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CTRI Number  CTRI/2024/09/073827 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the effect of mucoadhesive film with silver nano particles and mucoadhesive film with curcumin on wound healing after periodontal surgery - A randomized controlled trial 
Scientific Title of Study   Comparative efficacy of mucoadhesive film containing silver nano particles and mucoadhesive film containing curcumin on wound healing after periodontal surgery – A randomized controlled trial 
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 Nivethitha D 
Designation  Post graduate student 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Room No. 9, Department of Periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka India

Belgaum
KARNATAKA
590010
India 
Phone  9677789433  
Fax    
Email  nivethithadivakar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelamma Shetti 
Designation  Reader 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Room no.9, Department of Periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  7795447015  
Fax    
Email  neelushetti1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nivethitha D 
Designation  Post graduate student 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Room no.9, Department of Periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9677789433  
Fax    
Email  nivethithadivakar@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka 
 
Primary Sponsor  
Name  Dr. Nivethitha D 
Address  KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka 
Type of Sponsor  Other [Self sponsored] 
 
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 Nivethitha  KLE VK Institute Of Dental Sciences  Room No. 9, Department of Periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi 590010, Karnataka
Belgaum
KARNATAKA 
9677789433

nivethithadivakar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  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 
Intervention  Mucoadhesive film containing curcumin  Assessing the wound healing efficacy of a mucoadhesive film containing curcumin and Periodontal dressing Will be assessed at 7th day and 14th day 
Intervention  Mucoadhesive film containing silver nano particles  Assessing the wound healing efficacy of a mucoadhesive film containing silver nano particles and Periodontal dressing Will be assessed at 7th day and 14th day  
Comparator Agent  Periodontal dressing   Assessment of wound healing with only Periodontal dressing Will be assessed at 7th day and 14th day 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1.Systemically healthy patients requiring periodontal therapy - periodontal flap surgery.
2.Patients between the age of 35 – 60 years.
3.Patients willing to participate in the study.
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1.Pregnant Women and Lactating Mothers.
2.Patients who are medically compromised and are under therapeutic regimen that may alter the probability of tissue healing.
3.Patients who underwent periodontal therapy in the past 6 months.
4.Patients who were on antibiotic therapy or NSAIDs therapy in the past 6 months.
5.Smokers or patients with any habit history.
6.Patients who are known or suspected to be allergic to curcumin and silver.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Wound Healing Score -
Wound healing Index (Landry, Turnbull and Howley – 1988) 
7th day
14th day 
 
Secondary Outcome  
Outcome  TimePoints 
NUMBER OF COLONY FORMING UNITS (CFU/ml)  Baseline and 7th day 
 
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   N/A 
Date of First Enrollment (India)   25/09/2024 
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 Yet Recruiting 
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  

Ø   Periodontitis is one of the most common ailments affecting the teeth, leading to the destruction of the supporting and surrounding tooth structure. Periodontal disease is the most common oral disease with a prevalence of 20-50% of the world population, and has a multifactorial origin, with the primary causative agent being the bacterial colonization in the oral tissue.

Ø  The periodontal wound healing process is slightly different from cutaneous wound healing and is similar to fetal healing, being almost scar-free. The periodontal dressings are protective material placed over the wound created by periodontal surgical procedures. They are commonly placed following various periodontal surgical procedures including gingivectomies, flap procedures, crown lengthening, mucogingival procedure, and most commonly after periodontal regeneration.

Ø   Periodontal dressing protects the surgical wound from saliva, food stagnation and trauma, thus making post-operative period comfortable and healing more favourable. Thus, the periodontal dressing protects the wound indirectly from infection. The main objectives of periodontal dressings are to obtain an optimized healing and ensure minimum discomfort to the patient. Wound protection and patient’s comfort are the main purpose of periodontal dressing.  However, a number of clinical trials have reported plaque accumulation beneath these dressings, leading to inflammation in the tissues and transient bacteremia. The value of periodontal dressing and their effects on periodontal wound healing has been questioned for many years.

Ø  This encouraged the invention of drug-loaded dressings, which act as a barrier to microorganisms when applied on a wound, thus stimulating the wound-healing environment by preventing secondary infections. Various agents have been tested such as chlorhexidine digluconate salts, zinc bacitracin, and tetracycline.  Among the different antimicrobial agents, silver has been used widely due to many benefits, including multi-level antibacterial effect on cells with low systemic toxicity.

Ø  The silver nanoparticles (NPs) are being increasingly used nowadays as wound dressings, contraceptive devices, surgical instruments, and bone prostheses. There is increasing literature to support that silver NPs can promote wound healing through anti-inflammatory properties. Furthermore, the levels of pro-inflammatory markers have been found to be significantly reduced in animals treated with silver nanoparticles. These results suggest that silver nanoparticles can be involved in altering or suppressing inflammatory events in the early phases of wound healing, and the use of silver nanoparticles may be clinically applicable to many conditions. A systematic review by Song and Gealso (2019) compiled in sufficient details about their applications in prevention of oral diseases including periodontal infections and peri-implant infections inhibiting both Gram-positive and Gram-negative species.

Ø  It has been identified that along with the currently available drugs for wound healing, herbal extracts have also been found to have wound healing potential. Curcumin is well known for its anti-inflammatory, antimicrobial, antioxidant and wound-healing properties. Curcumin also has a good safety profile and is termed as a generally regarded as safe ingredient by the US Food and Drug Administration. In addition to this, it is also highly economical, is easily available, and has a multitargeted mode of action on the various molecular signalling pathways, unlike NSAIDs. In spite of the promising biological effects, the clinical application of curcumin is still a challenge due to its poor bioavailability due to poor absorption, rapid metabolism, and rapid systemic elimination.

Ø  To overcome these limitations, curcumin has also been studied in the form of local drug delivery agents such as gels, mouth rinses, subgingival irrigants, and curcumin incorporated collagen fibres, which have shown to achieve a higher concentration in the oral cavity as compared to the oral administration. 

Ø  Mucoadhesive films are a form of local drug delivery system which employs the transmucosal route of drug delivery. The films provide release of drug at the desired site which gives better drug absorption. There is limited literature available on wound healing potential of curcumin in the form of a mucoadhesive film after periodontal surgeries.

Ø   Hence, keeping all these data in mind, the aim of this study is to assess and compare the effectiveness of mucoadhesive film containing silver nano particles and mucoadhesive film containing curcumin in wound healing after periodontal surgery.              

 
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