| CTRI Number |
CTRI/2025/11/096919 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"Comparing Antibiotic and Ointment-Coated Stitches for Better Healing" |
|
Scientific Title of Study
|
Comparison of antimicrobial efficacy of Ciprofloxacin vs Pomade coated silk sutures: A Clinical and 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 |
AMBATI MANASA |
| Designation |
READER |
| Affiliation |
panineeya mahavidhyalaya institute of dental sciences and research centre |
| Address |
Room no 101, 1st floor department of periodontitics, road no.5, panineeya mahavidhyalaya institute of dental sciences and research centre, kamalanagar, dilshuknagar,hyderabad-500060, telengana india.
Hyderabad
TELANGANA
500060
India |
| Phone |
919949727898 |
| Fax |
|
| Email |
dr.manasa5986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMBATI MANASA |
| Designation |
READER |
| Affiliation |
panineeya mahavidhyalaya institute of dental sciences and research centre |
| Address |
Room no 101, 1st floor department of periodontitics, road no.5, panineeya mahavidhyalaya institute of dental sciences and research centre, kamalanagar, dilshuknagar,hyderabad-500060, telengana india.
Hyderabad
TELANGANA
500060
India |
| Phone |
919949727898 |
| Fax |
|
| Email |
dr.manasa5986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RACHAKONDA KAVYA |
| Designation |
post graduate |
| Affiliation |
panineeya mahavidhyalaya institute of dental sciences and research centre |
| Address |
Room no 101, 1st floor department of periodontitics, road no.5, panineeya mahavidhyalaya institute of dental sciences and research centre, kamalanagar, dilshuknagar,hyderabad-500060, telengana india.
Hyderabad
TELANGANA
500060
India |
| Phone |
08106507240 |
| Fax |
|
| Email |
kavyarachakonda13@gmail.com |
|
|
Source of Monetary or Material Support
|
| panineeya institute of dental sciences and research centre
pincode 500060 india |
|
|
Primary Sponsor
|
| Name |
Panineeya mahavidhyalaya institute of dental sciences |
| Address |
Room no 101, 1st floor department of periodontitics, road no.5, panineeya mahavidhyalaya institute of dental sciences and research centre, kamalanagar, dilshuknagar,hyderabad-500060, telengana india. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| RACHAKONDA KAVYA |
panineeya institue of dental sciences and research centre |
Room no 101, 1st floor department of periodontitics, road no.5, panineeya mahavidhyalaya institute of dental sciences and research centre, kamalanagar, dilshuknagar,hyderabad-500060, telengana india.
Hyderabad
TELANGANA |
08106507240
kavyarachakonda13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| intistuitional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group(1) ciprofloxacin coated suture material |
3 months |
| Comparator Agent |
group(2) pomade coated suture material |
3 months |
| Comparator Agent |
group(3) uncoated silk suture materials |
3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients in the age-group of 18–45 years.
Stage II grade B periodontitis.
No antimicrobial therapy prior to 3 months.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic illness.
Pregnant women.
Lactating women.
Patients allergic to ciprofloxacin, iodoform and calendula oil.
Smokers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Whether ciprofloxacin coated suture material is superior to pomade coated suture material |
base line and one week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| 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="0"
Months="3"
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
|
Surgical site infections are common after periodontal surgeries, with sutures contributing to infection risk by acting as reservoirs for bacteria. Proper wound closure essential for preventing SSIs. Studies suggest that using antibacterial-coated sutures can help reduce infection rates. Pomade is a formulation containing iodoform 40 percent and calendula oil 5 percent. Iodoform, an effective germicidal agent with anti-infective properties, is one of the key components in the pomade that is prepared. Calendula oil, the second component, has the triterpenoids present which are thought to be the drug’s most potent anti-inflammatory ingredients.Ciprofloxacin is a broad spectrum antibiotic. It has an extremely wide range of antibacterial activity, inhibiting aerobic and anaerobic cocci and bacilli at low concentrations. Its mechanism of action is through inhibition of bacterial DNA gyrase and topoisomerase IV. Escherichia coli is a gram negative, facultative anaerobic, rod-shaped, coliform bacterium. E. coli cause suture site infections after dental or oral surgeries. Staphylococcus aureus is a Gram-positive, coagulase-positive coccus that is often found in clusters resembling bunches of grapes. Streptococcus pyogenes is a Gram-positive, catalase-negative coccus that belongs to Group A of the Streptococcus family. E. coli, staphylococcus aureus and streptococcus pyogenes cause suture site infections such as tooth extractions or periodontal procedures |