| 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
|
|
|
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
|
|
|
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.
|