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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  
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 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  
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  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.

 
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