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CTRI Number  CTRI/2025/05/086195 [Registered on: 02/05/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Smarter Way to Fight Gum Infections: Local Delivery of Antibiotics Using Nanofibres"  
Scientific Title of Study   Clinico microbiological evaluation of the efficacy of local delivery of Amoxicillin and Metronidazole Nanofibers as an adjunct to scaling and root planing in Periodontitis Stage II Patients 
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 Uppunuti Swathi 
Designation  Post Graduate Student 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Nalgonda
TELANGANA
508254
India 
Phone  9177231718  
Fax  08682272296  
Email  swathi.uppunuti999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Juliet Josephin 
Designation  Reader 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Nalgonda
TELANGANA
508254
India 
Phone  09989183060  
Fax  08682272296  
Email  periomds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Juliet Josephin 
Designation  Reader 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Nalgonda
TELANGANA
508254
India 
Phone  09989183060  
Fax  08682272296  
Email  periomds@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  UPPUNUTI SWATHI 
Address  KAMINENI INSTITUTE OF DENTAL SCIENCES 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Uppunuti Swathi  Kamineni Institute of Dental Sciences  Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda Department of Periodontics first floor Room number six Kamineni Institute of Dental Sciences Sreepuram Narketpally Nalgonda
Nalgonda
TELANGANA 
09177231718
08682272296
swathi.uppunuti999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kamineni Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Scaling and root planing  scaling and root planing will be done in periodontitis stage II  
Intervention  Scaling and root planing plus amoxycillin and metronidazole nanofibres  complete scaling and root planing will be done followed by amoxycillin and metronidazole nanofibers will be placed in periodontal pocket 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical parameters: PI(Plaque index),GI(Gingival index),PPD(Probing pocket depth),and CAL(Clinical attachment levvel) in test and control group
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 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   01/07/2025 
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="1"
Months="6"
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  
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.
 
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