| CTRI Number |
CTRI/2026/01/101534 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Using Light Therapy Along with Gum Surgery to Treat Chronic Gum Disease |
|
Scientific Title of Study
|
Synergistic effect of photodynamic therapy as an adjunct to open flap debridement in the management of chronic 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 |
Dr. Vartika Gupta |
| Designation |
PostGraduate |
| Affiliation |
Institute of dental studies and technologies |
| Address |
Department of periodontology institute of dental studies and technologies kadrabad modinagar ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
07455995900 |
| Fax |
|
| Email |
vartika13sep1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish khatri |
| Designation |
Professor and vice principal(administration) |
| Affiliation |
Institute of dental studies and technologies |
| Address |
Department of periodontology institute of dental studies and technologies kadrabad modinagar ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi bansal |
| Designation |
Professor and head |
| Affiliation |
Institute of dental studies and technologies |
| Address |
Department of periodontology institute of dental studies and technologies kadrabad modinagar ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology,institute of dental studies and technologies,kadrabad modinagar ghaziabad uttar pradesh, 201201 india |
|
|
Primary Sponsor
|
| Name |
Institute of dental studies and technologies |
| Address |
Institute of dental studies and technologies,kadrabad modinagar,uttar pradesh,india-201201 |
| Type of Sponsor |
Research institution |
|
|
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 Vartika Gupta |
Institute of dental studies and technologies |
Institute of dental studies and technologies department of periodontology room no 7 kadrabad modinagar uttar pradesh india-201201
Ghaziabad
UTTAR PRADESH |
7455995900
vartika13sep1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Open flap debridement in chronic periodontitis |
A crevicular incision will be given, using a number 15 surgical blade. A full thickness mucoperiosteal flap will be reflected using periosteal
elevator. |
| Comparator Agent |
Photodynamic Therapy as an adjunct to open flap
debridement |
Following open flap debridement, Photodynamic therapy assisted periodontal pocket
therapy will be performed using a Diode laser a wavelength 810 nm. A single session of
this technique will be repeated during each surgical procedure. The test sites will be
coated with photosensitizing dye using a blunt side release cannula. The low-level laser
therapy (LLLT) effect of the last zone of the beam profile generated by 810 nm diode
laser will be used to activate the dye at a power output of 100 mW in a continuous
wave. Its photonic energy will be delivered with a 400 µm fibre in non-contact mode
and applied for 30 s/spot (total 4 spots per tooth). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients from the age range of 20to50 yearsSystemically healthy patients Minimum two teeth maximum probing depth in two different quadrants with residual probing depth of more than or equal to 5mm after initial therapy scaling and root planing Plaque and Gingival index less than orequal to 1 |
|
| ExclusionCriteria |
| Details |
Smokers Pregnant and lactating females History of tobacco consumption Patients that have undergone any periodontal surgery within last six months |
|
|
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 |
Fixed reference
point (FRP) will be taken on the stent. a) Probing Pocket Depth (PPD) = (FRP-BOP) – (FRP-GM)
b) Clinical attachment Level (CAL) = (FRP-BOP) – (FRP-CEJ)
c) Gingival Recession (GR) = (FRP-GM) –(FRP-CEJ) |
Various clinical parameters will be recorded at baseline (on the day of surgery) and
follow up visits after 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Full Mouth Plaque Index (Sillness and Loe 1964)
Full Mouth Gingival Index (Loe and Sillness 1963)
Gingival Bleeding Index(Ainamo and Bay 1975) |
Various clinical parameters will be recorded at baseline (on the day of surgery) and
follow up visits after 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/01/2026 |
| 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
|
This study was conducted and compiled by Dr. Vartika Gupta, Dr. Manish Khatri, Dr. Mansi Bansal , Dr. Nisha Parveen, Dr. Mohd. Rehan , Dr. Pratiksha, Dr. Neeru at Department of Periodontology, Institute of Dental Studies and Technologies , Kadrabad ,Modinagar, Uttar Pradesh, India.The study is a randomized control trial to compare Photodynamic Therapy as an adjunct to Open Flap Debridement and Open Flap Debridement alone in the treatment of chronic periodontitis. |