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CTRI Number  CTRI/2025/09/094594 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating efficacy of blood derived substitutes along with laser in the treatment of gum disease. 
Scientific Title of Study   Platelet-Rich Fibrin as an Adjunct to Laser Assisted New Attachment Procedure in the treatment of Periodontitis: Clinical Outcomes from a Randomized 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 A Geetha Sahithi 
Designation  Postgraduate student  
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore.
ANDHRA PRADESH
Nellore
ANDHRA PRADESH
524003
India 
Phone  9392971172  
Fax    
Email  sahithiallampati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sreenivas Nagarakanti 
Designation  Professor and Head of the department 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore.
ANDHRA PRADESH
Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sreenivas Nagarakanti 
Designation  Professor and Head of the department 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore.
ANDHRA PRADESH
Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Source of Monetary or Material Support  
Dr.A.Geetha Sahithi,Department of Periodontology,Room no.5, Narayana Dental College and Hospital,Chintareddypalem,Nellore-524003 
 
Primary Sponsor  
Name  Dr A Geetha Sahithi 
Address  Department of Periodontology,Room no.5, Narayana Dental College and Hospital,Chintareddypalem,Nellore-524003 
Type of Sponsor  Other [self- principal investigator] 
 
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 A Geetha Sahithi  Narayana Dental College and Hospital  Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore. ANDHRA PRADESH INDIA
Nellore
ANDHRA PRADESH 
9392971172

sahithiallampati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NarayanaDentalCollegeandHospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laser assisted new attachment procedure(LANAP)   scaling and rootplaning will be performed in patients with periodontal pockets greater than 5 mm.After scaling and root planing LANAP will be applied in control group.participants are evaluated at o,3,6 months for parameters like clinical attachment loss, probing depth ,bleeding on probing and visual analogue scale and compared with test group 
Intervention  Laser assisted new attachment procedure(LANAP)+ Platelet rich fibrin(PRF)  scaling and rootplaning will be performed in patients with periodontal pockets greater than 5 mm.After scaling and root planing LANAP+PRF will be applied in test group.participants are evaluated at o,3,6 months for parameters like clinical attachment loss,probing depth bleeding on probing and visual analogue scale  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Systemically healthy individuals.
Participants with age group of 18 to 55 years.
Participants with stage 2 and stage 3
periodontitis, and presence of at least one
tooth at each side of the mouth with one
residual pocket (PPD more than 5mm after phase 1
therapy). 
 
ExclusionCriteria 
Details  Systemic diseases
Pregnancy and Lactating women
Recent antibiotic use
Using tobacco in any form.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing depth(PD)
Clinical attachment level(CAL)

 
Baseline, 3 months,6 months)

 
 
Secondary Outcome  
Outcome  TimePoints 
Bleeding on probing(BOP)
Patient pain perception by visual analogue scale(VAS) 
Baseline, 3 months,6 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/12/2025 
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="1"
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   Patients with stage2, stage3 periodontitis will be selected from the outpatient department of Periodontology, based on inclusion and exclusion criteria. Participants with probing pocket depth of 5 mm in atleast one tooth at each side of the mouth with one residual pocket will be selected.

Fourty four participants will be selected and randomly assigned to test and control sites by computer generated randomization method.

Clinical attachment level, probing pocket depth, bleeding on probing and patient pain perception by visual analogue scale will be recorded at baseline, 3 months and 6 months.

After scaling and root planing of the selected sites in both groups.  Patients will be asked to return after one week for an assessment of their oral hygiene practices and additional procedures. Two quadrants with deep periodontal pockets will be chosen in each participant. The control areas will undergo LANAP treatment alone where this procedure will be done under local anesthesia. An optic fiber tip of Diode laser measuring 0.3s is placed parallel to the root surface, to carry away the epithelium lining of the pocket in coronal to apical motion to reflect the gingival flap. The first pass laser or troughing dissipates energy at 4 W, free running 100 milliseconds pulse expels the unhealthy lining of the pocket, and the pocket is closed by compressing gingival tissues against the root surface which creates a firm fibrin clot. While the test areas will receive a combination of LANAP and PRF. The prepared PRF will be compressed to a 1 mm thickness using gentle pressure between sterile tongue depressors. The flattened PRF will then be cut into smaller pieces and inserted into the periodontal pocket, filling it from the bottom to the gum line. A dull interdental gingivectomy knife will be employed to place the PRF membrane within the pocket.
 
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