| CTRI Number |
CTRI/2026/03/106131 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Spirulina In Situ Nanogel and Light Therapy: A New Approach to Treating Periodontitis. |
|
Scientific Title of Study
|
Assess and Compare The Efficacy of Insitu Spirulina Nanogel with and without Antimicrobial Photodynamic Therapy as an adjunct to Scaling and Root Planning in Patients with Stage 2 Grade A Periodontitis- A Randomized Controlled Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelamma A Shetti |
| Designation |
Reader |
| Affiliation |
KLE VK Institute Of Dental Science Belgavi |
| Address |
Jadhav nagar Belgaum
room no 9
department of periodontics
nehru nagar belgaum
Belgaum
KARNATAKA
590019
India |
| Phone |
07795447015 |
| Fax |
|
| Email |
neelushetti1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelamma A Shetti |
| Designation |
Reader |
| Affiliation |
KLE VK Institute Of Dental Science Belgavi |
| Address |
Jadhav nagar Belgaum
department of periodontics
nehru nagar
room no 9
second floor
Belgaum
KARNATAKA
590019
India |
| Phone |
07795447015 |
| Fax |
|
| Email |
neelushetti1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neelamma A Shetti |
| Designation |
Reader |
| Affiliation |
KLE VK Institute Of Dental Science Belgavi |
| Address |
Jadhav nagar Belgaum
Department of periodontics
nehru nagar
room no 9
second floor
nehru nagar belgaavi 590010
Belgaum
KARNATAKA
590019
India |
| Phone |
07795447015 |
| Fax |
|
| Email |
neelushetti1@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE VK Institute of dental sciences
nehru nagar
belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Neelamma Shetti |
| Address |
Department of Periodontics
KLE VK Institute of Dental Sciences
nehru nagar belgaum, karnataka
590010 INDIA
phone 0831-2470362
E mail: principal@kledental-bgm.edu.in
KAHER
Belagavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Neelamma Shetti |
Department of Periodontics room no 9 second floor |
KLE VKInstitute of Dental Sciences
KAHER
nehru nagar belgavi 590010 India
Phone :0831-2470362
FAX :0831-2470640
E mail:principal@kledental-bgm.edu.in
Belgaum
KARNATAKA |
7795447015
0831-2470640
neelushetti1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee |
Approved |
| Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy subjects with periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
photodynamic therapy |
photodynamic therapy alone |
| Intervention |
Spirulina dye |
the dye will be used in the treatment of periodontitis along with photodynamic therapy |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
minimum pocket probing depth of 5 mm |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| natural spirulina dye used for photodynamic therapy |
Baseline ,7 days , 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| treatment for periodontitis |
baseline 7 days 14 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="1"
Months="0"
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
|
study focuses on using the natural dye Spirulina which has excellent anti microbial properties . so in this trail we are checking the efficacy of Insitu nano gel containing spirulina using photodynamic therapy , adjunct to scaling and root planing in the treatment of chronic periodontitis |