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CTRI Number  CTRI/2023/09/057780 [Registered on: 18/09/2023] Trial Registered Prospectively
Last Modified On: 16/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the therapeutic effects of special kind of laser to excise the white patch with tumeric tablets given & without tumeric tablets in managing the white lesion 
Scientific Title of Study   Comparative evaluation of Therapeutic effects of diode laser with curcumin and diode laser without curcumin in the management of homogenous type of oral leukoplakia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SOWMIYA J 
Designation  POSTGRADUATE 
Affiliation  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES 
Address  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
Kancheepuram
TAMIL NADU
606604
India 
Phone  9943516571  
Fax    
Email  sowmiyajaisankar2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRKRSHAKILA 
Designation  PROFESSOR 
Affiliation  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES 
Address  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
Kancheepuram
TAMIL NADU
603308
India 
Phone  9894079164  
Fax    
Email  shakilasuresh100@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DRKRSHAKILA 
Designation  PROFESSOR 
Affiliation  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES 
Address  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET

TAMIL NADU
600073
India 
Phone  9894079164  
Fax    
Email  shakilasuresh100@yahoo.com  
 
Source of Monetary or Material Support  
KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES 
 
Primary Sponsor  
Name  SOWMIYA  
Address  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, GROUND FLOOR, DENTAL WING OF HOSPITAL ROAD, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET 
Type of Sponsor  Other [SELF] 
 
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 SOWMIYA J  KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NO-4, GROUND FLOOR, DENTAL WING OF HOSPITAL ROAD, CHINNAKOLAMBAKKAM, PALAYANOOR POST, MADHURANTHAGAM, CHENGALPET
Kancheepuram
TAMIL NADU 		 9943516571

sowmiyajaisankar2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KARPAGA VINAYAGA INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, (2) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DIODE LASER  Diode laser is used to excision of lesion for patients with histopathologically proven homogenous type of leukoplakia measure the lesion size, healing index pain score after excision at 1st week,2nd week & 1st month. 
Comparator Agent  with and without curcuim  for one group, curcumin is given and for other without curcumin along with diode laser, measure the lesion size, healing index and pain score at 1st week,2nd week & 1st month 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Age group- 30- 75 years
Both males and females
Patients with homogenous type of leukoplakia
Patients who are ready to quit the habit- smoking, tobacco & alcohol habits
Patients who had not taken any treatment earlier for leukoplakia
 
 
 
ExclusionCriteria 
Details  Patients on topical corticosteroids
Patients with chronic debilitating disease
Patients with non-homogenous type of leukoplakia
Lesions on the tongue and floor of mouth
Pregnancy and lactating mothers
Patients with other mucosal lesions like oral submucous fibrosis, malignant lesions
Patients who are already diagnosed as cancer patients
History of hypersensitivity to curcumin
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the pain score, size of the lesion & healing index in patients treating diode laser with curcumin in oral leukoplakia patients
To assess the pain score, size of the lesion & healing index in patients treating diode laser without curcumin in oral leukoplakia patients
To compare the pain score, size of lesion, healing index in both groups. 		 two months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the recurrence of lesion & malignant transformation in both the groups  two months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   26/09/2023 
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="2"
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  
•Oral cancer is the sixth most common cancer worldwide.
•Oral cancer leaded by noticeable clinical changes in the form of white or red patches in oral mucosa & set forth the theory of two-step process of cancer development.
•The changes in oral cavity are labelled as “potentially malignant disorders (PMD) of oral cavity .
•Presently, it has multiple treatment modalities such as surgical and conservative methods. The commonly used conservative modalities are antifungal ointments, glycerine soap massage, vitamin A supplements, Antioxidants
•Recently lasers have also been tried as a treatment modality for PMD & amazing results were proved.
•Diode laser is commonly used as a surgical soft tissue laser for the complete excision of the lesion, which provides promising results without any complication & without compromising health and function of the patients.
•With the advancement in the field of medicine, antioxidants have gained a lot of importance because of their potential as  prophylactic and therapeutic agents in potentially malignant disorders.
•They have anti-inflammatory, analgesic, antioxidant and anticancer properties and have been found to constrain many disease process
•Recently lasers have also been tried as a treatment modality for PMD & amazing results were proved.
•Diode laser is commonly used as a surgical soft tissue laser for the complete excision of the lesion, which provides promising results without any complication & without compromising health and function of the patients.
•With the advancement in the field of medicine, antioxidants have gained a lot of importance because of their potential as  prophylactic and therapeutic agents in potentially malignant disorders.
•They have anti-inflammatory, analgesic, antioxidant and anticancer properties and have been found to constrain many disease process
AIM

To evaluate the effects of diode laser with curcumin as an adjuvant in treating oral leukoplakia.

 OBJECTIVES: 

•To determine the effectiveness of the diode laser with curcumin as an adjuvant and without curcumin in treating oral leukoplakia.
•To assess the pain score, size of the lesion, healing index, recurrence of the lesion and malignant transformation.

OUTCOME

•        The outcomes assessed were a change in the pain score, a change in the burning sensation score, a change in the size of the lesion, complete clinical resolution of the lesion.

 
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