTITIS |
0 DAYS AND 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the possibility of using IL-35 as a biomarker for periodontal disease activity. |
3 MONTHS 0 DAYS |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
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
Modification(s)
|
Periodontitis is a multifaceted disease involving soft and hard tissues of the oral cavity. The sole reason of periodontitis is the interaction between host tissue and bacteria attached to the teeth forming a biofilm.This study will be conducted to estimate and compare the levels of Interleukin-35 in Gingival crevicular fluid among gingivitis and chronic periodontitis patients before and after non-surgical periodontal therapy and to explore the possibility of using IL-35 as a biomarker for periodontal disease activity. |