| 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
|
|
|
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
|
|
|
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. |