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CTRI Number  CTRI/2025/09/094323 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Regeneration of the gums between front teeth using blood derived products and soft tissue laser. 
Scientific Title of Study   Comparative evaluation of liquid phase concentrated growth factors with and without haemolaser therapy in anterior papillary reconstruction-a randomized clinical trial 
Trial Acronym  LPCGF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Maturu Sai Sruthi 
Designation  Post Graduate Student 
Affiliation  Narayana Dental College and Hospital 
Address  Room no.5,2nd floor, Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore , Andhra Pradesh.

Nellore
ANDHRA PRADESH
524003
India 
Phone  6300066984  
Fax    
Email  maturusaisruthi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gunupati Sumanth 
Designation  Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Room no.5,2nd floor, Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore, Andhra Pradesh

Nellore
ANDHRA PRADESH
524003
India 
Phone  8885393855  
Fax    
Email  sumant2930@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gunupati Sumanth 
Designation  Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Room no.5,2nd floor, Department Of Periodontology ,Narayana Dental College and Hospital, Chintareddy palem, SPSR Nellore, Andhra Pradesh

Nellore
ANDHRA PRADESH
524003
India 
Phone  8885393855  
Fax    
Email  sumant2930@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr. Maturu Sai Sruthi 
Address  Room no.5, 2nd floor, Department Of Periodontology, Narayana Dental College and Hospital, Chintareddy palem, SPS Nellore District Pin code: 524003 
Type of Sponsor  Other [Self funded] 
 
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 Maturu Sai Sruthi  Narayana dental college and hospital  Room no 5,2 nd floor, department of periodontology, narayana dental college and hospital, chinthareddypalem, sps nellore
Nellore
ANDHRA PRADESH 
6300066984

maturusaisruthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe NDCHe  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  liquid phase concentrated growth factors   Injectable liquid phase concentrated growth factors and haemolaser therapy will be done where laser will be passed without activation of the diode laser tip.  
Intervention  liquid phase concentrated growth factors with haemolaser therapy   injectable liquid phase concentrated growth factors with haemolaser therapy with activated laser tip. This procedure is carried out at baseline and after a week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants with class I, class II, or class
III [Nordland and Tarnow classification]
anterior interdental papillary loss.
2. Non-smoker participants.
3. Participants who can maintain good oral
hygiene.
4. male and female participants with age
group of 18-50 years.
5.The participants who have a healthy
periodontal state  
 
ExclusionCriteria 
Details  1.Participants with any systemic diseases.
2. Consumption of drugs causing gingival
hyperplasia.
3. Participants with periodontal pocket and
malocclusion.
4.Pregnant and lactating women.
5. Participants who have coagulopathies.
6.Participants who are undergoing
orthodontic treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Anterior Interdental papillary gain.   Baseline, 4 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index
Bleeding index
Pain score-Visual Analogue Scale 
Gingival index, Bleeding index-Baseline, 4 weeks, 24 weeks
Visual Analogue Scale- Baseline, 4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/12/2025 
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="6"
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  
Systemically healthy Participants with anterior interdental papillary loss will be selected from outpatient Department of Periodontology, Narayana Dental College and Hospital, depending upon the inclusion criteria. After obtaining written informed consent, the selected participants will be subjected to scaling and root planing, oral hygiene instructions will be advised .The participants will be recalled after 4 weeks, and Anterior Papillary loss measurements will be taken using a UNC -15 probe and digital photographs. The participants will be selected and randomly assigned by computer generated method into two groups, Group 1 will receive injectable liquid phase concentrated growth factors and haemolaser therapy will be done where laser will be passed without activation of the diode laser tip. Group 2 will receive injectable liquid phase concentrated growth factors with haemolaser therapy with activated laser 
tip. Each papillary defect will be measured as a triangle with the height measured from the interdental contact point to the tip of papilla. Base will be measured as the distance between the proximal surfaces of the adjacent tooth surfaces at the tip of papilla. 10 ml of blood sample will be collected from antecubital region and transferred into the plain plastic tubes. The collected blood will be centrifuged, as per the sacco protocol and Liquid-phase concentrated growth factors are obtained by this method will be injected using an insulin syringe into the connective tissue layer at the base of the gingival papilla for both treatment groups after giving local anaesthesia at the recipient site. 
Haemolaser therapy will be achieved through Photo Biomodulation. Pocket marker is used to mark 4 bleeding points on the gingiva  between two anterior teeth, that is at (coronal third of papilla, apical third of the papilla, mesial and distal surfaces of the papilla). Later bleeding will be provoked by using curette inside the sulcus by applying pressure on junctional epithelium and supra crestal connective tissue. Photo biomodulation therapy will be applied with diode Laser( by following laser safety protocol like using protective eye shields )in two stages: First Stage: Photo Biomodulation Therapy (Pre-Bleeding) where in the fiber tip of diode laser will be inserted approximately 3-4 mm into the interdental papilla (at the base of the papilla). The laser will be applied to the designated spots around the gingiva. Second Stage: Photo Biomodulation Therapy (Post Bleeding). Again, the fiber tip will be inserted 
into the interdental papilla at the base, and laser treatment will be applied to the previously marked areas of the gingiva.  Haemolaser therapy will be done on baseline and after1 week in both groups. 
 
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