| CTRI Number |
CTRI/2025/03/083629 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone Healing Treatment and Inflammation Levels in Smokers vs. Non-Smokers"
|
|
Scientific Title of Study
|
Clinical Evaluation OF efficacy OF BOVINE DERIVED Xenograft In Treatment of Infrabony Defect along with Level OF CHEMOKINE EOTAXIN-1 IN SMOKER VS NON-SMOKER“ A CLINCO BIOCHEMICAL 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 Rebecca Chowdhry |
| Designation |
Reader |
| Affiliation |
ITS DENTAL COLLEGE MURADNAGAR |
| Address |
ITS Dental College Muradnagar NH-24. Uttarpradesh
UTTAR PRADESH
201206
India |
| Phone |
7455036070 |
| Fax |
|
| Email |
dr.rebeccachowdhry@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Gaurav Das |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ITS DENTAL COLLEGE MURADNAGAR |
| Address |
FLAT NO C3 KANCHAN APARTMENTS RAJAT KAMAL PATH
ASSAM
781024
India |
| Phone |
08826214798 |
| Fax |
|
| Email |
gauravdas429@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gaurav Das |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
ITS DENTAL COLLEGE MURADNAGAR |
| Address |
ITS Dental COllege Muradngar
NH-34. Uttar Pradesh- 201206
UTTAR PRADESH
201206
India |
| Phone |
9773727552 |
| Fax |
|
| Email |
gauravdas429@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College Muradnagar
NH-34 Uttar Pradesh- 201206 |
|
|
Primary Sponsor
|
| Name |
GAURAV DAS |
| Address |
ITS DENTAL COLLEGE MURADNAGAR
UTTAR PRADESH 201206 |
| 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 |
| GAURAV DAS |
ITS DENTAL COLLEGE |
MURADNAGAR GHAZIABAD 201206
Ghaziabad
UTTAR PRADESH |
9773727552
gauravdas429@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S INSTITUTIONAL ETHICS COMMITTEE (IIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOSS Xenograft In Smoker AND Non Smoker Group. |
BIOSS Xenograft In Smoker AND Non Smoker Group |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects clinically diagnosed with intrabony defects of more than 3mm depth.
2) Radiographic evidence of defect
3) Moderate smoker (10-19 cigarettes/day)
4) Patient willing to comply to treatment protocol |
|
| ExclusionCriteria |
| Details |
1) Pregnancy and Lactation
2) Patients who have taken antibiotics in the previous 3 months
3) Failure to provide consent
4) Patients not maintaining oral hygiene |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pocket Probing Depth, Relative Attachment Level, Linear bone growth, Alveolar Crest Height, Defect Depth, Chemokine Eotaxin-1 level and Absolute eosinophilic count. |
Baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index and Plaque Index |
Baseline, 3months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
14/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 polymicrobial infection that leads to progressive damage to tooth-supporting structures, causing tooth loss. Host response plays a key role in connective tissue and bone breakdown. Cigarette smoking is a significant risk factor for periodontitis, exacerbating inflammation and disease progression. Intrabony defects, which can result from periodontitis, are site-specific risk factors for further tissue loss and bacterial colonization. Regenerative periodontal therapies, such as bone grafting and guided tissue regeneration, aim to restore lost tooth-supporting structures. Bio-Oss® is a bovine-derived xenograft that has shown promise in promoting bone ingrowth and repairing defects. Smoking negatively impacts periodontal health and treatment outcomes, with smokers showing poorer responses to treatments. Chemokine CCL11 (Eotaxin-1), involved in inflammatory bone resorption and osteoclast migration, may play a crucial role in periodontitis progression. This study aims to evaluate the effectiveness of Bio-Oss® in treating infrabony defects in smokers versus non-smokers, along with assessing the role of Eotaxin-1 levels in these patients before and after treatment. |