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CTRI Number  CTRI/2025/08/093103 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   Study to Compare Infection Levels on Regular and curcumin-Coated Stitches Used in Gum Surgery 
Scientific Title of Study   Comparative evaluation of anti-bacterial effect of silk suture coated with curcumin nano particles and uncoated silk suture in periodontal flap surgery: A Microbiological 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 Vidisha Naik 
Designation  MDS Part I student 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune 
Address  Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune Satara Road Katraj Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9373305772  
Fax    
Email  vidishanaik18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Waghmare 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune 
Address  Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune Satara Road Katraj Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9850846820  
Fax    
Email  pramodw42@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidisha Naik 
Designation  MDS Part I student 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune 
Address  Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune Satara Road Katraj Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9373305772  
Fax    
Email  vidishanaik18@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology Bharati Vidyapeeth Dental College and Hospital Pune Katraj Ambegaon Dhankawadi Pune Maharashtra 411043 India 
 
Primary Sponsor  
Name  Dr Vidisha Naik 
Address  Department of Periodontology Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune Satara Road Katraj Dhankawadi Pune Maharashtra 411043 
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 Vidisha Naik  Bharati Vidyapeeth Deemed to be University Dental College and Hospital  Department of Periodontology, Room No 03 Bharati Vidyapeeth Deemed to be University Dental College and Hospital Pune Satara Road Katraj Ambegaon BK Rd Dhankawadi Pune 411043 Maharashtra
Pune
MAHARASHTRA 		 9373305772

vidishanaik18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Bharati Vidyapeeth Deemed to be University Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Generalised Periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcumin nanoparticle coated silk suture  The intervention agent is a non-absorbable silk surgical suture 3-0 coated with curcumin nanoparticles. Curcumin a natural polyphenolic compound derived from Curcuma longa (turmeric is known for its antibacterial and anti inflammatory properties. The coating process involves nanoparticle formulation of curcumin to improve surface adherence and antibacterial efficacy. The sutures are sterilized and used in periodontal flap surgery to evaluate bacterial colonization. Alternate sites within the same quadrant will be sutured with curcumin nanoparticle coated silk suture during periodontal flap surgery 
Comparator Agent  Uncoated silk suture  The comparator agent used in this study is a standard commercially available non-absorbable silk surgical suture of size 3-0 commonly used in periodontal surgeries. It is sterile and uncoated serving as the control material to evaluate baseline bacterial adherence on suture surfaces. Alternate sites within the same quadrant of the mouth will be sutured with this uncoated silk suture during periodontal flap surgery 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with age between 25 to 60 years
Patients with Chronic Generalized Periodontitis
Patients with at least 30 percent of the sites with pocket probing depth more than or equal to 5 mm after phase I therapy
Patients willing to participate in the study with written informed consent
 
 
ExclusionCriteria 
Details 
Patients who are pregnant or lactating mothers
Patients who are immunocompromised patients
Patients with any history of allergy to any material used in the study
Patients who have undergone antibiotic therapy in past 3 months
Patients with any systemic diseases
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The total microbial count on curcumin nanoparticle coated suture sample and uncoated suture sample will be calculated after culturing on agar plate.  The microbiological analysis will be done on the suture samples obtained from each study participant 7 days after the flap surgery 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   21/09/2025 
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="0"
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  

This in vivo clinical study aims to assess and compare the antibacterial efficacy of silk sutures coated with curcumin nanoparticles and conventional uncoated silk sutures used during periodontal flap surgery. Curcumin, a natural compound with proven antibacterial and anti-inflammatory properties is hypothesized to reduce bacterial colonization when coated on sutures. A total of 10 patients with chronic generalized periodontitis, having more than or equal to 30 percent sites with pocket depth more than or equal to 5 mm after phase I therapy will be selected from the Outpatient Department of Periodontology Bharati Vidyapeeth Dental College & Hospital Pune.

Each patient will undergo periodontal flap surgery during which both types of sutures that is coated and uncoated will be alternately used in the same surgical site. After 7 days, sutures will be removed and transferred to phosphate-buffered saline for microbiological analysis. Using the roll plate method total bacterial colony-forming units will be counted to determine microbial load. The findings are expected to guide the use of antibacterial-coated sutures to minimize postoperative infection and improve healing in periodontal surgery.

 
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