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CTRI Number  CTRI/2025/07/090438 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 07/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Assessment of gums regeneration using bleeding induced laser therapy 
Scientific Title of Study   Assessment of gingival papilla regeneration using an innovative approach: Hemolaser therapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheetal G Naik 
Designation  Post Graduate 2nd year MDS  
Affiliation  The Oxford Dental College, Bangalore 
Address  Room no - 3, Dept of Periodontology, 2nd floor, The Oxford Dental College, Bommanahalli, Bangalore Karnataka - 560068

Bangalore
KARNATAKA
560068
India 
Phone  08105821853  
Fax    
Email  sheetalgnaik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr BS Jagadish Pai  
Designation  Professor and HOD Periodontology  
Affiliation  The Oxford Dental College, Bangalore  
Address  Room no - 3, Dept of Periodontology, 2nd floor, The Oxford Dental College , Bommanahalli, Bangalore Karnataka - 560068

Bangalore
KARNATAKA
560068
India 
Phone  9448163710  
Fax    
Email  bsjpai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr BS Jagadish Pai  
Designation  Professor and HOD Periodontology  
Affiliation  The Oxford Dental College, Bangalore  
Address  Room no - 3, Dept of Periodontology, 2nd floor, The Oxford Dental College , Bommanahalli, Bangalore Karnataka - 560068

Bangalore
KARNATAKA
560068
India 
Phone  9448163710  
Fax    
Email  bsjpai@yahoo.com  
 
Source of Monetary or Material Support  
The Oxford Dental College and Hospital, Bommanahalli, Bangalore, Karnataka - 560068 
 
Primary Sponsor  
Name  Dr Sheetal G Naik 
Address  Room no - 3, Dept of Periodontology, 2nd floor, The Oxford Dental College , Bommanahalli, Bangalore Karnataka - 560068 
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 Sheetal G Naik  The Oxford Dental College  Room no - 3, Dept of Periodontology, 2nd floor, The Oxford Dental College , Bommanahalli, Bangalore Karnataka - 560068
Bangalore Rural
KARNATAKA 
08105821853

sheetalgnaik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE OXFORD DENTAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z710||Person encountering health services to consult on behalf of another person,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hemolaser Therapy  Bleeding is induced at certain points on the gingiva followed by Photobiomodulation therapy. Papillary re-generation assessed after 7, 14 and 21days  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age group of 18-65 years.
2. Individuals with class 1 and class 11 papillary loss (Norland and Tarnow 1998)
3. Good oral hygiene
4. Adequate width of gingiva 
 
ExclusionCriteria 
Details  1. Smokers.
2. Any systemic illness that can alter the outcome of the procedure
3. Edema, bleeding inflammation and gum retraction
4. Gingival alterations
5. Dental defects like abfractions, irregularities or excess on the nearby dental surface
6. Abnormal frenal attachment
7. Allergy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the papillary gain with hemolaser therapy during first, second and third
sessions on day 1, day 7 and day 14 respectively and during follow up period after 21 days. 
To assess and compare the papillary gain with hemolaser therapy during first, second and third
sessions on day 1, day 7 and day 14 respectively and during follow up period after 21 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of black triangles  21 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 3 
Date of First Enrollment (India)   18/07/2025 
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="0"
Days="21" 
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  
As a part of smile’s harmony, interdental papilla plays an important role in orofacial esthetics. Loss of 
interdental papilla of gingiva can lead to black spaces in odontology, which affects the smile esthetics
and leads to phonetics and functional damage.1 This black triangle can even cause food impaction. The 
etiology of this loss is mainly because of gingival inflammation, attachment loss, resorption of 
interproximal bone height and periodontal surgical therapy. Growth factors, platelet derivatives and 
low level laser therapy has been used previously for papillary regeneration, but papillary reconstruction 
is most challenging problem because of the minor blood supply.
2 Surgical reconstruction of interdental papilla also presents as challenge in obtaining good results.3 Photo biomodulation therapy (PMBT) 
modulates biologic activity and has shown to reduce inflammation and pain, prevent necrosis and has 
shown to stimulate healing of wound and regeneration of tissues. PMBT has also been proven to
enhance the production of adenosine triphosphate, vasodilatation and tissue regeneration.4 Hemolaser 
therapy is a modified PBMT which regenerates papilla and fills the black triangles. The aim of this 
study is to evaluate the effectiveness and efficiency of hemolaser therapy on papillary regeneration.

 
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