A Smarter Way to Fight Gum Infections: Local Delivery of Antibiotics Using Nanofibres"

Phase 2

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2025/05/086195

Lead Sponsor: UPPUNUTI SWATHI

Brief Summary: Chronic periodontitis is an inflammatory disease caused by harmful bacteria in the mouth, leading to damage of the tissues supporting the teeth. The condition is common, affecting around 51% of adults globally, with severe cases impacting 19% of the population. Plaque buildup is the main cause, with bacteria like Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, and Fusobacterium nucleatum playing a key role. Treatment often includes antibiotics like amoxicillin and metronidazole, but rising antibiotic resistance is a concern. To address this, local drug delivery using nanotechnology has been explored, providing controlled release of antibiotics directly into the affected areas. This method can reduce side effects, improve patient compliance, and enhance treatment effectiveness. The combination of amoxicillin and metronidazole in nanofibers offers a promising solution to combat periodontitis and reduce antibiotic resistance, though more research is needed, especially in the Indian population.

AIM AND OBJECTIVE OF THE STUDY: - The purpose of this study is to evaluate the efficacy of local delivery of amoxicillin and metronidazole nanofibers as an adjunct to SRP have better clinical and microbiological out come when compared to SRP alone in treatment of stage II periodontitis patients

CLINICALPARAMETERS will be assessed at baseline,1month and 3 months. Plaque Index Gingival Index Probing Pocket Depth Clinical Attachment Level (CAL)

MICROBIOLOGICAL PARAMETERS are Supra and subgingival Plaque samples will be collected at baseline and at 1 month after

treatment for microbiological assessment.

In the treatment procedure, the test group will first undergo complete scaling and root planing followed by amoxicillin and metronidazole nanofibers will be placed in the periodontal pockets. The control group will complete ultrasonic scaling and root planing but no nanofibers will be applied. For the microbial assay, supra- and subgingival plaque samples will be collected from patients diagnosed with stage II periodontitis at baseline and again after 1 month using a sterile curette. These samples will be transported to the microbiology lab for aerobic and anaerobic bacterial culture analysis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Age group 18 years to 50 years Patients diagnosed with periodontitis stage II Site specific criteria is Probing pocket depth greater than or equal to 5mm and less than 8mm.

Exclusion Criteria

Chronic smokers Patients with any other systemic disorders Patients who are unwilling to participate in the study Pregnant and lactating mothers Patients allergic to amoxicillin and metronidazole.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiological parameters: Supra and subgingival micro flora will be assessed by aerobic and anaerobic bacterial culture in both the groups	Clinical parameters: Assessed at baseline, 1 month and 3 months \| Microbiological parameters: Baseline and 1 month
Clinical parameters: PI(Plaque index),GI(Gingival index),PPD(Probing pocket depth),and CAL(Clinical attachment levvel) in test and control group	Clinical parameters: Assessed at baseline, 1 month and 3 months \| Microbiological parameters: Baseline and 1 month

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Kamineni Institute of Dental Sciences
🇮🇳
Nalgonda, TELANGANA, India
Kamineni Institute of Dental Sciences
🇮🇳Nalgonda, TELANGANA, India
DR Uppunuti Swathi
Principal investigator
09177231718
swathi.uppunuti999@gmail.com