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CTRI Number  CTRI/2025/09/095434 [Registered on: 26/09/2025] Trial Registered Prospectively
Last Modified On: 25/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia
Dentistry 
Study Design  Other 
Public Title of Study   A split-mouth study comparing i-PRF with microneedling and low-level laser therapy on postoperative healing after open flap debridement in stage III periodontitis 
Scientific Title of Study   Comparative evaluation of i-prf with micro-needling and low-level laser application on post operative healing associated with open flap debridement in the treatment of stage iii periodontitis: A split mouth study 
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 K SUNEETHA 
Designation  PROFESSOR 
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India 
Phone  9290574051  
Fax    
Email  konerusuneetha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  N. Tejaswini 
Designation  PG student  
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India 
Phone  9014726887  
Fax    
Email  tejaswini07n@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K SUNEETHA 
Designation  PROFESSOR 
Affiliation  Drs. Sudha and Nageswara rao Siddartha institute of dental sciences 
Address  Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India 
Phone  9290574051  
Fax    
Email  konerusuneetha@gmail.com  
 
Source of Monetary or Material Support  
Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences, Chinnaoutapalli, Gannavaram mandal, Krishna district, Andhrapradesh, India, PINCODE:521286 
 
Primary Sponsor  
Name  Tejaswini N 
Address  Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences Room Number 3 Department of periodontics and Implantology Chinnaoutpalli Gannavaram Chinnaoutpalli Krishna ANDHRA PRADESH 521286 India  
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 Tejaswini N  Drs. Sudha and Nageswararao Siddartha institute of dental scinences  Department of Periodontics and Implantology room no. 3
Krishna
ANDHRA PRADESH 
9014726887

tejaswini07n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Drs Sudha and Nageswara rao siddartha institute of dental sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diode laser  open flap debridement followed by irradiation with low level diode laser having wavelength of 980nm & power 0.5W for 10 secs per each tooth in continuous non-contact mode. 
Intervention  I- PRF with microneedling  open flap debridement followed by microneedling on inner aspect of flap & injectable platelet rich fibrin application 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Systemically healthy individuals.
Patients with Stage-III, Grade-A periodontitis
Bilateral pockets with probing pocket depth greater than or equal to 6mm involving at least two or three teeth post phase-I therapy.
 
 
ExclusionCriteria 
Details  History of antibiotic therapy within 6months.
Uncooperative patients.
Poor oral hygiene.
Smokers.
Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque index
Gingival index
 
at baseline, 1 month, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Landry wound healing index   7th day, 14th day, 1 month. 
Probing pocket depth, Clinical attachment level, Gingival thickness   baseline & 3 months. 
 
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   Phase 3 
Date of First Enrollment (India)   09/10/2025 
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 Yet Recruiting 
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  

Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth, including the gingiva, periodontal ligament, and alveolar bone. It is primarily initiated by a dysbiotic bacterial biofilm but perpetuated by an exaggerated host immune response, leading to progressive tissue destruction and eventual tooth loss if untreated. The management of periodontitis aims to eliminate the microbial etiology, reduce inflammation, halt disease progression, and restore periodontal health. Initial therapy typically involves non-surgical approaches such as scaling and root planing combined with improved oral hygiene practices. In cases with persistent deep pockets or advanced disease, surgical interventions like open flap debridement, regenerative procedures, and use of biologics (such as platelet concentrates or growth factors) are employed to gain better access for debridement, facilitate tissue regeneration, and improve long-term outcomes. Injectable platelet-rich fibrin (i-PRF) is a concentrated autologous preparation rich in growth factors that promotes tissue regeneration and healing. When combined with micro-needling on the inner aspect of the flap (the connective tissue side), it enhances penetration and release of growth factors into the surgical site. This approach may accelerate soft-tissue healing, reduce post-operative inflammation, and improve clinical outcomes such as pocket depth reduction and attachment gain compared to flap surgery alone. Low-level laser therapy (LLLT) applied to the inner aspect of the flap during periodontal surgery enhances bio-stimulation, promoting faster and better-quality healing. By stimulating fibroblast activity, collagen production, angiogenesis, and reducing inflammation, LLLT improves tissue regeneration and reattachment to root surfaces.

 
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