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
|
|
Primary Sponsor
|
Name |
UPPUNUTI SWATHI |
Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
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 |
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
|
|
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. |