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Clinical Trials/CTRI/2025/03/083629
CTRI/2025/03/083629
Not yet recruiting
Phase 3

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.

GAURAV DAS1 site in 1 country32 target enrollmentStarted: April 14, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
GAURAV DAS
Enrollment
32
Locations
1
Primary Endpoint
Pocket Probing Depth, Relative Attachment Level, Linear bone growth, Alveolar Crest Height, Defect Depth, Chemokine Eotaxin-1 level and Absolute eosinophilic count.

Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects clinically diagnosed with intrabony defects of more than 3mm depth.
  • Radiographic evidence of defect 3) Moderate smoker (10-19 cigarettes/day) 4) Patient willing to comply to treatment protocol.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pocket Probing Depth, Relative Attachment Level, Linear bone growth, Alveolar Crest Height, Defect Depth, Chemokine Eotaxin-1 level and Absolute eosinophilic count.

Time Frame: Baseline, 3 months and 6 months.

Secondary Outcomes

  • Gingival Index and Plaque Index(Baseline, 3months and 6 months.)

Investigators

Sponsor
GAURAV DAS
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Rebecca Chowdhry

ITS DENTAL COLLEGE MURADNAGAR

Study Sites (1)

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