| CTRI Number |
CTRI/2024/04/066528 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see which treatment procedures improves wound healing either gel containing 2% ibuprofen and 2% povidone iodine or systemic pain killers |
|
Scientific Title of Study
|
The effect of gel containing 2% Ibuprofen and 2% Povidone Iodine on wound healing after periodontal surgery: A Randomized Control 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 |
Unnati Nayak |
| Designation |
Undergraduate student |
| Affiliation |
KLE University |
| Address |
Department of Periodontics,
KLE VK Institute Of Dental Sciences,
Nehru Nagar,
Belagavi.
Belgaum KARNATAKA 590010 India |
| Phone |
6382775978 |
| Fax |
|
| Email |
nivestanite@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neelamma Shetti |
| Designation |
Reader |
| Affiliation |
KLE University |
| Address |
Department of Periodontics,
KLE VK Institute Of Dental Sciences,
Nehru Nagar,
Belagavi.
Belgaum KARNATAKA 590010 India |
| Phone |
7795447015 |
| Fax |
|
| Email |
neelushetti1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Unnati Nayak |
| Designation |
Undergraduate student |
| Affiliation |
KLE University |
| Address |
Department of Periodontics,
KLE VK Institute Of Dental Sciences,
Nehru Nagar,
Belagavi.
Belgaum KARNATAKA 590010 India |
| Phone |
6382775978 |
| Fax |
|
| Email |
nivestanite@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE VK Institute Of Dental Sciences,
Nehru nagar,
Belagavi590010,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education Research |
| Address |
KLE VK Institute Of Dental Sciences
Nehru nagar
Belagavi 590010 |
| Type of Sponsor |
Research institution |
|
|
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 Unnati Nayak |
KLE VK Institute Of Dental Sciences |
Department of Periodontics,
KLE VK Institute Of Dental Sciences,
Nehru Nagar,
Belagavi 590010,
Karnataka Belgaum KARNATAKA |
6382775978
nivestanite@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 |
Gel containing 2% Ibuprofen and 2% Povidine Iodine |
Effect of gel containing 2% Ibuprofen and 2% Povidine Iodine on wound healing after periodontal surgery |
| Comparator Agent |
Systemic administration of Ibuprofen and Povidine Iodine mouthwash. |
Effect of gel containing 2% Ibuprofen and 2% Povidine Iodine on wound healing after periodontal surgery |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in between the age group of 25-60 years.
2. Patients with chronic periodontitis indicated for flap surgery.
3. Patients who give informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Patients with history of any systemic diseases.
2. Patients who are lactating mothers and pregnant women.
3. Patients who have undergone any periodontal therapy 6 months prior to the study.
4. Patients who have taken any anti-inflammatory drugs, antibiotics or mouth rinse over past 3 months.
5. Patients with known hypersensitivity to Ibuprofen or Povidine Iodine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing Index |
Wound Healing Index- 1st day,2nd day, 3rd day, 7th day & 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale |
Visual Analog Scale 1st day,2nd day, 3rd day & 7th day |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
11/05/2024 |
| 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="0" 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
|
· One of the major problems in dentistry is the post operative complications; the most common ones are pain, bleeding, infections, swelling and trismus.1 The meticulous assessment and restraining these symptoms, particularly pain and infections, is efficacious to achieve patient’s solace. · Pain is an unpleasant emotional experience usually initiated by noxious stimulus and transmitted over a specialized neural network to CNS where it is interpreted as such.2 The pain after operation is increased by inflammation amalgamated with primary repair. The use of non-steroidal anti-inflammatory drugs to control pain is routinely practiced. · One of the NSAID’s is Ibuprofen. It is derived from Propionic acid. It acts by inhibiting the enzyme Cyclooxygenase (COX), which is required for synthesis of Prostaglandin (PG) via Arachidonic acid pathway.3 · An additional embodied aspect is the occurrence of secondary infections. This is encouraged by the microbial activity in the oral cavity. Amongst the different antimicrobial agents, Povidine Iodine has been widely used due to its benefits, including rapid wound healing and broad-spectrum antimicrobial activity against perio pathogens. · The antimicrobial activity of Povidine Iodine occurs after the Iodine disassociates from the complex. Once in free form, Iodine rapidly penetrates microbial cell membrane and interacts with proteins, nucleotides and fatty acids in the cytoplasm and cytoplasmic membrane. This interaction ultimately results in rapid cell death.4 · In the management of periodontal flap surgeries, in order to obtain high antimicrobial activity and low systemic complications local drug delivery system can be used. One such drug delivery agent is gel form. · Gels are semisolid devices containing an adequate concentration of drug and delivered at specific sites. They are easy to prepare and administer. They further possess a property of bio adhesivity that enhances the retention time at the operated site.5 · Acknowledging the aforementioned advantages of the gel form, it might be prudent to utilize the analgesic effect of Ibuprofen and antimicrobial properties of Povidine Iodine as the fundamental elements of the gel. |