| CTRI Number |
CTRI/2025/08/093243 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Testing blood markers to check gum health in smokers and non-smokers. |
|
Scientific Title of Study
|
Cell free DNA and its receptor TLR9: a possible marker for periodontal disease status in smokers and non-smokers. |
| 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 Sruthy Sudir |
| Designation |
Postgraduate student |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre, 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
9535520386 |
| Fax |
|
| Email |
SRUTHYSUDIR@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Associate Professor |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre, 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
7259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeela Guru |
| Designation |
Associate Professor |
| Affiliation |
Vydehi Institute of Dental Sciences and Research Centre |
| Address |
Department of Periodontics, Room number 6,Vydehi Institute of Dental Sciences and Research Centre, 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA
560066
India |
| Phone |
7259665551 |
| Fax |
|
| Email |
sanjeelaguru@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sruthy Sudir |
| Address |
Department of Periodontics, Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka |
| Type of Sponsor |
Other [Individual sponsor] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sruthy Sudir |
Department of Periodontics, Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sruthy Sudir |
Room No.6 Department of Periodontics, Vydehi Institute of Dental Sciences and Research Centre |
Department of Periodontics, Vydehi Institute of Dental Sciences and Research Centre 82, Nallurahalli Main Rd, near BMTC 18th Depot, Whitefield, Bengaluru, Karnataka
Bangalore
KARNATAKA |
9535520386
SRUTHYSUDIR@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institute of Dental Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smokers with Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collection of GCF samples |
Collection of GCF samples from patients with periodontitis and smokers with periodontitis and comparison of the cfDNA levels. |
| Comparator Agent |
Smoking |
Healthy group compared with patients having periodontitis and smokers with periodotitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Group 1:Periodontal health with intact periodontium (healthy)
Group 2:Subjects with Stage II-IV generalized periodontitis.
Group 3: Subjects with the habit of smoking nicotine cigarettes with periodontitis
|
|
| ExclusionCriteria |
| Details |
Patients with any systemic disease.
Former smokers.
People using other forms of smoking along with cigarettes.
Patients undergoing orthodontic treatment.
Pregnancy or lactation.
Patients with history of periodontal therapy within past 3 months.
Patients with history of antibiotic intake within past 3 months.
Patients with history of anti-inflammatory drug therapy within 3 months.
Patients with any intra oral lesions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in salivary or gingival crevicular fluid (GCF) levels of cell-free DNA and TLR9 expression between smokers, non-smokers, and healthy controls, and their correlation with periodontal disease severity. |
Difference in salivary or gingival crevicular fluid (GCF) levels of cell-free DNA and TLR9 expression between smokers, non-smokers, and healthy controls, and their correlation with periodontal disease severity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in periodontal clinical parameters (PPD, CAL, BOP, PI, GI) after therapy.
Correlation between cfDNA/TLR9 levels and disease severity.
Differences in cfDNA/TLR9 changes between smokers and non-smokers over time.
Diagnostic accuracy of cfDNA/TLR9 in distinguishing disease status and predicting treatment response. |
Difference in salivary or gingival crevicular fluid (GCF) levels of cell-free DNA and TLR9 expression between smokers, non-smokers, and healthy controls, and their correlation with periodontal disease severity. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2025 |
| 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
|
Informed consent was obtained from the
patients who are willing to participate in the study. GCF samples will
collected from all subjects followed by the recording of clinical parameters at
baseline. Patients in group 2 and 3 will further receive standard periodontal
therapy as deemed necessary after the baseline recordings and GCF collection. |