FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087888 [Registered on: 29/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of the efficacy of transgingival photodynamic therapy (Tg-PDT) using blue light LED as an adjunct to subgingival mechanical instrumentation - A Randomized Controlled Trial 
Scientific Title of Study   Evaluation of the efficacy of transgingival photodynamic therapy (Tg-PDT) using blue light LED (430-490nm) as an adjunct to subgingival mechanical instrumentation - A Randomized Controlled 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 Arunangshu Deb 
Designation  PG Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital 
Address  Bharati Vidyapeeth (Deemed to be) University, Dental College and Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9719235186  
Fax    
Email  drarunangshu007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Wagmare 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Dental College and Hospital 
Address  Bharati Vidyapeeth (Deemed to be) University, Dental College and Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9850846820  
Fax    
Email  pramodw42@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arunangshu Deb 
Designation  PG Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital 
Address  Bharati Vidyapeeth (Deemed to be) University, Dental College And Hospital, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9719235186  
Fax    
Email  drarunangshu007@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Dhankawadi, Pune, 411043, Maharashtra, India. 
 
Primary Sponsor  
Name  Dr Arunangshu Deb 
Address  Bharati Vidyapeeth Dental College and Hospital, Pune, 411043 
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 Arunangshu Deb  Bharati Vidyapeeth Dental College and Hospital, Department of Periodontology  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Dhankawadi, Pune, Department of Periodontology, Room no 3.
Pune
MAHARASHTRA 		 9719235186

drarunangshu007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee of Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R651||Systemic inflammatory response syndrome (SIRS) of non-infectious origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  scaling and root planning  Comparison will be done between scaling and root palnning and scaling and root planning + transgingival photodynamic therapy (Tg-PDT) and following parameters will be compared like pocket probing depth, clinical attachment level 
Intervention  Transgingival photodynamic therapy (Tg-PDT) (430-490nm)  For the study we will be using IVOCLAR BLUE PHASE N MC (Light curing unit with blue light emitting diode) with following specifications Wavelength: 430-490 nm Probe diameter: 10 mm Power settings:800mw/cm2 Low-power LASERS + PS dyes are being used for treating periodontitis, but high cost, potential to cause eye damage, thermogenesis, production of plume are the main disadvantages of LASERs. LEDs can emit various wavelengths of light (blue, green, yellow, red). Lower directivity of LED light is suitable for application over large surfaces. Moreover, every dental clinic is equipped with a blue LED light curing unit (430-490nm) for curing composite restorations. Endogenous porphyrins produced by periodontopathogenic bacteria are effective chromophores for the blue wavelengths of light thus precluding the necessity of using an exogenous photosensitizer. Time for the procedure: 90 secs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Generalized Stage II, Grade B periodontitis
2)Probing Pocket Depth- 4-5 mm
3)Individuals with thin periodontal phenotype (gingival thickness ≤ 2mm)
4)Subjects having at least 20 remaining teeth
5) No systemic disease
 
 
ExclusionCriteria 
Details  1)Subjects who have undergone periodontal treatment within last 6 months
2) Subjects with history of systemic antibiotic administration within the last 6 months.
3) Smokers
4) Pregnancy or Lactation
5) Chronic high dose steroid use
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The efficacy of transgingival photodynamic therapy (Tg-PDT) using blue light LED (430-490nm) as an adjunct to subgingival mechanical instrumentation will be evaluated based on clinical and immunological parameters.   At baselinse and at 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the clinical and immunological effects of scaling and root planing along with transgingival photodynamic therapy (SRP + Tg–PDT) using blue LED light (430-490nm) and scaling and root planing (SRP) alone in the treatment of generalized periodontitis.  baseline and 6 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   20/06/2025 
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="2"
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   Low power LASERS + photosensitizer dyes are being used to treat periodontitis, but high cost, potential to cause eye damage, thermogenesis, production of plume are the main disadvantages of LASERS. LED can emit various wavelengths of light. Lower directivity of LED light is suitable for the application over large surfaces. Moreover, every dental clinic is equipped with a blue LED light curing unit (430-490nm) for curing composite restorations. Endogenous porphyrins produced by the periodontopathogenic bacteria are effective chromophores for the blue wavelengths of light thus precluding the necessity of using exogenous photosensitizer. 
Close